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TI T L E: Vis u aliz ati o n of t he p a pill a t hr o u g h use of t he N u Vie w de vice i n p atie nts wit h F A P  
Pr ot oc ol Versi o n D ate: M a y 5, 2 0 2 2 1 3
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1. p u r p

T he N u Vie w d e vice is a si n gle-use distal e n d osc o pe attac h me nt t hat is i nte n de d t o facilitate direct vis ualizati o n of t he pa pilla wit h a f or war d vie wi n g e n d osc o pe i n or der t o eli mi nate t he nee d f or passa ge of t he m uc h b ul kier, n o n -i nt uiti ve, ris k pr o ne si de- vie wi n g e n d osc o pe t o vis ualize t he pa pilla. I n t his earl y feasi bilit y st u d y, t he N u Vie w de vice will be use d t o atra u maticall y i nsert an d na vi gate a c o n ve nti o nal f or war d -vie wi n g u p p er e n d osc o pe ( gastr osc o p e) fr o m i nserti o n at t he m o ut h, t hr o u g h t he es o p h a g us, t he st o mac h, a n d i nt o d u o de n u m t o vis ualize t he pa pilla i n p atie nts wit h fa milial a de n o mat o us p ol y p osis ( F A P). F A P is a here ditar y c o n diti o n i n w hic h a pers o n de vel o ps n u mer o us preca ncer o us p ol y ps, calle d a de n o mas, wit hi n t he s m all a n d lar g e i ntesti ne.  
T hese p atie nts als o h a ve a hi g h pre val e nce of a d e n o mas t hat d e vel o p o n t he d u o de nal pa pilla ,  
w hic h are partic ularl y har d t o vis ualize d ue t o t he c ur vat ur e a n d ge o metr y of t he s mall i ntesti ne .  
C urre ntl y, it is rec o m me n de d t hat F A P patie nts u n der g o serial e n d osc o pi c e xa ms t o assess t he c ol o n f or p ol y p f or mati o n e ver y year a n d e v er y 2 -3 years t o l o o k f or a de n o mas i n t he s mall i ntesti ne— s pecificall y o n t he d u o de nal pa pilla. T his re q uires t w o differe nt s pecialize d e n d os c o pes t o perf or m t he u p p er e n d osc o pic pr o ce d ur e. T h e first e n d os c o pe t h at t he e n d osc o pist uses is a f or war d faci n g gastr os c o pe, wit h w hic h t hey are a ble t o vis ualize t he st o mac h a n d p orti o ns of t he d u o de n u m. D ue t o t h e a nat o mic l ocati o n of t h e pa pilla, t he f or war d -vie wi n g e n d osc o pe is n ot a de q uate f or vis ualizati o n of t he pa pilla, a n d t her ef ore t he e n d osc o pist m ust s witc h t o a sec o n d s pecialize d e n d os c o pe (calle d a d u o de n osc o pe ) t hat all o ws f or si de vie wi n g b ut lac ks f or war d vis ualizati o n. T here are se veral w ell - k n o w n pr o ble ms wit h d u o de n osc o pes . First, t he y ar e n ot ori o usl y diffic ult t o sterilize a n d ha ve bee n li n ke d t o alar mi n gl y hi g h i nfecti o ns rates t hat ha ve i n s o me cas es r es ulte d i n patie nt deat hs2, 3 . T he F D A has e ve n iss ue d a call-t o-acti o n t o me dical de vice ma n ufact urers t o i n ve nt ne w dis p osa ble s ol uti o ns t o miti gate or eli mi nate t his pr o ble m4, 5 .  
Sec o n dl y, si de- vie wi n g e n d osc o pe t h at ar e c urre ntl y use d are diffic ult t o na vi gate b eca us e t he y lac k f or war d vie wi n g ca pa bilities. T he N u Vi e w de vice was d esi g ne d t o eli mi nate t he nee d f or a d u o de n osc o pe b y e na bli n g a f or war d faci n g gastr osc o pe t o als o ha ve s o me si de - vie wi n g ca pa bilities. I n t his earl y feasi bilit y st u d y, t he N u Vie w de vice will be use d wit h a f or w ar d f aci n g gastr osc o pe t o e n a ble F A P patie nts t o u n der g o t heir r o uti ne s cree ni n g e n d osc o pic e x a m. W e h y p ot hesize t hat t he mi ni mall y i n vasi ve e n d osc o pic pr oce d ure ma y offer t he f oll o wi n g be n efits:  
( 1) r e d uce d i nfecti o n rates d ue t o t h e eli mi nati o n of t he nee d f or a s p ecialize d si de-vie wi n g d u o de n osc o pe, ( 2) s h ort er pr oce d ur e ti me i ncl u di n g s h orter ge neral a nest hesia ti me b y eli mi nati n g t he nee d t o s witc h e n d os c o pes d uri n g t he pr oce d ur e, a n d ( 3 ) yi el d p ote ntiall y less tra u ma t o patie nt tiss ue d ue t o t he atra u m atic feat ur es of t he N u Vie w (o nl y nee di n g t o i nsert a n d re m o v e o ne e n d osc o pe as c o m par e d t o usi n g t wo differe nt e n d osc o pes t o c o m plete t he e xa mi nati o n).  
We pr o p os e a n earl y f easi bilit y st u d y t o deter mi ne if vis ualizati o n of t he p a pilla is p ossi ble usi n g a f or w ar d faci n g g astr os c o pe e q ui p p e d wit h t he N u Vie w . T he st u d y will i n v ol ve o nl y ot her wise healt h y F A P patie nts bet wee n t he a ge of 1 8 a n d 7 0 (see selecti o n criteri a f or a f ull descri pti o n).  
T he cli nical practice at V a n der bi lt U ni versit y Me dical Ce nter is t o first p erf or m t h e r o uti ne u p per e n d osc o pic e x a m wit h a f or war d - vie wi n g gastr osc o pe t o e val uate t he patie nt's es o p ha g us, st o mac h, a n d d u o de n u m. After t his has b ee n c o m plete d, t he f or w ar d-vie wi n g e n d osc o pe will be re m o ve d fr o m t he patie nt a n d o utfitte d wit h t he E n d o T heia N u Vie w. T he e n d osc o pe wit h N u Vie w will t he n be i nserte d tra ns orall y d o w n t he es o p ha g us, tra verse t he st o mac h, a n d be passe d i nt o t he d u o de n u m f or vis ualizati o n of t he pa pilla. After t he pa pilla is vis ualize d, t he e n d osc o p e wit h N u Vie w will be re m o ve d fr o m t he patie nt. As per sta n dar d of care, t he c o n v e nti o nal si de - vie wi n g e n d osc o pe will t he n be i nserte d tra ns or all y d o w n t he es o p ha g us, tra verse t he st o mac h, a n d be passe d i nt o t he d u o d e n u m f or vis ualizati o n of t he pa pilla. T he si de -vie wi n g e n d osc o pe will t he n be re m o ve d fr o m t he pati e nt.  
We pla n t o e nr oll 3 F A P patie nts w h o are alrea d y sc he d ule d t o u n der g o t heir sta n dar d of care e n d osc o pic e xa m. T he pri mar y e n d p oi nt of t he st u d y is s uccessf ul vis ualizati o n of t he pa pilla wit h t he N u Vie w platf or m.
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2. d e s c

T he E n d o T heia N u Vie w is a distal e n d osc o pe attac h me nt t y pe de vice w hic h is i nte n de d " t o be att ac he d t o t he dist al e n d of t he e n d osc o pe t o f acilit ate e n d osc o pic t her a py, t o be use d f or t he f oll o wi n g:  
Kee pi n g t he s uit a ble de pt h of e n d osc o pe's vie w fiel d Hel pi n g t he e n d osc o pe wit h bei n g i nserte d i nt o t he g astr oi ntesti n al tr act "  
T he E n d o T heia N u Vie w ca n be see n i n Fi g ur e 1 .  
  
Distal e n d osc o pe attac h me nt de vices are n ot ne w. T here ar e ma n y s uc h de vices c urre ntl y o n t he mar ket a n d i n use wit hi n t he cli nical setti n g. S o me si milar distal e n d osc o pe attac h me nt de vices o n t he mar ket ar e t he Arc E n d oc uff (K 1 5 1 8 0 1 ) a n d t he Re veal Distal Attac h me nt Ca p (K 1 4 0 3 1 5 ).  
T hese de vices f u n cti o n si milarl y t o t he N u Vie w de vice b y attac hi n g t o t he e n d osc o pe , mai ntai ni n g t he c orrect fiel d of vie w, a n d hel pi n g wit h atra u matic i nserti o n of t he e n d osc o pe. T he N u Vie w de vice mai ntai ns attac h me nt wit h t he e n d os c o p e t hr o u g h a pr ess -fitti n g attac h me nt t hat is ti g ht e n o u g h t o mai ntai n attac h me nt b ut n ot ti g ht e n o u g h t o da ma g e t he e n d osc o pe i n a n y wa y, si milar t o ot her F D A a p pr o v e d distal attac h me nts. Si milarl y, t he N u Vi e w d e vice h as a n atr a u matic i nserti o n ti p t hat is r o u n de d a n d ma d e fr o m a bi oc o m pati ble material , w hic h is mea nt t o facilitate atra u matic i nteracti o n wit h t he patie nt's tiss ue a n d e na ble safe i ns erti o n of t he e n d os c o pe i nt o t he patie nt . A n ot her as p ect of t he N u Vie w de vice is t hat it c o ntai ns s oft, fle xi ble si de pr ojecti o ns t o s m o ot h o ut t he m uc osal f ol ds i nsi de t he gastr oi ntesti nal ( GI) tract (si milar t o ot her F D A a p pr o ve d distal e n d osc o pe attac h m e nt de vices s u c h as t he E n d o C uff Visi o n ® (Ol y m p us A merica, P A, U S A )  
a nd t he E n d o Ri n gs ™ ( E N D O -AI D i nc., P A, U S A) , as well as a si de-vie wi n g reflecti ve s urface t hat will re direct a p orti o n of t he fiel d of vie w of t he e n d osc o pe. T he s oft pr ojecti o ns are pr o xi mall y -biase d, all o wi n g t he m t o f ol d d o w n o nt o t he e n d osc o pe b o d y d uri n g i nserti o n, a n d e vert u p o n retr acti o n t o e x pa n d a n d flatte n m uc os al f ol ds, t her e b y pr o vi di n g a n e n h a nce d vie w of t he l u me n as vie we d t hr o u g h t he si de-vie wi n g reflecti ve s urface. T hese feat ures are mea nt t o hel p kee p a s uita ble de pt h of t he e n d osc o pe's vie w fiel d a n d t o gi ve t he s ur ge o n a n e xcelle nt vie w of t he m uc osal li ni n g t o vis ualize tiss ue t o t he si de of t he e n d osc o pe, i n a d diti o n t o preser vi n g a p orti o n of t he n or mal f or war d-faci n g fiel d of vie w ca pa bilities. T he s ha pe of t he N u Vie w d e vice, t he fle xible si de pr ojecti o ns, a n d t he si de vie wi n g r eflecti ve s urf ace will ai d i n kee pi n g t he s uita ble de pt h of e n d os c o pe's fiel d of vie w a n d i ncr ease t he s ur ge o n's a bilit y t o vis ualize desir e d tiss ue tar gets b y s m o ot hi n g m uc osal f ol ds a n d pr e ve nti n g tiss ue fr o m c olla psi n g ar o u n d t he e n d os c o pe.  
T he de v ices use d i n t his st u d y are t he f oll o wi n g:  
I. Ol y m p us Gastr osc o pe GI F -H 1 9 0 w hic h is F D A clear e d f or e n d os c o p y a n d e n d osc o pic s ur ger y wit hi n t he u p per di gesti ve tract.  
II. N u Vie w c o nsisti n g of a s oft distal e n d osc o pe attac h me nt de vice (i n vesti gati o nal de vice ).  
III. Ol y m p us D u o de n osc o pe TJ F -Q 1 8 0 V w hi c h is F D A clear e d f or e n d osc o p y a n d e n d osc o pic s ur ger y wit hi n t he d u o de n u m.  
| T a bl e 1 . D e vi c e s us e d i n t his st u d y   |                  |                      |                                    |                 |
|-------------------------------------------------------|------------------|----------------------|------------------------------------|-----------------|
| Pr o d uct                                            | M o del          |                      | F D A I nf or mati o n             | A vaila bilit y |
| Ol y m p us  Gastr oi ntesti nal  Vi de osc o pe      | GI F -H 1 9 0    | K 1 1 2 6 8 0        | F D A cleare d a n d               |                 |
| c om merciall y a vaila ble                           |                  |                      |                                    |                 |
| N u Vie w De vice                                     | N ot a vaila ble | I n vesti gati o nal | N ot c o m merciall y  a vaila ble |                 |
| Ol y m p us                                           |                  | Vi de o              |                                    |                 |
| D u o de n osc o pe                                   | TJ F - Q 1 8 0 V | K 1 4 3 1 5 3        | F D A cleare d a n d               |                 |
| c o m merciall y a vaila ble                          |                  |                      |                                    |                 |
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3. p r o t

St u d y Title: Vis ualizati o n of t he pa pilla t hr o u g h use of t he N u Vie w de vi ce i n F A P patie nts.  
St u d y Desi g n: Earl y Feasi bilit y St u d y
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n u m ber of

St u d y P o p ul ati o n: A d ult F A P patie nts w h o are alrea d y sc he d ule d f or t heir sta n dar d of care u p per e n d osc o pic F A P scree ni n g e x a mi nati o n.  
St u d y D ur ati o n: U p per e n d osc o pic e xa mi nati o ns f or F A P are relati vel y s h ort d urati o n o utpatie nt pr oce d ures l asti n g 2 0- 30 mi n utes i n d urati o n. As is sta n dar d of car e at V U M C, a p ostpr oce d ur e f oll o w- u p p h o ne call is t he n c o n d uct e d 3- 5 da ys p ost- pr oce d ure.  
Sc he d ule: ( 1) Scree ni n g of patie nts f or meeti n g i ncl usi o n criteria; ( 2) R o uti ne u p per e n d osc o pic e x a mi nati o n wit h f or wa r d-vie wi n g e n d osc o pe; (3) Passa g e of t he f or war d -  
vie wi n g e n d osc o p e wit h N u Vie w; ( 4) Passa g e of t he c o n v e nti o nal si de -vie wi n g e n d osc o p e;  
( 5) F oll o w- u p p h o n e call 3 -5 da ys p ost e xa mi nati o n as per V U M C sta n dar d practice f or patie nts w h o ha ve u n der g o ne e n d osc o p y.
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3. 1. 2 st u

T he o bjecti ve of t his e a rl y fe asi bilit y st u d y is t o deter mi ne if vis ualizati o n of t he pa pilla is p ossi ble usi n g a f or war d-faci n g e n d os c o pe o utfitte d wit h t he N u Vie w de vice.
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3. 1. 3 st u

T his earl y feasi bilit y st u d y will be a pr os pecti ve cli nical trial i n w hic h 3 patie nts will be e nr olle d.  
All patie nts will u n der g o t heir r o uti ne yearl y u p per e n d osc o pic e xa mi nati o n usi n g t he c o n ve nti o nal f or war d-vie wi n g gastr osc o pe, si de -vie wi n g gastr osc o pe, a n d f or war d -vie wi n g gastr osc o pe e q ui p pe d wit h t he N u Vie w platf or m .  
3. 1. 3. 2 St u d y E n d p oi nts P RI M A R Y  
T he pri mar y st u d y e n d p oi nt will be s uccessf ul vis ualizati o n of t he pa pilla wit h a sta n dar d gastr osc o pe e q ui p pe d wit h t he N u Vie w platf or m .  
S E C O N D A R Y  
i. Ti me of pr oce d ure as r ec or de d b y researc h p ers o n nel ii. Ease of use of t he de vice as rec or de d b y t he e n d osc o pist via t h e c o m pleti o n of a N A S A tas k l oa d i n de x q uesti o n naire p ost- pr oce d ur e
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3. 1. 4 st u

T he N u Vie w is a n i n vesti gati o nal distal e n d osc o pe attac h m e nt t y pe d e vice t hat c o nsists of s oft, fle xi ble, a n d bi oc o m p ati ble 3 D pri nte d material, a n e m be d d e d o ptical mirr or , a n d bi o c o m pati ble a d hesi ve. All materials use d i n t he N u Vie w ha v e b ot h bee n c o nfir me d t o be bi oc o m pati ble a n d ha ve bee n s h o w n t o wit hsta n d a ut ocla ve sterilizati o n well . F or all bi oc o m pati bilit y a n d sterilit y verificati o n testi n g i nf or mati o n please refer t o A p pe n di x B .
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3. 1. 5 p artici

1. Male or fe mal e, 1 8 t o 7 0 years of a ge.  
2. A ble t o pr o vi de writte n i nf or me d c o nse nt.  
3. Ha ve F A P
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3. 1. 5. 2 e

1. Fe males w h o are pr e g na nt. As p art of r o uti ne pre - o perati ve car e, all fe males of c hil d beari n g p ote ntial will u n der g o eit her uri ne or bl o o d pre g na nc y testi n g.  
2. Ca ncer p ositi ve s u bjects or a n y patie nts c urre ntl y u n der g oi n g a n y treat me nt or t hera p y t o treat, c ur e, or miti gate ca ncer.  
3. Patie nts w h o d o n ot meet i ncl usi o n criteria 4. Patie nts w h o are u na bl e or u n willi n g t o pr o vi de i nf or me d c o ns e nt
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3. 1. 6. 1 scree

P ote ntial s u bjects will be i de ntifie d fr o m t he list of patie nts i n t he Va n der bilt U ni versit y Me dical Ce nter Di gesti ve Disease Ce nter w h o are sc h e d ule d t o u n der g o t heir e n d osc o pic scree ni n g f or F A P  
b y me m bers of t he V U M C cli nical researc h trai ne d pers o n nel tea m. T h os e p artici pa nts w h o e x press i nterest i n ta ki n g p art i n t he res ear c h st u d y will be as k e d t o si g n a writte n i nf or me d c o ns e nt t hat has bee n a p pr o ve d b y t he Va n der bilt U ni versit y Me dical Ce nter I R B. Partici pa nts will ha ve t he st u d y e x plai ne d t o t he m a n d will be gi ve n t he o p p ort u nit y t o read a n d re vie w t he c o nse nt d oc u me nt a n d ha v e a n y q uesti o ns a d dress e d. O n ce i nf or me d c o nse nt is o btai ne d, fi nal eli gi bilit y f or e nr oll me nt i nt o t he st u d y will be deter mi ne d b ase d o n t he i ncl usi o n/e xcl usi o n criteria.  
Partici pa nts will u n der g o pre -o p erati ve a n d p ost - o per ati ve pr o ce d ur es as p er r o uti ne sta n d ar d of care f or t heir V U M C e n d osc o pic e xa m. We a ntici pate e nr olli n g 3 patie nts t o c o m plete t he st u d y.
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3. 1. 6. 2 d

O nce t he patie nt has bee n s uccessf ull y pre pare d f or t he e n d osc o pic pr oce d ure a n d has bee n a d mi nistere d m o nit ore d a nest hesia care ( M A C) b y t he V U M C A nest hesia tea m as per r o uti ne care, t he f oll o wi n g ste ps will be f oll o we d.  
N ote: o nly ste p " b) " bel o w devi at es fr o m t he c urre nt st a n d ar d cli nic al pr actice f or u p per e n d osc o pic e x a mi n ati o n of F A P p atie nts. Ste p " b) " is w he n t he i nvesti g ati o n al N o n- Si g nific a nt Ris k ( N S R) device is use d a n d t he o nly ste p t h at is n ot us u ally perf or me d d uri n g F A P e n d osc o pic
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e x a mi n

a) E n d osc o pic assess me nt usi n g a st a n d ar d g astr osc o pe. T his assess me nt is t he first ste p i n t he r o uti ne F A P patie nt e n d osc o pic e xa mi nati o n. D uri n g t his ste p, t he e n d osc o pist i ntr o d uces a gastr osc o pe i nt o t he patie nt t o assess t he es o p ha g us, st o mac h, a n d d u o d e n u m f or p ol y ps. T his will be perf or me d per sta n dar d of car e wit h o ut de viati o n fr o m sta n dar d of care pr oce d ur e.  
b) E n d osc o p ic vis u aliz ati o n of t he p a pill a usi n g a g astr osc o pe e q ui p pe d wit h t he N u Vie w . After t he gastr osc o p e ass ess me nt is c o m plete a n d t he gastr osc o pe is re m o v e d fr o m t he patie nt, t he N u Vie w de vice will be attac he d t o t he gastr osc o pe, i ntr o d uce d i nt o t he patie nt, a n d t he pa pilla will be vis ualize d. Ste ps i n se q ue ntial or der are:  
1. T he N u Vie w d e vice's sterile pac ka gi n g will be i ns p ecte d a n d c o nfir me d i nt act 2. T he N u Vie w p ac k a ge will be o pe ne d 3. T he N u Vie w will t he n be presse d o nt o t he distal e n d of t he gastr osc o pe usi n g t he press -fitti n g attac h me nt feat ure a n d c o nfir me d t o be sec urel y f aste ne d 4. T he gastr osc o p e e q ui p pe d wit h t he N u Vie w will be i nserte d i nt o t he patie nt 5. T he gastr osc o pe will be na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d usi n g t he N u Vie w 6. T he gastr osc o p e e q ui p pe d wit h a N u Vie w will be re m o ve d fr o m t he p atie nt .  
c) D u o de n osc o pe vis u aliz ati o n of t he p a pill a as a sec o n d ary c o nfir m ati o n usi n g a n ot her cli nic ally acce pte d met h o d. F oll o wi n g pa pilla vis ualizati o n usi n g t he N u Vie w , t h e pa pilla will be vis ualize d a n d i ns pecte d a gai n usi n g a d u o de n osc o p e. T his will be perf or m e d i n t he sta n dar d met h o d, usi n g t he sta n dar d pr ot oc ol f or F A P p atie nts d uri n g t heir r o uti ne s cree ni n g u p per e n d osc o pic e xa mi nati o n. T he e n d os c o pist will i nsert a d u o d e n osc o pe i nt o t he p atie nt a n d n a vi gate t o t he d u o de n u m as is n or m al wit h r o uti ne e n d osc o pi c pr oce d ures f or p atie nts wit h F A P. Usi n g t his acce pte d cli nical met h o d, t he y will i ns pect t he p a pilla t o c o nfir m w hat was vis ualize d usi n g t he N u Vie w de vice. T his is a pr otecti o n i n li ne wit h w hat is o utli ne d i n 2 1 C F R 8 1 2 , w hic h states t hat a n y dia g n ostic N S R de vice s h o ul d ha ve a c o nfir mati o n of dia g n osis usi n g a sec o n d cli nicall y acce pte d met h o d. O nce t he pa pilla has bee n vis ualize d usi n g t he d u o de n osc o pe, t he d u o de n osc o pe will be re m o ve d fr o m t he patie nt i n t he sta n dar d cli nical met h o d.  
d) A ny a dverse eve nts occ urri n g d uri n g t he s ur gic al pr oce d ure will be d oc u me nte d. A n y a d verse e ve nts t hat occ ur d uri n g t he pr oce d ure will be d oc u me nte d a n d re p orte d i n acc or d a nce wit h 2 1 C F R 8 1 2 a n d Va n der bilt's I R B pr ot oc ols.
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3. 1. 6. 3 p

I n li ne wit h sta n dar d cli nical practice f or patie nts w h o ha ve recei ve d M A C at V U M C, t he p atie nt is o bser ve d f or 3 0 mi ns d uri n g t he i m me diate p ost- o perati ve peri o d a n d t hen release d t o a c ha per o ne t o lea ve t he e n d osc op y u nit. T he patie nt t he n recei ves a p ost-o perati ve p h o ne call 3 -5 da ys post pr oce d ure t o i n q uire a b o ut stat us of t he patie nt .  
Pri mar y E n d p oi nt: S uccessf ul vis ualizati o n of t he pa pilla wit h a sta n dar d gastr osc o pe e q ui p pe d wit h N u Vie w.  
Sec o n dar y E n d p oi nts:  
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i. Ti me of t he pr oce d ure will be rec or d e d.

ii. E n d osc o pist s ur ve y re gar di n g ease of us e a n d ot her s pecifics a b o ut t he N u Vi e w ( N A S A Tas k

L oa d I n de x)


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3. 1. 6. 4 p

Patie nts ma y be ter mi nate d fr o m t he st u d y f or t he f oll o wi n g reas o ns:  
A c ha n ge i n patie nt's healt h stat us t hat w o ul d precl u de c o nti n uati o n i n t he st u d y (e. g. car diac e ve nt d uri n g s ur gical pr oce d ure). If t his w o ul d o cc ur, t he patie nt will c o nti n ue t o be f oll o we d as  
per r o uti ne car e.  
If t he patie nt c ha n ges t h eir mi n d a n d re q uests t o be wit h dra w n fr o m st u d y s h o ul d t his occ ur, d ata will c o nti n ue t o be c ollecte d u nless t he patie nt re q uests i n writi n g f or data c ollecti o n t o cease.
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3. 1. 7 t a

| T a bl e 2 . St u d y Pr o c e d ur e s  Scr e e ni n g E n d osc o pic  E x a mi n ati o n                                                                                                                                                                                                                                                    | F oll o w u p   |    |
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| O bt ai n I nf or m e d C o ns e nt  R evi e w I ncl usi o n/ Excl usi o n Crit eri a  R evi e w M e dic al Hist or y  R o uti n e Pr e g n a nc y T esti n g ( uri n e or  bl o o d)                                                                                                                                                          | a               |    |
| G astr osc o p e ass ess m e nt of tiss u e                                                                                                                                                                                                                                                                                                    | X               |    |
| E n d osc o pic V ali d ati o n of t ar g et wit h  t h e N u Vi e w  E n d osc o pic c o nfir m ati o n of t ar g et  usi n g a st a n d ar d D u o d e n osc o p e                                                                                                                                                                           | X               |    |
| R evi e w A dv ers e E v e nts                                                                                                                                                                                                                                                                                                                 | X               | X  |
| E n d osc o pic P ost -O p  N A S A/ Q u esti o n n air e  ( a) P erf or m e d pr e -o p er ativ el y f or w o m e n of c hil d b e ari n g p ot e nti al ( b) T h e I nv esti g ati o n al St e p i n t his st u dy pr oc e d ur e. All ot h er st e ps wit hi n t h e pr ot oc ol will b e p erf or m e d p er t h e st a n d ar d of c ar e |                 |    |  
R evi e w M e dic al Hist or y  
R o uti n e Pr e g n a nc y T esti n g ( uri n e or  
bl o o d) a  
G astr osc o p e ass ess m e nt of tiss u e X  
E n d osc o pic V ali d ati o n of t ar g et wit h  
t h e N u Vi e w  
E n d osc o pic c o nfir m ati o n of t ar g et  
usi n g a st a n d ar d D u o d e n osc o p e X  
R evi e w A dv ers e E v e nts X X  
E n d osc o pic P ost -O p  
N A S A/ Q u esti o n n air e  
( a) P erf or m e d pr e -o p er ativ el y f or w o m e n of c hil d b e ari n g p ot e nti al  
( b) T h e I nv esti g ati o n al St e p i n t his st u dy pr oc e d ur e. All ot h er st e ps wit hi n t h e pr ot oc ol will b e p erf or m e d p er t h e st a n d ar d of c ar e  
3. 2 D at a A n al ysis  
I n t his earl y feasi bilit y st u d y, o ur pri mar y e n d p oi nt is s uccessf ul vis ualizati o n of t he pa pilla wit h  
a sta n dar d g ast r osc o pe e q ui p pe d wit h t he N u Vie w. Pr oce d ure ti me will als o be ca pt ure d as a sec o n dary  
e n d p oi nt.  
We will st o p e nr olli n g patie nts i n t his st u d y if:  
1. We d o n ot b elie ve t hat a d diti o nal patie nts s h o ul d u n der g o t h e pr o ce d ur e b eca use t he ris ks of t he pr oce d ure o ut wei g h t he p ote ntial be nefits t o partici pa nts a n d/ or  
2. A n u na ntici p ate d a d vers e eff ect w o ul d warra nt t hat t he st u d y be st o p pe d f or assess me nt of t he eff ect.
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3. 3 q u alit

T he c o n d u cti o n of t his earl y feasi bilit y st u d y will be o vers ee n b y t he PI. T h e PI will meet wit h t he s u b-i n vesti gat ors a n d r es earc h staff t o ass ur e pr ot oc ol a d her e nce a n d acc ur ac y of data c ollecti o n.  
Pri or t o st u d y i nitiati o n, all st u d y staff will be trai n e d re g ar di n g t he a p pr o ve d pr ot oc ol. All dat a will be e nter e d i nt o a p ass w or d pr ot ecte d c o m p uter data b ase b y q ualifi e d res ear c h staff. A n y i nc o nsiste ncies i n t he data will be rec o ncile d a n d d oc u me nte d a p pr o priat el y. As t here will be o nl y 3 s u bjects i n t his trial, all s u bject rec or ds will be r e vie we d b y t he PI .
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3. 4. 1. 1 defi

A dverse eve nt is defi ne d as a n y u n desira bl e e x perie nce ass o ciate d wit h t he use of t he de vi ce u n der st u d y t hat a p pears or w orse ns d uri n g t he cli nical st u d y fr o m t he peri o d c o m me nci n g wit h t he s ur gical pr oce d ure t hr o u g h t he ti me t he partici pa nt c o m pletes t he st u d y, a n d t hat ma y or ma y n ot be relate d t o t he i n v esti gati o nal de vice or st u d y r elate d pr oce d ur es.  
A rel ate d a dverse eve nt is a n e ve nt i n w hic h t here is a reas o na ble p ossi bilit y t hat t he i n vesti gati o nal de vice or st u d y r elate d pr oce d ures ca use d or c o ntri b ute d t o t he e ve nt.  
A n u n a ntici p ate d a dverse device effect is defi ne d as a n y s eri o us a d vers e e v e nt o n healt h or saf et y or a n y li fe-t hreate ni n g pr o ble m or deat h ca us e d b y, or ass ociate d wit h, a de vice, if t hat eff ect, pr o ble m, or d eat h w as n ot pre vi o usl y i de ntifie d i n nat ure, s e verit y, or de gree of i nci de n ce i n t he i n vesti gati o nal pla n or a n y ot her u na ntici pate d s eri o us pr o ble m ass ociate d wit h a de vice t hat relat es t o t he ri g hts, safet y, or welfar e of s u bjects.  
A seri o us a dverse eve nt is defi ne d as a n a d v erse e ve nt w her e b y t he patie nt o utc o me meets a n y of t he f oll o wi n g criteria:  
a. Res ults i n deat h b. Is life-t hreate ni n g ( defi n e d as a n e v e nt i n w hic h t he partici pa nt was at s u bsta ntial ris k of deat h at t he ti me of t he a d verse e ve nt, or us e or c o nti n ue d us of t he d e vice mi g ht ha ve res ulte d i n t he deat h of t he patie nt)  
c. Re q uires i n patie nt h os pitalizati o n d. Pr ol o n gs a n e xisti n g h os pitalizati o n e. Res ults i n persiste nt or si g nifica nt disa bilit y (s u bsta ntial disr u pti o n of a p e rs o n's a bilit y t o c o n d uct n or mal life f u ncti o ns)  
f. Res ults i n a c o n ge nital a n o mal y or birt h defect g. Re q uires me di cal or s ur gical i nter v e nti o n t o precl u de p er ma ne nt i m pair me nt of a b o d y f u ncti o n or pre v e nt per m a ne nt da ma g e t o a b o d y str uct ure.  
h. T he e ve nt d oes n ot fit a b o ve criteria ( a) t hr o u g h ( g), b ut ma y je o par dize t he patie nt a n d ma y re q uire me di cal or s ur gical i nter ve nti o n t o pr e ve nt a n y of (a) t hr o u g h ( g) a b o ve.
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3. 4. 1. 2 a

T he i n vesti gat or a n d s u b -i n vesti gat ors will assess o n a r o uti ne basis if a n y a d verse e ve nts o cc ur d uri n g t he e n d osc o pic pr oce d ure t hr o u g h t he ti me t he partici pa nt c o m pletes t he st u d y. All a d verse e ve nts/c o m plicati o ns t hat occ ur d uri n g t his ti me peri o d w het her de vi ce relate d or n ot will be re p orte d a n d rec or d e d.  
Pre -e xisti n g c o n diti o ns t hat are prese nt at t h e ti me of e nr ollme nt i nt o t he cli nical st u d y will be c o nsi dere d c o nc urre nt me dical c o n diti o ns a n d will n ot be r ec or d e d as a d v erse e ve nts u nless t h e s u bject e x perie n ces a w orse ni n g or c o m plicati o n of s uc h a c o n c urr e nt c o n diti o n, i n w hic h case t he a d verse e v e nt will be rec or de d a n d e val uate d b y t he i n vesti gat or.  
Patie nts will be cl osel y m o nit ore d i n a rec o v er y r o o m setti n g. All a vaila ble cli nical data, i ncl u di n g e xa m fi n di n gs, a n d cli nical i m pressi o ns, will be m o nit ore d. T he i n vesti g at or will e val uate a n y c ha n ges i n p h ysical stat us a n d will deter mi ne if t he c ha n ge is cli nicall y i m p orta nt a n d differe nt fr o m w hat is a ntici pate d i n t he c o urse of treat me nt.  
A n y e ve nts deter mi ne d b y t he PI t o be u n a ntici pat e d a d verse de vice effects will be re p ort e d t o t he re vie wi n g I R B a n d t he st u d y tea m as s o o n as p ossi ble b ut n ot m or e t ha n 1 0 w or ki n g da ys after t he i n vesti gat or first lear ns of t he eff ect.  
A n y u na ntici pate d a d v erse de vi ce effect will be i m me diatel y e val u ate d b y t he S p o ns or -  
i n vesti gat or. S h o ul d it be deter mi ne d t hat t he u na ntici pate d a d v erse d e vice eff ect pr ese nts a n u nreas o na bl e ris k t o st u d y s u bjects, t he st u d y or t he part(s) of t he st u d y t hat prese nts t hat ris k will be ter mi nate d as s o o n as p ossi ble b ut n ot later t ha n 5 w or ki n g da ys after t he S p o ns or-i n vesti gat or first recei ves n otice of t he effect.
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3. 4. 2 pr ot

Pr ot oc ol de viati o ns ar e d efi ne d as a n y i nci de nts i n v ol vi n g n o n -a d her e nce t o t he pr ot o c ol a n d ma y res ult fr o m acti o ns of t h e partici pa nt, i n vesti gat or, or staff. Pr ot oc ol de vi ati o ns will be rec or d e d a n d will be re p orte d t o t he re vie wi n g I R B per I R B p olic y. Pr ot oc ol de viati o ns i nte n de d t o pr otect t he life or p h ysical w ell - bei n g of a partici pa nt i n a n e mer ge nc y sit uati o n a n d a n y i nci de nce of fail ure t o o btai n i nf or m e d c o nse nt m ust b e re p orte d t o t he re vi e wi n g I R B as s o o n as p ossi ble b ut n o later t h a n 5 w or ki n g d a ys aft er t he e mer g e nc y o cc urr e d. E x ce pt f or s u c h a n e mer ge nt sit uati o n, c ha n ges t hat ma y affect t he scie ntific s o u n d ness of t he i n v esti gati o nal pla n or t he ri g hts, saf et y or welfar e of st u d y partici pa nts, m ust be a p pr o ve d b y t he I R B pri or t o i m ple me ntati o n.
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3. 4. 3 s p

T he s p o ns or will select o nl y q ualifie d i n vesti gat ors t o partici pate i n t he r esear c h st u d y a n d will pr o vi de i n vesti gat ors wit h a st u d y pr ot oc ol a n d t h e i nf or mati o n t h e y n ee d t o pr o perl y c o n d u ct t he st u d y. T he s p o ns or will als o ass ure m o nit ori n g is c o n d ucte d acc or di n g t o t he m o nit ori n g pla n. I R B  
a p pr o val of t he st u d y m ust be o btai ne d pri or t o start of t he st u d y a n d t his d oc u me ntati o n will be ke pt o n file. T he s p o ns or will pr o m ptl y n otif y t h e I R B of a n y si g nifica nt ne w i nf or mati o n a b o ut t his i n vesti gati o n.  
3. 4. 4 I n vesti g at or Res p o nsi bilities I n v esti gat ors are res p o nsi ble f or c o n d ucti n g t he st u d y i n acc or da n ce wit h t he si g ne d I n v esti gat or's Letter of A gr ee me nt, t he i n vesti gati o nal pla n, a n y I R B i m p ose d c o n diti o ns, a n d a p plica ble F D A  
re g ulati o ns f or pr ot ecti n g t he ri g hts, saf et y, a n d welfar e of s u bjects u n der t he i n vesti gat or's care, a n d f or o btai ni n g i nf or me d c o nse nt fr o m eac h researc h p artici pa nt pri or t o a n y st u d y-relat e d pr oce d ur es. I n vesti gat ors are als o res p o nsi ble f or m ai ntai ni n g c o ntr ol of t he i n vesti gati o nal de vice.  
T his earl y feasi bilit y st u d y is bei n g c o n d u cte d at V a n der bilt U ni versit y Me dical Ce nter, Nas h ville, T N, U S A . I n v esti gat ors ma y deter mi ne if p ote ntial s u bjects w o ul d be i ntereste d i n ta ki n g part i n t he i n vesti gati o n pri or t o I R B a p pr o val, b ut writte n i nf or me d c o nse nt will n ot be o btai n e d fr o m st u d y partici pa nts a n d stu d y partici pati o n will n ot be all o we d u ntil I R B a p pr o val is recei ve d.  
T he i n vesti gati o nal de vice will o nl y be use d o n researc h s u bjects wit h t he i n vesti gat or's s u per visi o n a n d will n ot be use d o n a n y p ers o n w h o is n ot a ut h orize d u n der 2 1 C F R 8 1 2 t o recei ve it.  
I n v esti gat ors will discl ose acc ur ate fi na n cial i nf or mati o n t o all o w c o m plete a n d acc ur ate certificati o n or discl os ure state me nts t hat ma y be re q uire d. T his i nf or mati o n will be c ollecte d via F D A F or ms 3 4 5 4 a n d 3 4 5 5, as a p pr o priate, a n d will be u p date d pr o m ptl y if a n y rele v a nt c ha n ges occ ur d uri n g t he c o urse of t he cli nical st u d y a n d f or o ne year aft er t h e c o m pleti o n of t his st u d y.
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3. 4. 5 selecti o

All cli nical i n vesti gat ors ta ki n g part i n t his st u d y are acc o m plis he d gastr o i ntesti nal e nd osc o pists w h o c o m m o nl y perf or m e n d osc o pic pr o ce d ur es as part of t heir practice . All u n dersta n d a n d will c o m pl y wit h t heir res p o nsi bilities re gar di n g a d h er e nce t o t he a p pr o ve d pr ot oc ol a n d t he si g ne d I n v esti gat or's Letter of A gree me nt. T he r esearc h pr ot oc ol will ta ke place at Va n der bilt U ni versit y Me dical Ce nter wit h the principal i n vesti gat or ( PI) b ei n g Dr. Keit h L. O bstei n . His c urric ul u m vit ae is i ncl u de d i n A p pe n di x C .  
3. 4. 6 I nf or m e d C o nse nt O nce a p ote ntial st u d y s u bject has bee n i de ntifie d, a me m ber of t he resear c h tea m will prese nt t he researc h st u d y t o t he s u bject i n pers o n, via p h o n e, or via s ec ur e electr o ni c tr a nsfer (e. g. s ec ur e e mail or M y Healt h at Va n der bilt electr o nic p ortal). T he p ote ntial partici p a nt will be pr o vi de d wit h a c o p y of t he c o nse nt f or m t o rea d a n d will be pr o vi de d wit h a n o p p ort u nit y t o as k q uesti o ns. O nce t he st u d y partici pa nt's q uesti o ns ha ve bee n a ns w ere d a n d pri or t o perf or mi n g a n y st u d y -relate d pr oce d ur e, a n I R B -a p pr o ve d c o nse nt for m will be si g ne d a n d date d b y t he st u d y partici pa nt a n d b y t he pers o n o btai ni n g i nf or me d c o nse nt. A c o p y of t he si g ne d c o nse nt f or m will be pr o vi de d t o t h e s u bject a n d t he i nf or me d c o nse nt pr ocess will be d oc u me nte d i n t he st u d y partici pa nt's me dical rec or d.
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3. 5 refere nces

Please see t he f o ot n otes t hr o u g h o ut a p plicati o n.
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4. 1 descri pti o

T here ar e i n her e nt ris ks c o m m o n t o all e n d osc o pic pr oce d ur e s. T hese ris ks are n ot u ni q ue t o t his rese arc h a n d are liste d i n t he ta ble bel o w.  
| T a bl e 3 . Ris k A n al ysis a n d Miti g ati o n                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
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| Ris ks w hic h are N O T U NI Q U E t o t his rese arc h  P ote nti al  H az ar d Res ult a nt H ar m Ris k A n al ysis Disc ussi o n a n d Miti g ati o n Str ate g y  St a n d ar d of c are f or p atie nts wit h F A P is t o u n der g o a  r o uti ne e n d osc o pic ex a mi n ati o n of t he m uc os al li ni n g t o  assess p oly p f or m ati o n every 1 ye ar f or c ol o n osc o py a n d  every 2-3 ye ars f or u p per e n d osc o py . T he s ur gic al risks  descri be d are n o gre ater f o r patie nts receivi n g t he  i nvesti g ati o n al pr oce d ure t h a n f or st a n d ar d of c are  pr oce d ures f or t his p o p ul ati o n. P atie nts will be c o u nsele d  a b o ut t hese risks.  M o nit ore d  A nest hesi a  C are ( M A C)  Risks i ncl u de b ut are  n ot li mite d t o  blee di n g, i nfecti o n,  a n d/ or nee d f or  a d diti o n al s ur gery.  E n d osc o pic  pr oce d ure  Risks of a nest hesi a  i ncl u de b ut are n ot  li mite d t o str oke a n d  de at h.  T he risks descri be d are n o gre ater f or p atie nts receivi n g t he  i nvesti g ati o n al pr oce d ure t h a n tr a diti o n al ex a mi n ati o n.  P atie nts will be c o u nsele d a b o ut t hese risks. |  
T here als o ris ks w hic h are u ni q ue t o t his rese arc h . T hese ris ks, al o n g wit h desi g ne d a n d i m ple me nte d ris k c o ntr ols are liste d i n t he ta ble bel o w. A n i n-de pt h disc ussi o n of eac h of t hese u ni q ue ris ks a n d t he i m ple me nte d ris k c o nt r ols t o miti gate t hese ris ks f oll o ws t he ta ble.  
| T a bl e 4 . Ris k A n al ysis a n d Miti g ati o ns ( u ni q u e t o t his r e s e ar c h).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
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| Ris ks w hic h are U NI Q U E t o t his rese arc h  P ote nti al  H az ar d Res ult a nt H ar m Ris k A n al ysis Disc ussi o n a n d Miti g ati o n Str ate g y  Dist al e n d osc o pe att ac h me nt devices d o h ave a s m all c h a nce  of device det ac h me nt fr o m t he e n d osc o pe. O ur revie w of t he  M A U D E d at a b ase f or ot her dist al e n d osc o pe att ac h me nt  devices s h o ws t h at eve n w he n t he device d oes det ac h fr o m t he  e n d osc o pe it d oes n ot c a use h ar m t o t he p atie nt ( see M A U D E  d at a i n A p pe n dix A ). If t he device d oes det ac h d uri n g use,  the device is retrieve d usi n g e n d osc o pic t o ols s uc h as a R ot h  net or a n alli g at or f orce ps as is st a n d ar d pr actice f or  retriev al of f orei g n b o dies i n t he g astr oi ntesti n al tr act.  P atie nts will be c o u nsele d a b o ut t hese risks. F or m ore  i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d  disc ussi o n here.  N o n - bi oc o m p ati ble  m ateri al use d  Device  Det ac h me nt  fr o m t he  e n d osc o pe  w hile  de pl oye d i n  t he p atie nt  Sli g ht del ay i n  p atie nt c are d ue t o  device retriev al  All m ateri als a n d a d hesives use d i n t he device c o nstr ucti o ns  Aller gic re acti o n are bi oc o m p ati ble. Ple ase refer t o A p pe n dix B f or  bi oc o m p ati bility i nf or m ati o n/testi n g certific ates. We h ave |  
| i n t he device                                             | deter mi ne d t h at bec a use all m ateri als use d i n t he device are  bi oc o m p ati ble a n d h ave bee n teste d t o t he a p pr o pri ate I S O  1 0 9 9 3 st a n d ar d t h at t he risks ass oci ate d wit h  bi oc o m p ati bility are acce pt a ble a n d d o n ot p ose seri o us risk  t o t he he alt h, or welf are of t he s u bject. P atie nts will be  c o u nsele d a b o ut t hese risks. F or m ore i nf or m ati o n re g ar di n g  t his risk ple ase see a det aile d disc ussi o n here.  M ateri als h ave bee n selecte d wit h t he pr o p ose d steriliz ati o n  pr ocess i n mi n d. All m ateri als use d i n t he c o nstr ucti o n of t he  device h ol d u p well t o a ut ocl ave steriliz ati o n. T he s afety a n d  verific ati o n d at a perf or me d o n t he device as p art of t his  a p plic ati o n w as perf or me d p ost steriliz ati o n t o give  c o nfi de nce t h at t he device c a n be sterilize d a p pr o pri ately.  F urt her, e n d osc o py wit hi n t he GI is c o nsi dere d a cle a nc o nt a mi n ate d ty pe pr oce d ure, me a ni n g t h at w hile t he device  is p ack a ge d sterile, t he e nvir o n me nt itself is n ot sterile.  Sterility will be m ai nt ai ne d per t he st a n d ar d of c are. P atie nts  will be c o u nsele d a b o ut t hese risks. F or m ore i nf or m ati o n  re g ar di n g t his risk ple ase see a det aile d disc ussi o n here.                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                             |
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| N o n -sterile  N u Vie w  device use d                     | P atie nt i nfecti o n                                                                                                                                                                                                                                                                                                                                                                                   | We h ave ex a mi ne d t he M A U D E d at a b ase f or device  bre ak a ges f or a si mil ar ty pe device a n d o ne of t he m ost  c o m m o nly see n device f ail ures f or t his ty pe of device is t h at  of pr ojecti o n bre ak a ges ( See M A U D E d at a i n A p pe n dix A ).  We h ave t ake n t his i nt o acc o u nt d uri n g t he desi g n of t he  device a n d h ave cre ate d re d u n d a ncy t hr o u g h t he a d diti o n of  a s afety l o o p s o t h at e ac h pr ojecti o ns nee ds at le ast t w o  i n de pe n de nt bre ak a ges f or a ny o ne pr ojecti o n t o bre ak off  fr o m t he device. Si mil arly, we h ave desi g ne d o ut t he t hi n pi nj oi nt f ail ure z o ne w hic h we believe c o ntri b utes t o t he  m aj ority of t he bre ak a ges f or t he Arc E n d oc uff device t h at  o ur N u Vie w device is desi g ne d after. T o get her, t hese  activities h ave le d us t o deter mi ne d t h at t his risk h as bee n  miti g ate d t o a n acce pt a ble level t hr o u g h t he i m ple me nte d risk  c o ntr ols a n d as s uc h d oes n ot p ose seri o us risk t o t he he alt h,  or welf are of t he s u bject. P atie nts will be c o u nsele d a b o ut  t hese risks. F or m ore i nf or m ati o n re g ar di n g t his risk ple ase  see a det aile d disc ussi o n here.                                                                                                                                                                                                                                                                                                                             |
| Device  pr ojecti o ns  bre ak a ge                         | Sli g ht del ay i n  p atie nt c are d ue t o  retriev al                                                                                                                                                                                                                                                                                                                                                | We h ave miti g ate d t his risk t hr o u g h i n here nt desi g n, h avi n g  m a de t he press fitti n g att ac h me nt fe at ure s uc h t h at it will  o nly c o me i nt o c o nt act wit h t he si de pr ofile of t he e n d osc o pe  a n d will st ay sec urely i n pl ace wit h o ut c overi n g t he fr o nt f ace |
| Irri g ati o n  a n d/ or  ill u mi n ati o n  bl ock a ges | of t he e n d osc o pe w here t he s ucti o n a n d irri g ati o n c h a n nels                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                             |
| Sli g ht del ay i n  p atie nt c are                        | are l oc ate d. F urt her we h ave i nc or p or ate d a dr ai n a ge h ole  l oc ate d i n t he b ack b o ne of t he device t o ai d i n irri g ati o n. We  h ave als o r u n verific ati o n tests t o e ns ure t h at irri g ati o n  a n d/ or ill u mi n ati o n h ave bee n m ai nt ai ne d. F or m ore  i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d  disc ussi o n here. |                                                                                                                                                                                                                                                                                                                             |
| Tr a u m atic  fe at ures,                                  | Tiss ue tr a u m a                                                                                                                                                                                                                                                                                                                                                                                       | We h ave desi g ne d t he N u Vie w usi n g a s oft, flexi ble,  bi oc o m p ati ble m ateri al t h at s h o ul d re d uce tiss ue tr a u m a. We                                                                                                                                                                           |  
h ave i ncl u de d a n atr a u m atic i nserti o n ti p wit h a n atr a u m atic  
pr ofile fe at uri n g a s m o ot h r o u n de d d o me. We h ave als o  
r o u n de d all ex p ose d e d ges o n t he device i n acc or d a nce wit h  
h u m a n f act ors H E -7 5 g ui d a nce t o f acilit ate m ore atr a u m atic  
i nserti o n a n d we h ave desi g ne d t he device i n acc or d a nce f or  
m axi m u m i nserti o n wi dt h i n acc or d a nce wit h t he  
i nter n ati o n al e n d osc o pe st a n d ar d I S O- 8 6 0 0. We h ave  
deter mi ne d t h at w hile tiss ue tr a u m a is a n i n here nt risk t o all  
dist al e n d osc o pe att ac h me nt ty pe devices s uc h as t he  
N u Vie w, t his risk h as bee n miti g ate d t o a n acce pt a ble level  
t hr o u g h t he i m ple me nte d risk c o ntr ols a n d as s uc h d oes n ot  
p ose seri o us risk t o t he he alt h, or welf are of t he s u bject.  
P atie nts will be c o u nsele d a b o ut t hese risks. F or m ore  
i nf or m ati o n re g ar di n g t his risk ple ase see a det aile d  
disc ussi o n here.  
De vice det a c h m e nt ris k miti g ati o ns:  
U ni nte nti o nal de vice d et ac h me nt fr o m t he e n d os c o pe is c urre ntl y t h e m ost pr o ba ble ris k f or t h e N u Vie w d e vice. If a n u ni nte nti o nal detac h me nt ha p pe ns bef ore t he d e vi ce is i nserte d i nt o t he patie nt t here is n o ris k t o t he patie nt or us er. T h e user w o ul d si m pl y nee d t o o pe n a n d attac h a ne w N u Vie w de vice a n d t he n i nsert t he e n d osc o pe wit h attac he d N u Vie w d e vice n or mall y. If t h e u ni nte nti o nal detac h me nt ha p pe ns aft er t he e n d os c o pe has bee n i ns erte d i nt o t he patie nt, t he de vice will nee d t o be retrie ve d bef ore t he pr o ce d ure ca n c o nti n ue. Base d o n o ur r e vie w of t he M A U D E  
data base f or si milar distal e n d osc o pe attac h me nt t y pe de vices, u ni nte nti o nal de vice detac h me nt wit hi n t he patie nt is t he m ost c o m m o n a d vers e e ve nt r e p orte d f or t his t y pe of d e vice. W hile t he m ost c o m m o n, it d oes n ot a p pear t o be a si g nifica nt ris k t o t he patie nt. Wit hi n o ur re vie w of t he M A U D E data base, u ni nte nti o nal detac h me nt wit hi n t he patie nt w as re p ort e d 2 4 ti mes. N o ne of t hese d etac h me nt e ve nts res ulte d i n har m t o t he patie nt. I nstea d, t he y r e p orte d a sli g ht dela y t o t he pr oce d ures d ue t o t he de vi ces nee di n g t o be retrie ve d b y a mi ni mall y i n vasi ve met h o d s uc h as t hr o u g h t he use of a R ot h net  
(Fi g ure 2 ) i n li ne wit h A S G E f orei g n b o d y re m o val g ui deli nes here . F or m ore details o n t he M A U D E data b ase re p orts relati n g t o de vice detac h me nt f or si milar t y pe de vices t o t he N u Vie w de vice ( a n d h o w we use d t his i nf or mati o n t o dri ve a p pr o priate ris k c o ntr ols d uri n g t he desi g n a n d de vel o p me nt pr ocess) p lease refer t o A p p e n di x A .  
We ha ve miti gate d t his ris k of u ni nte nti o nal detac h me nt i n part b y desi g n c ha n ges t o t he N u Vie w de vice's press fitti n g feat ure. We ha v e u n d ersize d t his press fitti n g t o i ncreas e t he f orce wit h w hic h  
  
it attac hes t o t he e n d osc o pe. C urre ntl y t he e n d osc o pe is 9. 9 m m i n dia meter w hile t he N u Vie w press fitti n g a n u n dersize d 9. 2 5 m m. T he N u Vie w ca n still fit o n t he e n d osc o pe easil y e ve n t h o u g h it is u n dersize d d ue t o t he bi oc o m pati ble elastic material t hat it is c o nstr ucte d fr o m. T his material is i deal f or t he pr ess fitti n g d ue t o its hi g h resilie nce, e xcelle nt stretc h a n d c o m pressi o n pr o perties, a n d te nsile str e n gt h. F or a f ull c haract erizati o n of t his material pleas e r ef er A p p e n di x B . T h ese material pr o perties all o w t he press fitti n g t o ti g htl y a n d sec urel y fit o nt o t he e n d osc o pe, w hile still bei n g s oft a n d fle xi ble s o as n ot t o da ma ge t he e n d osc o pe itself. T he m aterial is als o bi oc o m pati ble a n d easil y sterilize d h a vi n g bee n teste d t o t h e i nter nati o nal I S O-1 0 9 9 3 bi oc o m pati bilit y sta n dar d a n d s h o w n t o mai ntai n material pr o perties r o b ust n ess after c o m m o n sterilizati o n met h o ds s uc h as a ut ocla ve sterilizati o n, ga m ma sterilizati o n, e -b ea m sterilizati o n, a n d Et h yle ne O xi de ( Et O)  
```
Sterilizati o n (refer t o A p pe n di x B f or bi oc o m pati bilit y a n d sterilizati o n data/re p orts).

T he N u Vi e w h as als o u n der g o ne be nc h a n d usa bilit y testi n g t o ai me d at assessi n g a n d e ns uri n g

t hat t he N u Vie w mai ntai ns attac h me nt t o t he e n d osc o pe. T he f oll o wi n g is a brief s u m mar y of t h e

i nter nal be n c h a n d user t esti n g c o m plete d t o verif y t hat t he N u Vie w will mai ntai n attac h me nt t o

t he e n d osc o pe.

a. Stre n gt h of att ac h me nt assess me nt:

We ha ve c h aracterize d t he f orce r e q uire d t o re m o v e t he N u Vie w fr o m t he e n d osc o pe . T he

detac h me nt f or ce was meas ure d b y pr o perl y affi xi n g t he N u Vie w de vice t o t he e n d osc o pe

ti p a n d m o u nti n g t he e n d osc o pe t o t he 3 D pri nte d detac h me nt f orce ji g. T he test set u p f or

t his e x peri me nt ca n b e see n i n t he fi g ure b el o w.


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T he N u Vie w w as m o u nte d i nt o a cla m p a n d a l oa d cell was attac h e d t o t he cla m p o n o ne si de a n d a m ot or o n t he ot her si de. T he m ot or w as pr o gra m me d t o retr act u ntil t he N u Vie w beca me f ull y d etac h e d fr o m t he e n d osc o pe a n d t he detac h me nt f orce w as rec or de d. T o e ns ure e n d os c o pe attac h me nt r o b ust ness ei g ht differe nt N u Vie w de vices were attac he d/ detac he d fr o m t he e n d osc o p e ti p at least 1 5 ti mes eac h. T hr o u g h t hese tests, it was f o u n d t hat an a v era g e detac h me nt f or ce of 9. 6 4 N acr oss all e x peri me nts a n d mi ni m u m detac h me nt f orce of 7. 9 2 N was re q uir e d t o f ull y d etac h t he N u Vie w fr o m t he gastr osc o p e.  
T his re m o val f or ce gr eatl y e xcee ds t he e x p ecte d f orces o n t he N u Vie w w h e n de pl o ye d i n t he patie nt gi vi n g c o nfi d e nce t hat t h e de vice will n ot u ni nte nti o nall y detac h d uri n g t he pr oce d ur e. N o s yste mic de vice f ail ures or br ea ka ges wer e o bser ve d i n t he se e x peri me nts .  
T he o nl y n o n perf or ma n ce o bser ve d i n t h ese e x peri me nts was t h at o ne of t he pr ess -fit c ollars f or a si n gle de vi ce start e d t o s h o w a d hesi ve fail ure o n t he 1 5 t h ti me of bei n g reattac h e d a n d u nattac he d fr o m t he e n d osc o pe. We belie ve t his was i n part d ue t o t he e x peri me ntal set u p, w her e hi g her a n d re p eate d str ess was place d o n t his sea m t ha n w o ul d be see n i n cli nical use w here t h e p h ysicia n w o ul d attac h t he de vi ce o n ce a n d t he n r e m o ve t he de vice o nce at t he e n d of t he pr oce d ure. I n t otal, of t he 1 2 0 attac h me nt/ detac h me nts perf or me d o nl y o ne si n gle de vice s h o w e d a si n gle a d hesi ve iss ue o n t h e last of t he 1 5 attac h me nt/ detac h m e nt r u ns. Of all t he ot h er de vi ces teste d, n o fail ur e was detecte d; t his e nforces t he ass u m pti o n t hat t his fail ure was a o ne -off test set u p or ma n ufact uri n g fail ure.  
D uri n g a n act ual pr oce d ure, w e e x p ect t he N u Vie w t o be attac he d o nce at t he be gi n ni n g of t he pr oce d ure a n d t he n detac he d fr o m t he e n d osc o pe o nce u p o n c o m pleti o n of t he pr oce d ur e. T his dat a gi ves c o nfi de nce t hat t he e n d osc o pe attac h me nt press fitti n g is m ore t ha n s ufficie ntl y r o b ust.  
| T a bl e 5 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e N u Vi e w fr o m t h e e n d os c o p e  De vice A ver a ge F orce [ N] Mi n F orce [ N] M a x F orce [ N]   |          |        |          |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|----------|
| 1                                                                                                                                                                                             | 9. 4 6   | 8. 7 2 | 1 0. 2 3 |
| 2                                                                                                                                                                                             | 9. 5 0   | 9. 0 0 | 1 0. 4 0 |
| 3                                                                                                                                                                                             | 8. 2 2   | 7. 9 2 | 8. 6 5   |
| 4                                                                                                                                                                                             | 1 0. 1 9 | 9. 3 0 | 1 1. 9 1 |
| 5                                                                                                                                                                                             | 1 0. 1 0 | 9. 5 6 | 1 1. 6 5 |
| 6                                                                                                                                                                                             | 9. 9 6   | 8. 9 5 | 1 0. 6 4 |
| 7                                                                                                                                                                                             | 9. 5 4   | 8. 6 9 | 1 0. 2 0 |
| 8                                                                                                                                                                                             | 1 0. 0 9 | 9. 5 8 | 1 0. 7 9 |
| Over all aver a g e:                                                                                                                                                                          | 9. 6 4   | 8. 9 7 | 1 0. 5 6 |  
b. C o m p ari n g det ac h me nt f orces t o a n F D A a p pr ove d dist al e n d osc o pe att ac h me nt device:  
We ha v e c o m p are d t he f orce re q uir e d t o re m o v e t he N u Vie w fr o m t he E n d osc o pe t o a n F D A a p pr o ve d distal e n d osc o pe attac h me nt de vice si milar t o t he N u Vie w, calle d t he Arc E n d oc uff . T his is t o e ns ure t hat t he N u Vie w de vice is at least as s afe fr o m detac h me nt e ve nts as t he Ar c E n d oc uff. T he det ac h me nt f or ce was meas ure d b y attac hi n g t he Ar c E n d oc uff t o a n e n d os c o p e a n d p ulli n g it off t he e n d osc o pe usi n g a cali brat e d f orce ga u ge si milar t o h o w t he N u Vie w detac h m e nt f orces w ere c h aracterize d. T hr o u g h t hese tests, it was f o u n d t hat a n a v er a ge detac h me nt f orce of 8. 9 N a n d mi ni m u m f orce of 6. 4 N is re q uire d t o f ull y detac h t he Ar c E n d oc uff fr o m t h e e n d osc o p e. A s u m mar y of t he f orces re q uire d t o r e m o ve t he Arc E n d oc uff fr o m t he e n d osc o pe ca n b e see n i n t he ta ble bel o w.  
| T a bl e 6 . S u m m ar y of t h e f or c e r e q uir e d t o d et a c h t h e Ar c E n d o c uff ( F D A a p pr o v e d d e vi c e)  De vice A ver a ge F orce [ N] Mi n F orce [ N] M a x F orce [ N]  1 1 1. 3 6 9. 6 0 1 4. 6 0  2 7. 1 4 6. 4 0 8. 4 0  3 8. 8 8 7. 8 0 1 1. 2 0  4 8. 1 6 7. 0 0 9. 0 0   |
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T his e x peri me nt de m o nstrates t hat t he mi ni m u m N u Vie w detac h me nt f or ce e x cee ds t he mi ni m u m a vera ge f orce of t he E n d o c uff, i n dicati n g t hat t he N u Vie w is less li kel y t o detac h  
```
fr o m t he e n d osc o p e w he n c o m pare d t o a v er y si milar F D A a p pr o ve d d e vice.

c. Assessi n g cli nic ally relev a nt f orces pl ace d o n t he N u Vie w i n a p orci ne c ol o n m o del:

T he fi nal test t o e ns ure t h at t he N u Vie w's attac h me nt t o t he e n d osc op e is s ufficie nt l y r o b ust

was perf or m e d usi n g a p orci ne c ol o n si m ulate d use e x peri me nt. T his e x peri me nt meas ure d

t he cli nicall y rele va nt f orces t h e d e vice w o ul d e x perie nce d uri n g i nserti o n a n d re m o val

fr o m t he c ol o n. We attac he d t he N u Vie w t o a n e n d osc o pe a n d t he n c o nti n u o usl y meas ure d

t he f orces t hat t he de vice face d d uri n g i nserti o n a n d re m o val fr o m t he p orci ne c ol o n b y

usi n g a l oa d cell c o n n ecte d t o t he gastr os c o pe d uri n g i nserti o n a n d re m o val i nt o t he p orci n e

c ol o n. T his e x peri me nt was re peate d 1 0 ti mes. T hr o u g h t his e x peri me nt, we meas ure d a

retracti o n f orce 2. 5 N +/ - 1 N. T his r etracti o n f orce d uri n g use is s u bsta ntiall y less t ha n t he

mi ni m u m N u Vie w detac h me nt f orce ( 7. 9 2 N) meas ure d i n Test 1, mea ni n g t he N u Vie w is

n ot li kel y t o detac h fr o m t he e n d osc o pe t hr o u g h t h e c o urse of a n or m al pr oce d ure.

Ris k s u m m ary: We h ave deter mi ne d t h at w hile det ac h me nt is a n i n here nt ris k t o all dist al

e n d osc o pe att ac h me nt ty pe devices s uc h as t he N u Vie w, t his ris k h as bee n miti g ate d t o a n

acce pt a ble l evel t hr o u g h t he i m ple me nte d ris k c o ntr ols a n d as s uc h d oes n ot p ose ser i o us ris k

t o t he he alt h, or welf are of t he s u bject.


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untitled h1
n o n -bi oc

All materials use d i n t he N u Vie w ar e bi oc o m pati ble. T he ris ks s urr o u n di n g bi oc o m pati bilit y f or me dical de vices ar e well u n derst o o d a n d t he F D A h as e xcelle nt bi oc o m pati bilit y g ui da nce d oc u me nts . Si milarl y, t here are rec o g ni ze d i nter n ati o nal sta n dar ds s urr o u n di n g bi oc o m pati bilit y s uc h as I S O 1 0 9 9 3- 1.  
We ha ve ta k e n t he ris k of bi oc o m pati bilit y i nt o acc o u nt i n t he de vel o p me nt of t he N u Vie w de vice.  
T he de vice is ma de fr o m 1 0 0 % bi oc o m pati ble materials f or piece of t he de vice. Bel o w is a list of all materials use d i n t he de vice, i ncl u di n g a n y a d hesi ves, 3 D resi ns, or ot h er materi als C ar b o n I nc.'s Sil 3 0 pri nt a ble resi n : T he press-fit c ollar will be ma de fr o m Car b o n In c.'s SI L 3 0 material w hic h is a s oft, bi oc o m pati ble, silic o n e uret ha ne elast o mer t hat has u n der g o ne I S O - 1 0 9 9 3 testi n g f or s ki n a n d m uc osal me m bra ne c o ntact. T he press -fit c ollar will be ma de fr o m t his s oft, elastic, silic o ne uret ha n e elast o mer i n or der t o s afel y i nter act wit h tiss ue d uri n g F A P. T his s oft silic o ne uret ha n e el ast o mer ( SI L 3 0) has u n der g o ne ri g or o us bi o c o m pati bilit y/sterilit y testi n g w hic h ma kes it i deal f or s h ort ter m m uc osal m e m bra ne c o ntact ( u p t o 2 4 h i n d urati o n). See A p pe n di x B f or a d diti o nal details relati n g t o bi oc o m pati bilit y a n d sterilit y.  
F or ml a bs's Me dic al Gr a de T o u g h 1 5 0 0 R esi n: T o u g h 1 5 0 0 material has bee n teste d t o I S O - 1 0 9 9 3 bi oc o m pati bilit y sta n dar d (see A p p e n di x B ). T his material c urre ntl y ma kes u p t he N u Vie w's b o d y a n d bac k b o ne. It is a n e x celle nt material f or t h e t his beca use of it's stiff, yet plia ble nat ure bei n g a ble t o be n d a n d s pri n g bac k q uic kl y t o its ori gi nal s ha pe. Si milarl y, t his material is c o m pati ble wit h a wi de ra n ge of c o m m o n sterilizati o n pr ocesses f or me dical de vices. F or m ore i nf or mati o n o n t his material, i ncl u di n g bi oc o m pati bilit y a n d sterilit y i nf or mati o n please refer t o A p pe n di x B .  
Mirr or: T he mirr or is ma de fr o m 1 m m -t hic k mirr ore d gl ass. T his c o m p o ne nt will be c ust o mma n ufact ur e d b y K ni g ht O ptical usi n g a scri bi n g pr ocess. U p o n d eli ver y t o E n d o T heia, t he mirr or will be clea ne d usi n g 9 9 % is o pr o p yl alc o h ol pri or t o asse m bl y.  
A d hesive i nf o : L octite 4 3 5 h u mi dit y -c ure d et h yl -base d a d hesi ve fr o m He n kel has bee n teste d t o I S O-1 0 9 9 3 bi o c o m pa bilit y sta n dar d (see A p pe n di x B ). T his a d hesi ve is use d t o faste n t he press -  
fitti n g feat ure wit h pr ojecti o ns a n d t he mirr or t o t he str uct ural b o d y of t h e N u Vie w. Si milarl y, t his a d hesi ve is c o m p ati ble wit h a wi de r a n ge of c o m m o n sterilizati o n pr ocess es f or m e dical d e vices, s uc h as c ol d sterila nts, et h yle ne o xi de, a n d ga m ma ra diati o n. F or m or e i nf or mati o n o n t his material, i ncl u di n g bi oc o m pat i bilit y a n d sterilit y i nf or mati o n please ref er t o A p pe n di x B .  
Ris k s u m m ary: We h ave deter mi ne d t h at bec a us e all m ateri als use d i n t he c o nstr ucti o n a n d all a d hesives use d d uri n g device asse m bly are bi oc o m p ati ble a n d h ave bee n teste d t o t he a p pr o pri ate I S O 1 0 9 9 3 st a n d ar d t h at t he ris ks ass oci ate d wit h bi oc o m p ati bility are acce pt a ble a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.
untitled h1
sterilit y r is k

Sterilizati o n ris ks are i n here nt t o all me dical de vices. B ot h t he ris ks ass ociate d wit h i nfecti o n w he n de vices ar e n ot sterilize d a n d t he ris ks ass ociate d wit h material pr o pert y de gra dati o n if a n i na p pr o priate sterilizati o n met h o d is c h ose n f or a gi ve n material. We ha ve ta ke n b ot h of t hes e p ote ntial ris k cate g ories i nt o acc o u nt d uri n g t he de vel o p me nt of t he N u Vie w de vice.  
We ha v e i ncl u de d i nf or mati o n i n A p pe n di x B wit h re gar ds t o sterilit y s h o wi n g h o w a n i n de p e n de nt sterilit y testi n g h o use ( S T E RI S) has verifie d t hat a ut ocla ve is a n a p pr o priate met h o d of sterilizati o n of b ot h of t he F or mla bs's resi ns we' ve us e d i n t he c o nstr ucti o n of t he de vice. Si milarl y, t he me dical gra de a d hesi v e we' v e use d d uri n g t he asse m bl y pr ocess has s h o w n t o be resilie nt u p t o te m perat ur es m uc h hi g her t ha n t h ose see n i n t he a ut ocla vi n g pr ocess a p pr o priate f or t he N u Vie w  
(A p pe n di x B f or data o n a d hesi ve). We ha v e als o verifie d t hat t his a d hesi ve mai ntai ns its pr o perties a n d f u ncti o nal str e n gt h s ufficie nt p ost sterilizati o n . All materials use d i n t he c o nstr ucti o n a n d asse m bl y are a p pr o priate materials f or o ur sel ecte d sterilizati o n pr ocess of a ut ocla vi n g a n d all of t he materials s h o w resilie nce t o t he a ut ocla vi n g sterilizati o n pr ocess. Please refer t o A p pe n di x B  
t o see t he r esilie nce of s electe d mat erial a n d t he a p pr o priate n ess of t he a ut ocla vi n g sterilizati o n pr ocess.  
Ris k s u m m ary: We h ave deter mi ne d t h at t he ris ks ass oci ate d wit h sterility a n d t he steriliz ati o n pr oc ess are c urre ntly acce pt a ble a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.
untitled h1
de vice bre a k

A n ot her ris k i n her e nt t o me dical de vices is t he ris k of de vice brea k a ges or fail ures. I n d ee d, a l ar g e part of t he de vel o p me nt pr ocess is ai me d at i de ntif yi n g a n d miti gati n g p ote ntial de vice brea k a ges a n d fail ure p oi nts. Lar g e eff orts are ma d e t o i de ntif y t hese p ossi ble brea k a ges t hr o u g h a s yste matic pr ocess s uc h as Fail ure M o des & Effects A n al ysis ( F M E A) a n d Fa ult Tr ee A nal ysis ( F T A). As part of o ur de v el o p me nt pr ocess, w e e m pl o y b ot h of t hese m et h o ds f or i de ntif yi n g p ote ntial de vice fail ures a n d br ea ka g es. A n ot her wa y de vi ce de v el o pers tr y t o i de ntif y p ote ntial fail ure m o des or li kel y brea ka ges is t o researc h w h at t he fail ures a n d brea ka g es are r e p orte d i n t he F D A's M A U D E  
data base f or ot her si milar t y pe de vices. We h a ve r e vie we d t his M A U D E data base dat a f or d e vice brea k a g es a n d fail ures f or de vices si milar t o t he N u Vie w (refer t o A p pe n di x A ) a n d t he n ta ke n t his i nf or mati o n i nt o acc o u nt d uri n g desi g n t o create ris k c o ntr ols t o pr e ve nt si milar t y pe of fail ures/ brea ka g es fr o m h a p pe ni ng d uri n g use of t h e N u Vie w d e vice.  
  
O ne of t he m ost c o m m o nl y see n de vice brea ka g es re p orte d i n t he M A U D E data bas e f or distal e n d osc o pe attac h me nt t y pe de vices is t hat of pr oj ecti o n brea k a ges. T hes e e n dca ps ha v e hairli ke pr ojecti o ns t hat ar e mea nt t o s m o ot h o ut t he m uc osal f ol ds a n d i ncreas e e n d osc o pe vis ualizati o n.  
T hese hairli ke pr oj ecti o ns ca n be see n i n t he fi g ur e bel o w. T hese pr ojecti o ns are i nte n de d t o f ol d bac k d uri n g e n d osc o pe i nserti o n a n d t he n t o fa n o ut war ds a n d i nteract wit h t he m uc osal tiss ue as y o u ge ntl y p ull t he e n d osc o pe bac k war ds. D uri n g t his i nteracti o n wit h t he m uc osal li ni n g, t he y b ot h s m o ot h t he f ol de d tiss ue a n d als o kee p t he tiss ue sli g htl y a wa y fr o m t he e n d osc o pe's ti p s o t hat t he tiss ue is at t he pr o per vie wi n g dista nce fr o m t he e n d osc o pe o ptic or vie wi n g le ns. T hese h airli ke pr ojecti o ns are als o pr o ne t o brea ki n g off fr o m t he de vice d ue t o t heir sli m pr ofile a n d pi n p oi nt c o n necti o ns t o t he b o d y of t he de vi ce. F or e xa m ple, t here were s e veral differe nt r e p orts of t his t y pe of de vice br ea ka g e re p orte d i n t he M A U D E data b as e f or t h e ar c E n d oc uff de vi ce  
(K 1 5 1 8 0 1 ). T he bel o w ta ble lists a fe w e x a m ples r e p orts f or h airli ke pr ojecti o n brea ka g es f or t h e Arc E n d oc uff a n d t h ere are li n ks wit hi n t he ta ble t o t he f ull re p orts.  
| T a bl e VII . M A U D E D at a (fr o m t h e F D A d at a b as e)  M A U D E D A T A: E x a m ple re p orts f o r h airli ke pr ojecti o n bre a k a ges   |                   |                                                   |                                                                                                   |                |            |    |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------|------------|----|
| De vice                                                                                                                                                     | D ate             | Pr o ble                                          | m                                                                                                 | Descri pti o n | H ar       | m  |
| K 1 5 1 8 0 1                                                                                                                                               | 1 2/ 0 9/ 2 0 1 5 | Detac h me nt                                     | of                                                                                                |                |            |    |
| de vice c o m p o n e nt                                                                                                                                    | N o h ar          | m t o t he                                        |                                                                                                   |                |            |    |
| p atie nt                                                                                                                                                   |                   |                                                   |                                                                                                   |                |            |    |
| K 1 5 1 8 0 1                                                                                                                                               | 7/ 2 3/ 2 0 1 5   | Brea k; detac h me nt  of de vice c o m p o ne nt | De v ice detac h es fr o m t h e  e n d osc o pe  De vice detac h es fr o m t h e  e n d osc o pe | N o h ar       | m t o t he |    |
| p atie nt                                                                                                                                                   |                   |                                                   |                                                                                                   |                |            |    |  
  
We ha ve ta ke n t his M U A D E brea ka g e data i nt o acc o u nt d uri n g t he desi g n a n d de vel o p me nt of t he N u Vie w de vice b y creati n g a ris k c o ntr ol t hat e ns ures re d u n da n c y t hr o u g h t he desi g n of t he pr ojecti o ns t he msel ves. T his ris k c o ntr ol is a n a d de d safet y l o o p (see n i n t he pict ur e bel o w)  
c o n necti n g eac h hairli ke pr ojecti o n s o t hat eac h i n di vi d ual hair is n o l o n ger a ble t o detac h t hr o u g h a si n gle brea ka ge. I nstea d, n o w t here n ee ds t o be at least t w o brea ka g es f or a n y o ne pr oject t o brea k off fr o m t he de vice a n d i n s o me cases t w o brea ka g es will still n ot be s ufficie nt t o disl o d ge a pr ojecti o n. Si milar l y, a n ot her ris k c o ntr ol was t o desi g n o ut t he t hi n pi n-j oi nt fail ure z o ne w hic h we belie ve c o ntri b ute d t o se veral of t he brea ka g es of t he Arc E n d oc uff de vice a n d i nstea d us a  
```
m ore r o b ust a n d lar g er j oi nt of m ol de d fle xi ble material.

We h a ve als o c o n d u cte d verificati o n tests r elate d t o t he f orces r e q uire d t o brea k t hese ar m-li ke

pr ojecti o ns t o gai n c o nfi de nce i n t he de vice's r o b ust ness. T he f oll o wi n g gi ve e xa m ples of h o w

str o n g t hese ar m-li ke pr ojecti o ns are a n d t he n we c o m pare t his stre n gt h t o a n ot her F D A a p pr o ve d

de vice t o gai n c o nfi de n ce t hat t h e N u Vi e w d e vice is s ufficie nt at r esisti n g t his t y pe of de vi ce

brea ka g e.

a. Stre n gt h of Vis u al E n h a nce me nt we b att ac h me nt:

W e ha v e c h aracterize d t he f orce re q uire d t o detac h t he N u Vi e w ar m-li ke pr ojecti o ns

(called t he Vis ual E n ha n ce me nt w e b ). T h e detac h me nt f orce was meas ur e d b y pr o p erl y

affi xi n g t he N u Vie w de vice t o a s mall cla m p m o u nte d t o t he b ott o m of a f orce ga u g e a n d

gra b bi n g i n di vi d ual we b pr ojecti o ns usi n g a n ot her cla m p attac he d t o t he le ver ar m of t he

cali brate d f orce ga u ge. T he test set u p f or t his e x peri me nt ca n be s ee n i n t he fi g ure bel o w.

T he safet y l o o p o n t he N u Vie w de vice wer e c ut t o all o w f or t he meas ure me nt of t he

i n di vi d ual we b detac h me nt f orces . T h e t o p cla m p was o pe ne d a n d t he first pr ojecti o n was

i nserte d a n d t he cla m p w as s h ut. T he le ver was l o were d a n d t he N u Vi e w d e vice itself was

attac he d t o t he m o u nte d cla m p o n t he b ott o m of t he f orce ga u g e. T he f orce o n t he f orce

ga u ge was set t o pea k te nsi o n a n d zer oe d. T he cla m p was sl o wl y p ulle d u p war ds u ntil t he


```  
  
pr ojecti o n beca me f ull y detac he d. T h at detac h me nt f orce was rec or d e d a n d t he e ntire test set u p was re peate d f or all ei g ht N u Vie w pr ojecti o ns. T hr o u g h t hese tests it was f o u n d t hat a n a ver a ge detac h me nt f orce of 8. 3 N a n d mi ni m u m detac h me nt f orce of 6. 6 N was re q uire d t o f ull y detac h t he vis ual e n ha nce me nt w e bs.  
T his detac h me nt f orce gr eatl y e xcee ds t he e x pecte d f orces o n t he N u Vie w w he n de pl o ye d i n t he patie nt, gi vi n g c o nfi de nce t hat t he de vice will n ot u ni nte nti o nall y l ose a n y we b pr ojecti o ns d uri n g t he p r oce d ure. A d diti o nall y, 5 of t he pr ojecti o ns are e q ui p pe d wit h a safet y l o o p, i ncreasi n g t he f orce nee de d t o f ull y detac h t h ose secti o ns d uri n g a pr oce d ure.  
N o de vice fail ur es or br ea ka g es wer e o bser ve d i n t hese e x peri me nts. D uri n g a n act ual pr oce d ur e, w e d o n ot e x p ect t he w e b be d p orti o ns of t he vis ual e n h a nce m e nt we b t o bec o m e de tac he d fr o m eac h ot her. T his data gi v es c o nfi de nce t hat t h e e n d os c o pe attac h me nt pr ess fitti n g is m ore t ha n s ufficie ntl y r o b ust.  
| T a bl e 8 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e N u Vi e w Vis u al E n h a n c e m e nt w e b   |                        |                  |        |     |               |
|----------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------|--------|-----|---------------|
| De vice                                                                                                                          | A ver a ge F orce [ N] | Mi n F orce [ N] |        | M a | x F orce [ N] |
| 1                                                                                                                                | 8. 6                   | 6. 6             | 1 1. 0 |     |               |
| 2                                                                                                                                | 8. 0                   | 7. 6             | 8. 4   |     |               |
| 3                                                                                                                                | 8. 8                   | 8. 4             | 9. 0   |     |               |
| 4                                                                                                                                | 7. 8                   | 7. 4             | 8. 0   |     |               |
| Over all aver a g e:                                                                                                             | 8. 3                   | 6. 6             | 8. 0   |     |               |  
b. C o m p ari n g Vis u al E n h a nce me nt we b det ac h me nt f orces t o a n F D A a p pr ove d device:  
We ha v e c o m pare d t he f orce re q uir e d t o det ac h t he Vis ual E n h a nce m e nt We b fr o m t he N u Vie w t o a n F D A a p pr o ve d distal e n d osc o pe attac h me nt de vice si milar t o t he N u Vie w, calle d t he Arc E n d oc uff. T his is t o e ns ure t hat t he Vis ual E n ha nce me nt we b is at least as safe fr o m det ac h me nt e v e nts as t he o nes prese nt o n t he Arc E n d oc uff. T he detac h me nt f orce was meas ure d b y attac hi n g t he Arc E n d oc uff t o a cla m p a n d p ulli n g t he pr ojecti o ns off i n di vi d uall y usi n g a cali brate d f or ce ga u g e si milar t o h o w t he N u Vie w detac h me nt f orces were c haracterize d. T hr o u g h t hese tests, it was f o u n d t hat a n a vera ge detac h me nt  
| T a bl e 9 . S u m m ar y of t h e f or c es r e q uir e d t o d et a c h t h e Ar c E n d o c uff Vis u al E n h a n c e m e nt w e b  De vice A ver a ge F orce [ N] Mi n F orce [ N] M a x F orce [ N]  1 7. 8 6. 2 9. 0  2 8. 9 7. 4 1 1. 0  3 8. 4 7. 2 1 1. 0  4 8. 9 7. 8 1 1. 4  5 8. 7 7. 4 1 1. 0  Over all aver a g e: 8. 5 6. 2 1 1. 0   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
f orce of 8. 5 N a n d mi ni m u m f orce of 6. 2 0 N is r e q uire d t o f ull y detac h t h e Arc E n d oc uff fr o m t he e n d osc o p e. A s u m mar y of t he f orces re q uire d t o re m o ve t h e Ar c E n d oc uff fr o m t he e n d osc o pe ca n be s ee n i n Ta ble I X.  
E ac h of t h e ar m li ke pr ojecti o ns t hat ma ke u p t h e N u Vie w's e n ha n ce me nt we b a p pear t o be as r o b ust as eac h of t he ar m-li ke pr ojecti o ns of t h e F D A a p pr o ve d c o m paris o n de vice. T he N u Vi e w has als o i ncl u de d a saf et y l o o p t hat a d ds re d u n da nce i nt o t hese ar m -li ke pr ojecti o ns w hic h mea ns t hat n o si n gle fail ure ca n ca use t h e pr ojecti o n t o tear off. T he F D A c o m paris o n de vice d o es n ot ha ve t his re d u n da n c y a n d yet is still c o nsi dere d saf e.  
Ris k S u m m ary: B ase d o n o ur revie w of t he M A U D E d at a b ase f or device bre a k a ges a n d f ail ures of si mil ar ty pe device t o t he N u Vie w a n d o ur pr o p ose d ris k c o ntr ols t o miti g ate t hese k n o w n bre a k a ges, as well as o ur verific ati o n testi n g t o e ns ure t he N u Vie w's r o b ust ness, we h ave deter mi ne d t h at t he ris ks ass oci ate d wit h device f ail ures a n d bre a k a ges are c urre ntly acce pt a ble a n d d o n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.
untitled h1
bl oc ki n g

Wit h a n y distal e n d osc o pe attac h me nt t y pe d e v ice t here is a ris k of bl oc ki n g f u ncti o nalit y of t he e n d osc o pe if t he de vice is p o orl y desi g ne d. F or i nsta nce, it w o ul d be eas y t o c o ver t he fr o nt f ace of t he e n d osc o pe a n d bl oc k t he irri gati o n or s ucti o n c ha n nel if t he de vice was desi g ne d i n s uc h a wa y t h at its mec ha nical press fitti n g c o v ere d t he fr o nt s urface of t he e n d osc o pe or h a d s o me ot her feat ur e w hic h bl oc ke d t he s ucti o n or irri gati o n c ha n nel. We ha ve ta ke n t his ris k i nt o acc o u nt d uri n g t he desi g n of t he N u Vie w a n d t he f oll o wi n g are ris k c o ntr ols w hic h will pre ve nt o ur d e vice fr o m  
```
bl oc ki n g f u ncti o nalit y of t he e n d osc o pe:

1. T he press fitti n g attac h me nt feat ur e w as desi g n s uc h t hat it will o nl y c o me i nt o c o ntact

wit h t he si de pr ofile of t he e n d osc o pe a n d will sta y sec urel y i n place wit h o ut c o veri n g t he

fr o nt face of t he e n d os c o pe w her e t he s u cti o n, i ns ufflati o n a n d irri g ati o n c ha n nels are

l ocate d. We h a ve c o nfir me d t hat s ucti o n, i ns ufflati o n a n d irri gati o n w or k n or mall y w hile

t he N u Vie w is attac h e d t o t he e n d osc o pe.

2. T he e n d ca p d esi g n offs ets t he mirr or fr o m t he fr o nt face of t he e n d osc o pe b y > 5 m m,

lea vi n g s ufficie nt s pace f or s ucti o n, i ns ufflati o n, a n d irri gati o n t o e nter t he s ur gical fiel d.

F urt her, a mi ni mal li p is desi g ne d i nt o t he e n dca p t hat e xte n ds n o m ore t ha n 1 m m i nt o t he

fr o nt face of t he e n d osc o pe, lea vi n g t he o bjecti v e le ns, ill u mi nati o n, w or ki n g c ha n nels,

a u xiliar y water p ort, a n d le ns clea ni n g p ort u n o bstr ucte d. We ha ve c o nfir m e d t hat s ucti o n,

i ns ufflati o n a n d irri gati o n w or k n or mall y w hile t h e N u Vie w is attac he d t o t he e n d osc o pe.

3. We h a ve i nc or p orat e d a 1. 7 5 m m d rai n a ge h ol e i nt o t he de vice d esi g n l ocate d o n t h e

str uct ural bac k b o ne of t h e N u Vie w t o e n a ble fl ui d drai ni n g. I n a d diti o n, t he s pace o p p osite

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t he N u Vie w mirr or is left f ull y o pe n as s h o w n i n Fi g ure 1 pr o m oti n g f urt her drai na ge.  
Ris k S u m m ary: We h ave deter mi ne d t h at t he ris ks ass oci ate d wit h irri g ati o n/s ucti o n h ave bee n miti g ate d t o a n acce pt a ble level t hr o u g h t he i m ple me nte d ris k c o ntr ols a n d as s uc h d oes n ot p ose seri o us ris k t o t he he alt h, or welf are of t he s u bject.  
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Tiss ue tr a u m a r is k miti g ati o n s:

Tiss ue tra u ma is i n here nt t o all e n d osc o pic pr o ce d ures. S pecific t o t he N u Vie w de vice , t he m ost

li kel y ris ks of tiss ue tra u ma are d uri n g i nserti o n a n d re m o val of t he e n d osc o pe. We ha v e ta ke n t his

ris k i nt o acc o u nt w he n desi g ni n g t he N u Vie w de vice a n d ha v e a d de d ris k c o ntr ol feat ures t o

mi ni mize t he li keli h o o d of t his ris k . T he f oll o wi n g are ris k c o ntr ol meas ur es were a d de d t o re d u ce

t he ris k of tra u ma t o tiss ue t o a n acce pta ble l e vel:

a. We ha ve desi g ne d t he N u Vie w usi n g a r o u n de d bi oc o m pati ble material t hat is e q ual t o or

l o wer d ur o meter t ha n t h e fr o nt face of t he m ost e n d osc o pes a n d t his s h o ul d re d uce t he

p ote ntial f or tra u ma t o t h e patie nt tiss ue

b. We ha ve i ncl u d e d a n atra u matic i nserti o n ti p t hat is desi g ne d f or eas y i nserti o n a n d is ma de

fr o m a s m o ot h, n o n-a brasi ve material t o r e d uce f orces place d o n tiss ue d uri n g i nserti o n

a n d na vi gati o n.

c. We h a ve r o u n de d all e x p ose d e d g es d uri n g i n acc or da n ce wit h H E 7 5 h u ma n f act ors

sta n dar d t o facilitate less tra u ma a n d gi ve c o nfi de nce t hat t he de vice is atra u matic o n

i nserti o n a n d na vi gati o n.

d. We ha ve als o teste d t he N u Vie w i n a p orci ne c ol o n m o del, w here we i nte nti o nall y i nserte d

a n d re m o ve d 2 of t he de vices 5 x ti mes eac h a n d t he n perf or me d a vis ual i ns pecti o n a n d a

s u b mersi o n test t o i ns pect t he c ol o n f or a n y s ustai ne d tra u m a or perf oratio n. T her e w as n o

o bser va ble tiss ue da m a ge i n a n y of t hese e x p eri me nts.

e. We ha ve acc o u nte d f or ma xi m u m i nserti o n wi dt h i n acc or da nce wit h t he i nter nati o nal

e n d osc o pe sta n d ar d I S O 8 6 0 0 f or ma xi mal all o wa ble i nserti o n wi dt h. Si milarl y, t he

ma xi m u m ri gi d wi d t h of t he e n d osc o p e a n d t he N u Vie w as meas ure d w hile t he N u Vie w is

attac he d is 1 6 m m , w hic h is less t ha n ot her a p pr o ve d e n d osc o pes c urre ntl y o n t he mar ket

w hic h are c o nsi der e d saf e t o i nsert i nt o t he patie nt.

Ris k S u m m ary: We h ave deter mi ne d t h at w hile tiss ue tr a u m a is a n i n here nt ris k t o all dist al

e n d osc o pe att ac h me nt ty pe devices s uc h as t he N u Vie w, t his ris k h as bee n miti g ate d t o a n

acce pt a ble l evel t hr o u g h t he i m ple me nte d ris k c o ntr ols a n d as s uc h d oes n ot p ose seri o us ris k

t o t he he alt h, or welf are of t he s u bject.


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4. 2 j ustific ati

T he g oal of t his earl y feasi bilit y st u d y is t o de m o nstrate t h at t he pa pilla ca n be vis ualize d usi n g a f or war d faci n g gastr osc o pe e q ui p pe d wit h t he N u Vie w, e na bli n g F A P patie nts t o u n der g o t heir yearl y r o uti ne e n d os c o pi c e x a m wit h o ut t he us e of a d u o de n os c o pe. We h y p ot hesize t hat t he mi ni mall y i n vasi ve e n d osc o pic pr oce d ure ma y offer t he f oll o wi n g be n efits: ( 1) re d uce d i nfecti o n rates d ue t o t he eli mi nati o n of t he n ee d f or a d u o d e n osc o pe, ( 2) s h orter pr o ce d ure ti me i ncl u di n g s h orter ge neral a nest h esia ti me d ue t o n ot nee di n g t o s witc h sc o pes mi d pr oce d ur e a n d r e d uci n g t he t otal n u m ber of sc o pes use d i n t he pr oce d ure, a n d ( 3) p ote ntiall y less tra u ma t o patie nt tiss ue d ue t o t he atra u matic feat ures of t he N u Vie w a n d d ue t o o nl y nee di n g t o i nsert a n d re m o ve o ne e n d osc o pe c o m par e d t o t w o differe nt i nserti o ns wit h t w o differ e nt sc o pes. T his earl y feasi bilit y st u d y will f oc us o n t he a d va nta ges of t he n e w tec h n ol o g y t o t he patie nt. A d va nta g es t o t he healt hcar e s y ste m will be e xa mi ne d d uri n g f ut ur e st u dies.
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4. 3 descri pti o

T he patie nt p o p ulati o n f or t his st u d y are fa milial a de n o mat o us p ol y p osis ( F A P) patie nts. F A P is ca use d b y pat h o ge nic ger mli ne varia nts i n t he A P C t u m or -s u p press or ge ne a n d is c onsi dere d a here ditar y ca n cer s y n dr o me. I n di vi d uals wit h F A P de vel o p h u n dre ds t o t h o usa n ds of c ol or ectal a de n o mas, w hic h us uall y arise d uri n g a d olesce nce or earl y a d ult h o o d. O nce t he dia g n osis of F A P  
is ma de, m ost of t he atte nti o n te n ds t o f oc us o n ma na ge me nt of p ol y ps wit hi n t he c ol o n a n d u p per GI tract . Data fr o m hist orical F A P c o h orts esti mate d t he lifeti me ris k of i ntesti nal ca ncer t o be 9 0 % t o 1 0 0 % f or affecte d i n di vi d uals a n d a d va nces i n earl y detecti o n a n d pr o p h ylactic s ur ger y ar e c urre ntl y t he d efi niti ve t hera p y f or pre v e nti n g ca n cer f or mati o n i n F A P patie nts .  
D u o de nal a n d a m p ullar y ca ncers are a lea di n g ca use of ca ncer d eat h f or i n di vi d uals wit h F A P .  
T he c u m ulati ve ris k of u p per GI ca n cers is c orr elate d wit h t he n u m ber, size, a n d hist ol o g y of d u o de nal p ol y ps ( assess e d b y S pi gel ma n et al sta ges 0– I V). Ma n a ge m e nt g ui deli nes f or F A P  
iss ue d b y gastr oe nter ol o g y a n d s ur gical pr of essi o nal s ocieties stress t he i m p orta nce of lifel o n g caref ul s ur veilla nce of t h e st o mac h, d u o de n u m, a n d pa pilla 8, 9, 1 0, 1 1 I n t his earl y f easi bilit y st u d y 3 a d ult s u bjects, 1 8 t o 7 0 years of a g e, will be st u die d. S u bjects will be recr uite d fr o m t he Gastr oe nter ol o g y cli nic at V a n der bilt U ni versit y Me di cal Ce nter a n d m ust q ualif y e n d osc o pic e xa mi nati o n of t he pa pilla. Me n a n d w o me n of a n y et h nicit y, race or s oci oec o n o mic stat us wit h F A P w h o meet i ncl usi o n criteria will be off er e d e nr oll me nt i nt o t he st u d y. S u bjects will be scree n e d t o e ns ur e t hat t h e y d o n ot ha ve a n y u n d erl yi n g c o m or bi dities or ot her c o nsi der ati o ns t hat w o ul d precl u de t h e us e of t h e i n vesti gati o nal de vi ce.
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5. description of the procedure

As detaile d bel o w a n d i n Fi g ure 6 , t he c o m p o ne nts in Ta ble I are use d p erf or m t he yearl y r o uti ne e n d osc o pic e xa mi nati o n of F A P patie nts. T he o nl y i n vesti gati o nal ste p is w h e n t he N u Vie w de vice is attac he d o n t he e n d osc o pe a n d use d t o vis ualize t he pa pilla. T h ere is n o t h era p y deli ver e d d uri n g t his pr oce d ure a n d t he o nl y pri mar y e n d p oi nt i n t his feasi bilit y st u d y is t o s uccessf ull y vis ualize  
t he pa pilla usi n g t he N u Vie w.  
5. 1 S T E P 1: O btai n Patie nt C o nse nt. T he p ot e ntial partici pa nt will be pr o vi de d wit h a c o p y of t he c o nse nt f or m t o r ea d a n d will be pr o vi de d wit h a n o p p ort u nit y t o as k q u esti o ns. O nce t he st u d y partici pa nt's q uesti o ns ha ve bee n a ns w ere d a n d pri or t o perf or mi n g a n y st u d y -relate d pr oce d ur e, a n I R B -a p pr o ve d c o ns e nt f or m will be si g ne d a n d date d b y t h e st u d y partici pa nt a n d b y t he pers o n o btai ni n g i nf or me d c o nse nt. A c o p y of t he si g ne d c o nse nt f or m will be pr o vi de d t o t he s u bject a n d t he i nf or me d c o nse nt pr ocess will be d oc u m e nte d i n t he st u d y partici pa nt's me dical rec or d.  
5. 2 S T E P 2: Re vie w I ncl usi o n / E xcl usi o n Criteria. Pri or t o t he st u d y, w he n a p ote ntial ca n di date is i de ntifie d, a re vie w of t he i ncl usi o n/e xcl usi o n criteria will be perf or m e d. Na mel y, t he patie nt m ust be: (1) bet w ee n t he a g es of 1 8 t o 7 0 years ol d, a n d (2) m ust be a ble t o pr o vi de writ te n i nf or me d c o nse nt. Si milarl y, t he ca n di d ate m ust n ot be: (1) c urr e ntl y pre g na nt, a n d  
( 2) ca n n ot b e c urre ntl y dia g n ose d or bei n g tr eate d f or ca n cer.  
5. 3 S T E P 3: Re vie w Me dical Hist or y. I n li ne wit h sta n dar d cli nical practice, t he patie nt's me dical hist or y will be r e vie we d bef ore t he pr oce d ure t o e ns ure t he ca n di d ate d o es n ot ha ve a n y ite ms t hat w o ul d precl u de t he m fr o m bei n g a g o o d ca n di date f or t he pr oce d ure.  
5. 4 S T E P 4: R o ut i ne Pre g na nc y Test (fe male p artici p a nts). A n y i de ntifie d ca n di date t hat is fe male will ha ve a r o uti ne pre g na nc y test pri or t o t he pr oce d ure as part of t he i ncl usi o n/e xcl usi o n criteria.  
T h ose partici pa nts w h o are c o nfir me d t o be pre g na nt will be e xcl u d e d fr o m t he st u d y.  
5. 5 S T E P 5: Gast r osc o pe e n d osc o pic assess me nt. Usi n g a sta n dar d gastr osc o pe, t he Ol y m p us GI F -H 1 9 0 , t he s ur ge o n will i ntr o d uce t he sc o p e i nt o t he p atie nt t o ass ess t he es o p h a g us, st o mac h, a n d d u o de n u m f or p ol y ps. T his will be perf or me d p er t he sta n d ar d of care wit h o ut de viati o n fr o m t he c urre nt cli nical practice d uri n g t he yearl y r o uti ne e n d osc o pic e xa mi nati o ns f or F A P patie nts.  
5. 6 S T E P 6: E n d osc o pic vis ualizati o n of t he pa pilla usi n g t he N u Vie w (i nvesti g ati o n al ste p).  
O nce t he s ur ge o n has c o m plete d t he i nitial assess me nt usi n g a gastr osc o pe t he N u Vie w de vice will be attac he d t o t he gastr osc o pe a n d i ntr o d uce d i nt o t he patie nt. T h e de vice will be na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d. E xact se q ue ntial pr ot oc ol f or t his ste p is as f oll o ws:  
a. T he N u Vie w's sterile pac ka gi n g will be i ns pecte d a n d c o nfir me d i ntact.  
b. T he N u Vie w's pac k a gi n g will be o pe ne d.  
c. T he N u Vi e w will b e att ac he d t o t he g astr osc o pe a n d t he fitti n g a n d attac h me nt will be c o nfir me d t o be sec ur e.  
d. T he gastr osc o pe e q ui p pe d wit h t he N u Vie w will be i nserte d i nt o t he patie nt i n t he sta n dar d e n d osc o pic f as hi o n.  
e. T he gastr osc o pe will be na vi gate d t o t he d u o de n u m a n d t he pa pilla will be vis ualize d usi n g t he N u Vie w.  
f. T he gastr osc o p e a n d de vi ce will be re m o v e d fr o m t he patie nt.
T his is t he i n vesti gati o nal ste p of t he pr ot oc ol. All s u bse q ue nt ste ps will be perf or me d p er t he  
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stan dar d of car e as t he y are us uall y perf or me d f or r o uti ne e n d o sc o pic F A P e xa mi nati o ns.

5. 7 S T E P 7: C o nfir mati o n usi n g a sta n dar d d u o de n os c o pe . T he s ur ge o n will t he n c o nfir m pa pilla

vis ualizati o n usi n g a sec o n dar y met h o d w hic h is cli nicall y acce pte d. T his will be ac hie ve d b y

i nserti n g a sta n dar d d u o de n osc o pe, t h e Ol y m p us TJ F-Q 1 8 0 V, t o vis ualize t he pa pilla. T his

will e ns ure t hat a n yt hi n g n ot vis ualize d wit h t he N u Vie w will be see n usi n g a sta n dar d

cli nicall y acce pt e d met h o d. F urt her a n yt hi n g t hat was vis ualize d b y t he N u Vie w will a gai n be

vis ualize d usi n g a sec o n d cli nicall y-acce pt e d sta n dar d met h o d. T he i nserti o n a n d assess me nt

wit h t he D u o de n osc o pe will be perf or me d per t h e sta n dar d of care , usi n g t he sta n dar d pr ot oc ol

f or F A P patie nts d uri n g r o uti ne yearl y e n d osc o pi c e xa mi nati o ns. T he s ur ge o n will i nsert a

d u o de n osc o pe i nt o t he patie nt a n d na vi gat e t o t he d u o de n u m. T he p a pilla will be i ns pecte d t o

c o nfir m w hat was vis ualiz e d usi n g t he N u Vie w de vice. T his is a pr otecti o n i n li ne wit h w hat

is o utli ne d i n 2 1 C F R 8 1 2, w hic h states t hat a n y dia g n ostic N S R de vice m ust ha ve a

c o nfir mati o n of di a g n osis usi n g a sec o n d cli nicall y acce pte d met h o d. O n ce t he pa pilla h as

bee n vis ualize d usi n g t he d u o de n osc o pe, t he sc o pe will be re m o ve d fr o m t he patie nt i n t he

sta n dar d cli nical met h o d.

5. 8 S T E P 8: Re vie w of a d verse e v e nts. I n li ne wit h sta n dar d cli nical pr actice, patie nts will be

cl osel y m o nit ore d d uri n g t he pr oce d ure a n d i n a r ec o ver y -r o o m s etti n g f oll o wi n g t he

pr oce d ur e. All a vaila ble cli nical data, i ncl u di n g e xa m fi n di n gs, a n d cli nical i m pressi o ns, will

be m o nit ore d. T he i n vesti gat or will e val uate a n y c h a n ges i n p h ysical stat us a n d will deter mi ne

if t he c ha n ge is cli nicall y i m p orta nt a n d differe nt fr o m w hat is a ntici pate d i n t he c o urse of

treat me nt. Si milarl y, t he i n vesti gat or a n d s u b-i n vesti gat ors will assess o n a r o uti ne basis if

a n y a d vers e e ve nts occ ur d uri n g t he st u d y at a n y p oi nt. All a d verse e ve nts/c o m plicati o ns t hat

occ ur d uri n g t he st u d y w het her de vice r elate d or n ot will be re p orte d a n d rec or de d.

5. 9 S T E P 9: P o st-e n d osc o p y s ur ge o n N A S A i n de x / q uesti o n naire. F oll o wi n g t he pr o ce d ur e, a

s h ort N A S A tas k l oa d i n de x / q u esti o n naire will be gi ve n t o t he s ur ge o n t o e x pl ore vari o us

ite ms of i nterest relate d t o t he usea bilit y of t he de vice s uc h as me ntal de ma n d, p h ysical de ma n d,

eff ort, fr ustrati o n, etc. ( A p pe n di x D)


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6. m o ni t

As t he Pri nci pal I n v esti gat or ( PI) of t his earl y feasi bilit y st u d y, Dr. Keit h O bstei n will be res p o nsi ble f or o vers eei n g t he safet y of t his trial o n a dail y basis. Cli nical data will be re vie we d dail y f or a d v erse e v e nts. I n a d diti o n, Dr. O bstei n is a vaila ble t o t he s u b- i n vesti gat ors, researc h staff, a n d be dsi de n urses, w h o will be m o nit ori n g partici pa nts f or a d v erse e ve nts. All u na ntici pate d a d verse de vice effects will be pr o m ptl y e val uate d a n d re p orte d as per pr ot oc ol i n Secti o n 3. 6. 1. 2 . Dr. O bstei n ma y pa use t he t rial t o i n vesti gate p ossi ble safet y relate d iss ues a n d/ or s u b mit c ha n ges t o t he st u d y desi g n t o a d dress a n y safet y-r elate d c o n cer ns a n d ma y disc o nti n ue t he trial s h o ul d ris ks t o partici pa nts be c o nsi der e d u nacce pta ble.  
S h o ul d it be disc o vere d t hat a s u b -i nvesti gat or is n ot i n c o m plia nce wit h t he si g ne d a gree me nt, t h e a p pr o ve d i n vesti gati o nal pla n, or a n y I R B r e q uire me nts f or t he c o n d ucti o n of t his st u d y, Dr.  
O bstei n will pr o m ptl y sec ure c o m plia nce or t he s u b- i n vesti gat or will be re m o ve d fr o m t he st u d y.
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6. 1 writ te n

Dr. O bstei n will perf or m re vie ws a n d/ or acc or di n g t o t he f oll o wi n g se q ue ntial sc he d ule:  
After t he first patie nt u n der g oes t he researc h pr ot o c ol.  
At a n y p oi nt i n w hic h a n a d verse e v e nt is e nc o u ntere d a n d/ or at a n y ti me w here t he ris k/ be nefit of t he researc h c ha n ges.  
At a n y p oi nt at w hic h a c o m plai nt of a researc h partici pa nt is recei ve d t hat ca n n ot be res ol ve d b y t he pri nci pal i n vesti gat or ( PI) a n d/ or r esear c h c o or di nat or ( R C).  
Eac h re vie w w ill res ult i n a writte n re p ort s u m marizi n g t he m o nit ors fi n di n gs.
7. L A B E LI N G  
Va n d er bilt U ni v ersit y Me dical Ce nter Di g esti v e Diseases Ce nter 1 3 0 1 Me dical Ce nter , Dr s uite 1 6 6 0 Nas h ville, T N 3 7 2 3 2 P h o n e: ( T B D) X X X -X X X X  
  
  
Ca uti o nar y State me nt: De vice o nl y t o be use d u n der t he directi o n of t he  
  
i n vesti gat ors of Va n der bilt I R B a p pr o val n u m ber T B D \# .
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8. c o n s

I nf or me d c o nse nt will be o btai ne d pri or t o t he st u d y. Please see A p pe n di x E f or i nf or me d re g ar di n g i nf or me d c o nse nt d oc u m e ntati o n.
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9. i r b i

T he st u d y will be s u b mitte d i n sta n dar d fas hi o n via t he V U M C H u ma n Researc h Pr otecti o ns Pr o gra m o nli ne platf or m a n d assi g ne d t o t he I R B Healt h Scie nces C o m mittee C hair f or assi g n me nt a n d re vie w.  
Va n der bilt H u ma n Researc h Pr otecti o n Pr o gra m Healt h Scie nces C o m mittee 1 3 1 3 2 1 st A ve. S.  
5 0 4 O xf or d H o use Nas h ville, T N 3 7 2 3 2- 4 3 1 5
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1 0. o t h

Va n der bilt U ni versit y Me dical Ce nt er is t he o nl y i nstit utio n partici pati n g i n t his earl y feasi bilit y st u d y.  
4 4
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1 1. a d di

C o m plete a n d acc urate r ec or ds will be ke pt d uri n g t he i n vesti gati o n a n d f or a peri o d of 2 years after eit her t h e date o n w hic h t he i n vesti gati o n is ter mi nate d or c o m plete d or t he dat e t hat rec or ds are n o l o n ger r e q uire d i n s u p p ort of an F D A mar ket a p plicati o n . Rec or ds will i ncl u de all c orres p o n d e nce r ele va nt t o t he i n vesti gati o n, I R B a p pr o ve d st u d y d oc u me nts, de vice acc o u nta bilit y rec or ds, s o urce a n d case re p ort f or m d oc u m e ntati o n, t o i n cl u de si g n e d c o nse nt d oc u me ntati o n a n d a n y a d verse e v e nt re p orts f or a n y partici pa nt.
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1 2. m a n

T he N u Vie w c o nsists of t hree c o m p o ne nts t hat are ma n ufact ure d i n de pe n de ntl y usi n g bi oc o m pati ble materials: t he str uct ural s u p p ort, mirr or, a n d press -fit c ollar. T hese c o m p o ne nts are s h o w n i n Fi g ure 7 , b el o w. T his secti o n details t he ma n ufact uri n g pla n f or eac h c o m p o ne nt, as well as t he asse m bl y a n d sterilizati o n pr ocesses f or t he c o m plete d N u Vie w d e vice.  
Str uct ur al S u p p ort: t he str uct ural s u p p ort c o m p o ne nt will be m a n ufact ure d usi n g a F or mla bs F or m 3 3 D pri nter ( S o mer ville, M A). T h e F or m 3 is a ster e olit h o gra p h y ( S L A) 3 D pri nter, w hic h uses a U V laser t o c ure li q ui d material resi ns la yer - b y-la yer o n a de dicate d b uil d tra y. M ore i nf or mati o n o n t he F or m 3 ca n be f o u n d at htt ps://f or mla bs.c o m/ 3 d -pri nters/f or m - 3/. T his c o m p o ne nt is 3 D pri nte d usi n g F or mla bs T o u g h 1 5 0 0 Resi n, a resilie nt material desi g ne d f or stiff a n d plia ble parts wit h si milar stre n gt h a n d stiff ness t o p ol y pr o p yle ne. T o u g h 1 5 0 0 Resi n is a me dical -gr a de, bi oc o m p ati ble material t hat is certifie d f or p er ma n e nt s ki n c o ntact. After pri nti n g, the str uct ural s u p p ort c o m p o ne nt will be clea n e d i n 9 9 % is o pr o p yl alc o h ol usi n g t he rec o m me n d e d F or m Was h s etti n gs a n d t he n c ure d t o f ull stre n gt h usi n g t he rec o m me n de d F or m C ure te m perat ur e pr ofile. F oll o wi n g t he c uri n g pr ocess, e x cess material fr o m t he 3 D pri nti n g pr ocess (i.e., s u p p ort material) will be re m o ve d wit h si de -c utti n g pliers a n d t he s u p p ort l ocati o ns will be fi nis he d wit h sa n d pa per f or a s m o ot h, u nif or m s urface fi nis h.  
Mirr or: T he mirr or is m a de fr o m 1 m m -t hic k mirr ore d glass (a b or osilicat e su bstrate wit h a t hi n e n ha nce d al u mi n u m mirr or c oati n g). T his c o m p o ne nt will be c ust o m -ma n ufact ure d b y K ni g ht O ptical usi n g a scri bi n g pr ocess. U p o n deli ver y t o E n d o T heia, t he mirr or will be clea ne d usi n g 9 9 % is o pr o p yl alc o h ol pri or t o asse m bl y.  
Press -Fit C oll ar: t he pr ess -fit c ollar is desi g ne d t o be s oft a n d elastic i n or der t o s afel y i nteract wit h tiss ue d uri n g F A P, as well as t o fit ti g htl y o n t he ti p of t h e e n d os c o pe . It will be ma de fr o m a s oft, bi oc o m pati ble, a n d tear-r esista nce silic o ne uret ha ne elas t o mer t hat is i deal f or s ki n-c o ntact a n d m uc osal me m bra ne a p plicati o ns. T his s oft silic o n e uret ha ne elast o mer is k n o w n as SI L -3 0 a n d will be s u p plie d t o us fr o m Car b o n, I nc. It has u n der g o ne ri g or o us bi oc o m p ati bilit y/sterilit y testi n g w hic h ma kes it i deal f or s h ort-ter m m uc osal me m bra ne c o nt act ( u p t o 2 4 h i n d urati o n). See A p pe n di x B f or a d diti o nal details relati n g t o bi oc o m pati bilit y a n d sterilit y.  
Asse m bl y: All c o m p o ne nts will be sec ure d t o get her usi n g me dical -gra d e, bi oc o m pati ble L octite  
\# 4 3 5 c ya n oacr ylate ( H e n kel C or p orati o n, R oc k y Hill, C T). T he L octite c ya n oacr yl ate will be all o we d t o c ure f or a f ull 2 4 h o urs bef or e pr ocee di n g t o sterilizati o n.  
Steriliz ati o n: F oll o wi n g asse m bl y, t he c o m plete d N u Vie w de vi ce will be sterilize d acc or di n g t o pr ot oc ols vali date d b y S T E RI S ( M e nt or, O hi o ) a n d i ncl u de d i n A p p e n di x B , S T E RI S Stea m Sterilizati o n Vali dati o n Re p ort, w hic h s pecifi es t he f oll o wi n g para m eters:  
| Sterilizer T y pe:                                                             | Pre vac u u m                               |         |
|--------------------------------------------------------------------------------|---------------------------------------------|---------|
| Mi ni m u m Te m perat ure:                                                    |                                             | 1 3 2 C |
| Sterilizati o n C ycle Ti me:  Dr y p hase:  Test Article C o nfi g urati o n: | 4 mi n utes  3 0 mi ns  Si n gle wra p pe d |         |  
A p pe n di x A: M A U D E d at a re vie w f or de vices si mil ar t o t he N u Vie w 4 8 T his secti o n pr o vi des a r e vie w of t he M A U D E data relate d t o t he Arc E n d oc uff de vi ce. T he d ata prese nte d is bas e d o n all a vaila ble r e p orts bet wee n Ja n uar y 1, 2 0 0 0 t o J ul y 3 1, 2 0 2 1. T o date, t here ha v e bee n a t otal of 1 1 M A U D E re p orts f or t he Arc E n d o c uff as s h o w n i n Ta ble 1 0 .  
| T a bl e 1 0 : M A U D E d at a f or t h e Ar c E n d o c uff   |                                       |                                              |                                                                           |                                       |
|-----------------------------------------------------------------|---------------------------------------|----------------------------------------------|---------------------------------------------------------------------------|---------------------------------------|
| M A U D E D A T A: A R C E N D                                  | O C U F F ( all a v ail a ble d at a) |                                              |                                                                           |                                       |
| De vice                                                         | D ate                                 | Pr o ble m                                   | Descri pti o n                                                            | H ar m                                |
| K 1 5 1 8 0 1                                                   | 1 2/ 0 9/ 2 0 1 5                     | Detac h me nt of d e vice c o m p o n e nt   | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt         |
| K 1 5 1 8 0 1                                                   | 1 0/ 2 4/ 2 0 1 5                     | Detac h me nt of d e vice c o m p o n e nt   | De v ice detac h es fr o m t he  e n d osc o pe                           | N o h ar m t o t he p atie nt         |
| K 1 5 1 8 0 1                                                   | 1 0/ 2 4/ 2 0 1 5                     | Detac h me nt of d e vice c o m p o n e nt   | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt         |
| K 1 5 1 8 0 1                                                   | 7/ 2 3/ 2 0 1 5                       | Brea k; d etac h me nt of de vice            | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt         |
| c o m p o ne nt                                                 |                                       |                                              |                                                                           |                                       |
| K 1 5 1 8 0 1                                                   | 5/ 1 3/ 2 0 1 5                       | Detac h me nt of d e vice c o m p o n e nt   | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt         |
| K 1 5 1 8 0 1                                                   | 4/ 2 9/ 2 0 1 5                       | Detac h me nt of d e vice                    | De vice detac h es fr o m t he  en d osc o pe                             | N o h ar m t o t he p atie nt         |
| c o m p o ne nt; Diffic ult t o re m o ve                       |                                       |                                              |                                                                           |                                       |
| K 1 5 1 8 0 1                                                   | 4/ 1 7/ 2 0 1 5                       | Detac h me nt of d e vice c o m p o n e nt   | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt         |
| K 1 5 1 8 0 1                                                   | 2/ 1 9/ 2 0 1 4                       | A d v erse E ve nt Wit h o ut I d e ntifie d | A n a d v erse e v e nt t h at was  n ot attri b ute d t o t h e d e vice | N o h ar m attri b ute d t o de v ice |
| De vice or Use Pr o ble m                                       |                                       |                                              |                                                                           |                                       |
| K 1 5 1 8 0 1                                                   | 1 0/ 1 8/ 2 0 1 3                     | A d v erse E ve nt Wit h o ut I d e ntifie d | A n a d v erse e v e nt t h at was  n ot attri b ute d t o t h e d e vice | N o h ar m attri b ute d t o de vice  |
| De vice or Use Pr o ble m                                       |                                       |                                              |                                                                           |                                       |  
Re vie w of t he a vaila ble M A U D E data f or t he pre dicate de vice, t he Arc E n d oc uff, s h o ws t hat t he m ost c o m m o nl y re p orte d de vice pr o ble m is t hat of detac h me nt fr o m t he e n d osc o pe. T h ese detac h me nts d o n ot a p pear t o res ult i n a n y har m t o t he patie nt, as i n all 8 u ni nte n de d detac h me nt e ve nts, n o patie nt was re p orte d t o ha ve bee n har me d a n d n o f oll o w u p treat me nt was rec o m me n de d i n a n y case. F urt h er, n o n e of t h ese d etac h me nt e ve nts has bee n c o ntri b ute d t o mis use of t he de vice i n a n y of t he M A U D E d ata base r e ports.  
T he o ut p ut of t his M A U D E data has bee n i nc or p orate d i nt o t he pr o d uct de vel o p me nt pr ocess of t he E n d o T heia N u Vie w. F urt her, a r e vie w of t he M A U D E data bas e i n dicates t hat s ur ge o ns ca n use t he Arc E n d oc uff pre dicate de vice saf el y, as n ot a si n gle har m of seri o us nat ure was attri b ute d t o t he de vice i n a n y of t he M A U D E re p orts. It t heref ore st a n ds t o r eas o n t hat, d ue t o t h e si milarities bet wee n t he Ar c E n d oc uff a n d t he E n d o T heia N u Vie w, s ur ge o ns s h o ul d als o be a ble t o use t he N u Vie w safel y. We will c o nfir m t his t hr o u g h o ur Use Relate d Ris k Assess me nt pr ocess, as well as t hr o u g h o ur de v el o p me nt Verificati o n & Vali dati o n testi n g.
untitled h1
m a u d e

As part of o ur ris k assess me nt, a n d i n a n eff ort t o ta ke a br oa d a p pr oac h at u n dersta n di n g t he p ote ntial use r elate d err ors t hat users mi g ht e x p erie nce w hile usi n g t he N u Vie w de vi ce, we ha ve als o re vie w e d t he M A U D E data bas e re p orts f or ot her si milar de vice s t o t h e E n d o T heia N u Vie w.  
E n d o Ai d's E n d o Ri n gs dist al e n d osc o pe att ac h me nt device: E n d o Ai d's E n d o Ri n gs is a distal e n d osc o pe attac h me nt a n d is ver y si milar t o t he N u Vie w i n b ot h tec h n ol o g y a n d i n i nte n de d use. T he E n d o Ri n gs de vice has t he f oll o wi n g i nte n de d use, "T he E n d o Ri n gs is i nte n de d t o be att ac he d t o t he dist al e n d of t he e n d osc o pe t o f acilit ate e n d osc o pic t her a py, t o be use d f or t he f oll o wi n g: Kee pi n g t he s uit a ble de pt h of e n d osc o pe's vie w fiel d. "  
Beca use of t he si milarities bet wee n t he t w o de vi ces, we belie ve t hat t he M A U D E data bas e re p orts f or t he E n d o Ri n gs ar e hi g hl y rele va nt t o t he N u Vie w de vice a n d s h o ul d be c o nsi dere d i n o ur d esi g n pr ocess. All a v aila ble re p orts f or t he E n d o Ri n gs ar e prese nt e d i n Ta ble 1 1 .  
| T a bl e 1 1 : M A U D E d at a f or E n d ori n gs   |                   |                                           |                                                                           |                               |
|-------------------------------------------------------|-------------------|-------------------------------------------|---------------------------------------------------------------------------|-------------------------------|
| M A U D E D A T A: E N D                              | O RI N            | G S ( all a v ail a ble d at a)           |                                                                           |                               |
| De vice                                               | Re p ort          | Pr o ble m                                | Descri pti o n                                                            | H ar m                        |
| K 1 3 3 3 5 9                                         | 1 2/ 0 1/ 2 0 1 7 | Detac h me nt Of De vice                  | De vi ce detac h es fr o m t he  e n d osc o pe                           | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 2/ 0 8/ 2 0 1 7 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 2/ 0 8/ 2 0 1 7 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 1/ 2 7/ 2 0 1 7 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 1 2/ 1 3/ 2 0 1 6 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 7/ 1 3/ 2 0 1 6 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 3/ 1 8/ 2 0 1 6 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 3/ 0 3/ 2 0 1 6 | Detac h me nt Of De vice                  | De vice detac h es fr o m t he  e n d osc o pe                            | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 8/ 2 7/ 2 0 1 5 | Detac h me nt Of De vice                  | De vi ce detac h es fr o m t he  e n d osc o pe                           | N o h ar m t o t he p atie nt |
| C o m p o ne nt                                       |                   |                                           |                                                                           |                               |
| A d verse E ve nt Wit h o ut                          |                   |                                           |                                                                           |                               |
| K 1 3 3 3 5 9                                         | 0 8/ 1 3/ 2 0 1 5 | I d e ntifie d De vice or Use  Pr o ble m | A n a d v erse e v e nt t h at was  n ot attri b ute d t o t h e d e vice | N o h ar m t o t he p atie nt |  
It is clear t hat t he m ost c o m m o n pr o ble m wit h t he E n d o Ri n gs is u ni nte n de d de vice detac h me nt as all 1 0 re p orts are i n re gar d t o t his o bser ve d pr o ble m. W hile t her e was n o patie nt har m i n a n y of t hese re p orts, it is i m p orta nt i nf or mati o n re gar di n g li kel y a d verse e ve nts t hat we c o ul d p ote ntiall y see i n re g ar ds t o t he N u Vie w de vice. We h a ve ta ke n t his i nf or mati o n i nt o acc o u nt wit hi n o ur desi g n a n d de vel o p me nt pr ocess a n d pla n t o i ncl u de ris k miti gati o ns relati n g t o detac h me nt s uc h as t he i ncl usi o n of clas pi n g f eat ur es as well as s pecific t olera n ce s pecs relati n g t he N u Vie w/e n d osc o p e fitti n g. E xact ris k c o ntr ols ar o u n d p ossi ble detac h me nt e ve nts ar e still u n der de vel o p me nt. A n ot her t hi n g t hat sta n ds o ut i n r e g ar ds t o t h e M A U D E d ata f or t he E n d o Ri n gs is t hat t he de vi ce a p pears t o be relati vel y s afe t o us e as n o ne of t hes e d etac h me nt e ve nts l e d t o a n y patie nt/ user har m.  
U nite d St ates E n d osc o py Gr o u p's T he U S E n d osc o py Dist al Att ac h me nt C a p device:  
A n ot her de vice w hic h is si milar t o t he N u Vie w de vice i n ter ms of tec h n ol o gical c har acteristics is t hat of U nite d States E n d osc o p y Gr o u p's "T h e U S E n d osc o py Dist al Att ac h me nt C a p " de vice. T his de vice's i nte n de d use is s o me w hat si milar t o t he N u Vie w de vice e x ce pt t hat it als o i ncl u des a n i n dicati o n f or " gastr oi ntesti nal m uc osal resecti o n" w hic h t he N u Vie w de vice is n ot i nte n de d f or. Still, M A U D E re p orts f or t he U S E n d osc o p y Distal Attac h me nt Ca p are rele v a nt t o t he N u Vie w i n t hat t he y ar e b ot h distal e n d osc o pe attac h me nt t y pe de vices. All p u blicl y a vaila ble M A U D E data f or T he U S E n d osc o p y Distal Attac h me nt Ca p is prese nte d i n Ta ble 1 2 .  
| T a bl e 1 2 : M A U D E d at a f or R e v e al Dist al Att a c h m e nt C a p   |                                    |                                           |                                               |                               |
|----------------------------------------------------------------------------------|------------------------------------|-------------------------------------------|-----------------------------------------------|-------------------------------|
| M A U D E D A T A:                                                               | R E V E A L DI S T A L A T T A C H | M E N T C A P ( all a v ail a ble d at a) |                                               |                               |
| De vice                                                                          | Re p ort                           | Pr o ble m                                | Descri pti o n                                | H ar m                        |
| K 1 4 0 3 1 5                                                                    | 0 1/ 2 9/ 2 0 2 1                  | Detac h me nt Of De vice  C o m p o ne nt | De vice detac h es fr o m t he e n d osc o pe | N o h ar m t o t he p atie nt |
| K 1 4 0 3 1 5                                                                    | 0 7/ 2 9/ 2 0 1 9                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 2/ 1 3/ 2 0 1 9                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 9/ 2 6/ 2 0 1 8                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 4/ 0 8/ 2 0 1 6                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 4/ 0 8/ 2 0 1 6                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 3/ 0 3/ 2 0 1 6                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |
| K 1 4 0 3 1 5                                                                    | 0 9/ 1 7/ 2 0 1 5                  | Detac h me nt Of De vice  C o m p o ne nt |                                               |                               |  
K 1 4 0 3 1 5 0 7/ 2 9/ 2 0 1 9 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 2/ 1 3/ 2 0 1 9 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 9/ 2 6/ 2 0 1 8 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 4/ 0 8/ 2 0 1 6 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 4/ 0 8/ 2 0 1 6 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 3/ 0 3/ 2 0 1 6 Detac h me nt Of De vice  
C o m p o ne nt  
K 1 4 0 3 1 5 0 9/ 1 7/ 2 0 1 5 Detac h me nt Of De vice  
C o m p o ne nt  
T he M A U D E data f or T h e U S Distal Attac h me nt C a p de vice p oi nts t o u ni nte n de d detac h me nt as  
t he m ost c o m m o n pr o ble m f or t his de vice. Si nce t his de vice's i ntr o d ucti o n i nt o t he mar ket place  
t here h a ve b ee n a t otal of 9 re p orts, all of w hic h rel ate t o t he u ni nte n d e d detac h me nt of t he de vice.  
N o patie nt/ user har m was see n i n a n y of t hese 9 re p orts, a gai n s u g gesti n g t hat t his de vice (li ke t he  
E n d o Ri n gs de vice) a p p ears t o be relati vel y safe f or use.  
O verall, o ur r e vie w of t h e M A U D E data b ase f or de vices si milar t o t he N u Vie w de vice s u g g est  
t hat u ni nte nti o nal de vice detac h me nt will be t he m ost pr o ba ble pr o ble m t hat we are li kel y  
e nc o u nter. F ort u natel y, t his pr o ble m d oes n ot a p p ear t o lea d t o a seri o us le vel har m, as n o n e of t he  
re p orts s u g gest patie nt har m relate d t o t his detac h me nt iss ue. Ne vert heless, we are t a ki n g t his i nt o  
u n der a d vise me nt d uri n g t he de vel o p me nt of o ur de vice a n d pla n t o i m ple me nt ris k c o ntr ols f or  
t his k n o w n iss ue i n ot her si milar de vices.  
A p pe n di x B: De vice Bi oc o m p ati bilit y &  
Sterilit y I nf or m ati o n 5 2  
SI L 3 0  
  
SI L 3 0 is a s oft, bi o c o m p ati bl e, a n d t e ar -r esist a nt sili c o n e ur et h a n e el ast o m er t h at is i d e al f or s ki n -  
c o nt a ct a p pli c ati o ns.  
© 2 01 9 - 2 0 2 0 C ar b o n, I nc. All ri g hts r es er ve d. C ar b o n, I nc. C o nfi d e nti al/ Pr o pri et ar y  
| T e n sil e Pr o p erti es  A S T M D 412, Die C, 5 0 0 m m/ mi n                 | M etri c                                 | U S         |
|-----------------------------------------------------------------------------------|------------------------------------------|-------------|
| T e nsile M o d ul us                                                             | 3 M Pa                                   | 4 4 0 psi   |
| El o n gati o n at Break                                                          | 3 5 0 %                                  | 3 5 0 %     |
| Stress at 5 0 % El o n gati o n                                                   | 0. 4 M Pa                                | 6 0 psi     |
| Stress at 1 0 0 % El o n gati o n                                                 | 0.7 M Pa                                 | 1 0 0 psi   |
| Stress at 2 0 0 % El o n gati o n                                                 | 1. 5 M Pa                                | 22 0 psi    |
| Ulti mat e T e nsile Stre n gt h                                                  | 3. 5 M Pa                                | 5 0 0 psi   |
| Ot h er M e c h a ni c al Pr o p erti es                                          | M etri c                                 | U S         |
| T ear Stre n gt h, Die C ( die c ut), A S T M D 62 4                              | 1 0 k N/ m                               | 57 l bf/i n |
| C o m pressi o n S et, 23 °C, 72 h, A S T M D 3 9 5 - B                           | 1 0 %                                    | 1 0 %       |
| Bays h ore R e b o u n d R esilie nce, A S T M D 2 6 32                           | 2 0 %                                    | 2 0 %       |
| T h er m al Pr o p erti es                                                        | M etri c                                 | U S         |
| ( D M A, ta n( d)), A S T M D 4 0 6 5                                             | 1 0 ° C                                  | 5 0 ° F     |
| Di el e ctri c/ El e ctri c Pr o p erti es Dielectric C o nsta nt, A S T M D1 5 0 | 7. 6                                     |             |
| Dissi pati o n Fact or, A S T M D1 5 0                                            | 0.1 5                                    |             |
| G e n er al Pr o p erti es Har d n ess, A S T M D 22 4 0                          | 3 5 (I nsta nt), 31 ( 5 s ec), S h ore A |             |
| D e nsity, A S T M D7 92                                                          | 1. 07 g/c m                              |             |
| D e nsity (li q ui d)                                                             | 1. 0 5 g/c m                             |             |  
T he i nf or mati o n i n t his d oc u me nt i ncl u d es val u es d eriv e d fr o m pri nti n g vari o us parts, reflects a n a p pr oxi mati o n of t he mea n val u e of a ra n ge of val u es, a n d is i nte n d e d f or refere nce a n d c o m paris o n p ur p oses o nly . T his i nf or mati o n s h o ul d n ot b e use d f or testi n g, d esi g n s p ecificati o n or q uality c o ntr ol p ur p oses . E n d -use material p erf or ma nce ca n b e i m pacte d by, b ut n ot li mite d t o, d esi g n, pr ocessi n g, c ol or treat me nt, o p erati n g a n d e n d -use c o n diti o ns, test c o n diti o ns, etc . Act ual val u es will vary wit h b uil d c o n diti o ns. I n a d diti o n, pr o d uct s p ecificati o ns are s u bject t o c ha n ge wit h o ut n otice .  
T his i nf or mati o n a n d Car b o n's tec h nical a dvice are giv e n t o y o u i n g o o d fait h b ut wit h o ut warra nty . T he a p plicati o n, use a n d pr ocessi n g of t hese a n d ot her Car b o n pr o d ucts by y o u are b ey o n d Car b o n's c o ntr ol a n d, t heref ore, e ntirely y o ur o w n res p o nsi bility. Car b o n pr o d ucts are o nly t o b e use d by y o u, s u bject t o t he ter ms of t he writte n a gre e me nt by a n d b et w e e n y o u a n d Car b o n .  
Y o u are res p o nsi ble f or d eter mi ni n g t hat t he Car b o n material is safe, la wf ul, a n d tec h nically s uita ble f or t he i nte n d e d a p plicati o n, as w ell as f or i d e ntifyi n g t he pr o p er dis p osal ( or recycli n g) met h o d c o nsiste nt wit h a p plica ble e nvir o n me ntal la ws a n d re g ulati o ns. C A R B O N M A K E S N O  
W A R R A N TI E S O F A N Y KI N D,  
E X P R E S S E D O R I M P LI E D,  
I N C L U DI N G, B U T N O T LI MI T E D T O,  
T H E W A R R A N TI E S O F  
M E R C H A N T A BI LI T Y, FI T N E S S F O R A  
P A R TI C U L A R U S E, O R N O N -  
I N F RI N G E M E N T. F urt her, it is ex pressly u n d erst o o d a n d a gre e d t hat y o u ass u me a n d here by ex pressly release Car b o n fr o m all lia bility, i n t ort, c o ntract or ot her wise, i nc urre d i n c o n necti o n wit h t he use of Car b o n pr o d ucts, tec h nical assista nce a n d i nf or mati o n. N o lice nsewit h res p ect t o a ny i ntellect ualpr o p erty is i m plie d.  
Parts w ere pr ocesse d usi n g a n M  
series pri nter a n d a S mart Part Was her wit h V F 1 as t he s olv e nt.  
SI L 3 0  
  
  
E xt e n d e d T D S
si l 3 0 m
m a u d e

R e pr es e nt ati v e T e nsil e C ur v e A S T M D 412, Die C, 5 0 0 m m/ mi n
sil 30 dynamic mechanical analysis
m a u d e

Dynamic mechanical analysis provides insight into a material's viscoelastic properties across a range of temperatures. The figure below shows a temperature ramp of SIL 30. The peak in the tan(d) curve indicates that the glass transition temperature for this material is approximately 10 °C. A rubbery plateau is observed in the storage modulus from 20 - 150 °C  reflecting the elastic nature of this material within this temperature window.  
  
Print Conditions: All DMA samples were printed using software v1.9. Samples were hand-wiped and not washed with solvent. The thermal cure for all materials complies with the Carbon user manual.  
Carbon, Inc. Confidential/Proprietary
si l 3 0 c
m a u d e

| M ass G ai n* ( %)                                                        |             |
|---------------------------------------------------------------------------|-------------|
| H o us e h ol d C h e mi c als Bl e a c h ( N a Cl O , 5 %)               | < 5 %       |
| S a nitiz er ( N H Cl, 1 0 %)                                             | 5 - 1 5 %   |
| Distill e d W at er                                                       | 5 - 1 5 %   |
| S u ns cr e e n ( B a n a n a B o at, S P F 5 0)                          | 5 - 1 5 %   |
| D et er g e nt ( Ti d e, Ori gi n al)                                     | 5 - 1 5 %   |
| Wi n d e x P o w eriz e d F or m ul a                                     | 5 - 1 5 %   |
| H y dr o g e n P er o xi d e ( 3 0 %)                                     | 1 5 - 3 0 % |
| Et h a n ol ( 9 5 %)                                                      | > 3 0 %     |
| I n d ustri al Fl ui ds E n gi n e Oil ( H a v oli n e S A E 5 W -3 0)    | < 5 %       |
| Br a k e Fl ui d ( C astr ol D O T -4)                                    | > 3 0 %     |
| Air pl a n e D ei ci n g Fl ui d ( T y p e I Et h yl e n e Gl y c ol)     | < 5 %       |
| Air pl a n e D ei ci n g Fl ui d ( T y p e I Pr o p yl e n e Gl y c ol)   | 5 - 1 5 %   |
| Air pl a n e D ei ci n g Fl ui d ( T y p e I V Et h yl e n e Gl y c ol)   | < 5 %       |
| Air pl a n e D ei ci n g Fl ui d ( T y p e I V Pr o p yl e n e Gl y c ol) | 5 - 1 5 %   |
| Tr a ns missi o n Fl ui d ( H a v oli n e S y nt h eti c A T F)           | < 5 %       |
| E n gi n e C o ol a nt ( H a v oli n e X L C, 5 0 %/ 5 0 % pr e mi x e d) | < 5 %       |
| Di es el ( C h e vr o n # 2)                                              | 1 5 - 3 0 % |
| G as oli n e ( C h e vr o n # 91)                                         | > 3 0 %     |
| S k y dr ol 5 0 0 B - 4                                                   | > 3 0 %     |
| Str o n g A ci d/ B as e S ulf uri c A ci d ( 3 0 %)                      | > 3 0 %     |
| S o di u m H y dr o xi d e (1 0 %)                                        | < 5 %       |  
* P er c e nt w ei g ht g ai n e d aft er 1 w e e k s u b m ersi o n f oll o wi n g A S T M D 5 4 3. V al u e s d o n ot r e pr e s e nt c h a n g e s i n di m e nsi o n or m e c h a ni c a l pr o p erti e s.
si l 3 0 c
si l 3 0 u

N at ural p oly m er a gi n g ca n occ ur i n t h e pr es e nc e of li g ht, s u n, a n d h eat. C ar b o n e val u at e d t h e U V a gi n g p erf or ma nc e of SI L  
3 0 usi n g A S T M D 4 4 5 9, w hic h is i nt e n d e d t o si m ulat e i n d o or ex p os ur e of s olar ra diati o n t hr o u g h glass.  
  
A S T M D 4 4 5 9: Q- S u n X E -1, 0. 8 W/ m at 4 2 0 n m, 5 5 °C  
A S T M D 41 2: Di e C, 5 0 0 m m/ mi n, av era g e v al u es r e pr es e nt e d SI L 3 0 U V A gi n g  
N at ural p oly m er a gi n g ca n occ ur i n t h e pr es e nc e of li g ht, s u n, a n d h eat. C ar b o n e val u at e d t h e U V a gi n g p erf or ma nc e of SI L  
3 0 usi n g A S T M D 4 4 5 9, w hic h is i nt e n d e d t o si m ulat e i n d o or ex p os ur e of s olar ra diati o n t hr o u g h glass.  
  
A S T M D 4 4 5 9: Q- S u n X E -1, 0. 8 W/ m at 4 2 0 n m, 5 5 °C  
A S T M D 41 2: Di e C, 5 0 0 m m/ mi n, av era g e v al u es r e pr es e nt e d
si l 3 0 c
si l 3 0 bi

Bi oc o m pati bility T esti n g Pri nt e d parts w er e pr o vi d e d t o N A M S A f or e val uati o n i n acc or da nc e wit h I S O 1 0 9 9 3- 5 , Bi ol o gic al e val u ati o n of m e dic al d e vic es - P art 5:  
T ests f or i n vitr o c yt ot oxicit y , a n d I S O 1 0 9 9 3-1 0, Bi ol o gic al e val u ati o n of m e dic al d e vic es - P art 1 0: T ests f or irritati o n a n d s ki n s e nsitizati o n ( G P M T). Parts w er e pr oc ess e d usi n g a n M s eri es pri nt er a n d a S mart Part Was h er wit h V F 1 as t h e s ol v e nt. T h e r es ults f or all t ests i n dic at e d t hat SI L 3 0 pass e d t h e r e q uir e m e nts f or bi oc o m pati bility acc or di n g t o t h e a b o v e t ests. C ar b o n m a k es n o r e pr es e nt ati o n a n d is n ot r es p o nsi bl e f or t h e r es ults of a n y bi o c o m p ati bilit y t ests ot h er t h a n t h os e s p e cifi e d a b o v e.  
Discl ai m er Bi oc o m pati bility r es ults ma y var y bas e d o n pri nti n g a n d/ or p ost- pr oc essi n g pr oc e d ur es.  
S u bscri b er ac k n o wl e d g es t h e c o nt e nts of t his d oc u m e nt ar e s u bj e ct t o t h e T er ms a n d C o n diti o ns o utli n e d i n t h e S u bscri pti o n A g r e em e nt, i ncl u di n g t h e R estricti o ns o n Us e s e cti o n.  
D O N O T U S E C A R B O N M A T E RI A L S I N M E DI C A L A P P LI C A TI O N S I N V O L VI N G I M P L A N T A TI O N I N T H E H U M A N B O D Y O R C O N T A C T  
WI T H B O D Y F L UI D S O R TI S S U E S U N L E S S T H E M A T E RI A L H A S B E E N P R O VI D E D F R O M C A R B O N U N D E R A W RI T T E N C O N T R A C T  
T H A T I S C O N SI S T E N T WI T H T H E C A R B O N P O LI C Y R E G A R DI N G M E DI C A L A P P LI C A TI O N S A N D E X P R E S S L Y A C K N O W L E D G E S T H E  
C O N T E M P L A T E D U S E. C A R B O N M A K E S N O R E P R E S E N T A TI O N, P R O MI S E, E X P R E S S W A R R A N T Y O R I M P LI E D W A R R A N T Y  
C O N C E R NI N G T H E S UI T A BI LI T Y O F T H E S E M A T E RI A L S F O R U S E I N I M P L A N T A TI O N I N T H E H U M A N B O D Y O R I N C O N T A C T WI T H  
B O D Y F L UI D S O R TI S S U E S. If C ar b o n has p er mitt e d i n t h e S u bscri pti o n A gr e e m e nt us e of t h e C ar b o n pri nt er f or a p plic ati o ns t hat r eq uir e bi oc o m pati bility, S u bscri b er ac k n o wl e d g es t hat it is t h e r es p o nsi bility of S u bscri b er, its r es p e cti v e c ust o m ers a n d e n d- us ers t o d et er mi n e t h e bi oc o m pati bility of all pri nt e d parts f or t h eir r es p e cti v e us es.  
C ar b o n, I nc. | w w w.c ar b o n 3 d.c o m 1 0 8 9 Mills Wa y R e d w o o d City, C A 9 4 0 6 3 1 ( 6 5 0) 2 8 5- 6 3 07
bi o c o m
s i l 3 0

T h e pr ot o c ol s d e s cri b e d i n t hi s d o c u m e nt w er e t e st e d b y C ar b o n f or pri nti n g p art s fr o m SI L 3 0 R e si n m at eri al s o t h at t h e y ar e s uit a bl e f or pr ol o n g e d s ki n c o nt a ct ( m or e t h a n 3 0 d a y s ) a n d s h ort -t er m m u c o s al -  
m e m br a n e c o nt a ct ( u p t o 2 4 h o ur s ).  
F oll o w t h e i n str u cti o n s i n t hi s d o c u m e nt w h e n u si n g SI L 3 0 r e si n o n C ar b o n M 1 a n d M 2 pri nt er s t o e n s ur e bi o c o m p ati bilit y of t h e r e s ulti n g p art.  
R e si n Di s p e n si n g SI L 3 0 r e si n i s a t w o- c o m p o n e nt m at eri al s u p pli e d i n a d u al - c h a m b er, li g ht -r e si st a nt c artri d g e. At pri nt ti m e, t h e A a n d B c o m p o n e nt s ar e mi x e d i n a 1 : 1 r ati o u si n g a st ati c mi x er ti p att a c h e d t o t h e e n d of t h e c artri d g e w hi c h i n st all e d i nt o a Al bi o n m ot ori z e d di s p e n si n g u nit. It i s s u g g e st e d t h at t h e i niti al v ol u m e  
( ~ 5 m L) of r e si n i s b ur n e d i nt o a w a st e c o nt ai n er t o pr e v e nt off - st oi c hi o m etr y. A n a p pr o pri at e v ol u m e of t h e mi x e d r e si n ( a s s p e cifi e d b y t h e pri nt pl a n n er s oft w ar e ) i s t h e n di s p e n s e d i nt o t h e pri nt er c a s s ett e a n d t h e c a s s ett e i s pl a c e d o n t h e o pti c al d e c k.  
N o t e : W h e n s wit c hi n g b et w e e n m at eri al s, t h e c a s s ett e s h o ul d b e cl e a n e d wit h i s o pr o p a n ol (I P A) t o e n s ur e t h at r e si d u al r e si n fr o m t h e pr e vi o u s pri nt i s n ot mi x e d wit h t h e SI L 3 0 r e si n . F or a d diti o n al i nf or m ati o n s e e t h e " Cl e a ni n g t h e c a s s ett e " s e cti o n of t h e U s er G ui d e.
bi o c o m
pri nti n g

A cl e a n e d b uil d pl atf or m i s i n st all e d o nt o t h e Z - st a g e a n d t h e pri nt pr o c e s s i niti at e d b y u pl o a di n g a s uit a bl e S T L, e nt eri n g r u n p ar a m et er s (r e si n t y p e, pri nt ori e nt ati o n, s u p p ort c o n str u cti o n, et c.) a n d r e q u e sti n g pri nt i niti ati o n. Pri nt s p e e d a n d li g ht i nt e n sit y ar e c o ntr oll e d b y C ar b o n' s pr o pri et ar y s oft w ar e t o e n s ur e p art a c c ur a c y a n d d e gr e e of U V n et w or k c ur e.  
P art R e m o v al fr o m B uil d Pl atf or m O n c e t h e " gr e e n " st at e p art ( o nl y t h e U V n et w or k i s c ur e d ) i s b uilt, t h e b uil d pl atf or m i s r e m o v e d fr o m t h e pri nt er, t h e p art g e ntl y r e m o v e d fr o m t h e b uil d pl atf or m u si n g a v ari et y of s cr a p er s, t w e e z er s a n d bl a d e s .  
W a s hi n g R e m o v e e x c e s s r e si n u si n g s p o n g e s w a b s a n d wi p e s a n d wit h c o m pr e s s e d air (i n a c a bi n et ) .  
W a s h t h e p art s wit h mil d a git ati o n i n V e r t r el X M ™ , a n a z e otr o pi c mi xt ur e of 1, 1, 1, 2, 2, 3, 4, 5, 5, 5 -  
D e c afl u or o p e nt a n e a n d m et h a n ol ( 9 1 - 9 3 t o 9 -7, w/ w, C h e m o ur s ™ ) f or 3 t o 5 mi n ut e s. A git ati o n c a n b e a c hi e v e d b y pl a ci n g t h e p art s i n a st ai nl e s s st e el s m all - p art s b a s k et a n d r ot ati n g t h e b a s k et at 5 - 2 0 r p m i n s uffi ci e nt V ertr el X M ™ t o c o v er or u si n g t h e C ar b o n S m art P art W a s h er. I n t h e l att er c a s e, t h e w a s h er will pr o vi d e t h e pr o p er w a s h c y cl e.  
F or a d diti o n al i nf or m ati o n , s e e t h e " W a s hi n g p art s " s e cti o n of t h e U s er ' s G ui d e.  
S u p p ort R e m o v al  
  
S u p p ort s c a n b e r e m o v e d pri or t o w a s hi n g or aft er t h e w a s h a n d c ur e c y cl e s. T o r e m o v e s u p p ort m at eri al fr o m t h e pri nt e d p art, u s e cl e a n t w e e z er s or cl e a n pr ot e cti v e gl o v e s.  
F or a d diti o n al i nf or m ati o n , s e e t h e " R e m o vi n g s u p p ort s " s e cti o n of t h e U s er ' s G ui d e.  
T h er m al C ur e Pl a c e t h e p art s o n a n o n - sti c k tr a y. T h e n pl a c e t h e tr a y i n a cl e a n, d e di c at e d c o n v e cti o n o v e n at 1 2 0 ° C f or 8 h o ur s.  
Bi o c o m p ati bilit y T e sti n g P art s pri nt e d a n d pr o c e s s e d a s o utli n e d i n t hi s d o c u m e nt w er e pr o vi d e d t o N A M S A f or e v al u ati o n i n a c c or d a n c e wit h I S O 1 0 9 9 3 -5, Bi ol o gi c al e v al u ati o n of m e di c al d e vi c e s - P art 5: T e st s f or i n vitr o c yt ot o xi cit y , a n d I S O 1 0 9 9 3 -1 0, Bi ol o gi c al e v al u ati o n of m e di c al d e vi c e s - P art 1 0: T e st s f or irrit ati o n a n d s ki n s e n siti z ati o n ( G P M T ) . T h e r e s ult s f or all t e st s i n di c at e d t h at SI L 3 0 re si n p a s s e d t h e r e q uir e m e nt s f or bi o c o m p ati bilit y a c c or di n g t o t h e a b o v e t e st s. C ar b o n m a k e s n o r e pr e s e nt ati o n a n d i s n ot r e s p o n si bl e f or t h e r e s ult s of a n y bi o c o m p atibilit y t e st s ot h er t h a n t h o s e s p e cifi e d a b o v e .
bi o c o m
di s cl ai m

Bi o c o m p ati bilit y r e s ult s m a y v ar y if pr ot o c ol s ar e u s e d ot h er t h a n t h o s e o utli n e d i n t hi s d o c u m e nt.  
S u b s cri b er a c k n o wl e d g e s t h e c o nt e nt s of t hi s d o c u m e nt ar e s u bj e ct t o t h e T er m s a n d C o n diti o n s o utli n e d i n t h e S u b s cri pti o n A gr e e m e nt, i n cl u di n g t h e R e stri cti o n s o n U s e s e cti o n.  
D O N O T U S E C A R B O N M A T E RI A L S I N M E DI C A L A P P LI C A TI O N S I N V O L VI N G I M P L A N T A TI O N I N T H E H U M A N  
B O D Y O R C O N T A C T WI T H B O D Y F L UI D S O R TI S S U E S U N L E S S T H E M A T E RI A L H A S B E E N P R O VI D E D F R O M  
C A R B O N U N D E R A W RI T T E N C O N T R A C T T H A T I S C O N SI S T E N T WI T H T H E C A R B O N P O LI C Y R E G A R DI N G  
M E DI C A L A P P LI C A TI O N S A N D E X P R E S S L Y A C K N O W L E D G E S T H E C O N T E M P L A T E D U S E. C A R B O N M A K E S  
N O R E P R E S E N T A TI O N, P R O MI S E, E X P R E S S W A R R A N T Y O R I M P LI E D W A R R A N T Y C O N C E R NI N G T H E  
S UI T A BI LI T Y O F T H E S E M A T E RI A L S F O R U S E I N I M P L A N T A TI O N I N T H E H U M A N B O D Y O R I N C O N T A C T  
WI T H B O D Y F L UI D S O R TI S S U E S.  
If C ar b o n h a s p er mitt e d i n t h e S u b s cri pti o n A gr e e m e nt u s e of t h e C ar b o n pri nt er f or a p pli c ati o n s t h at r e q uir e bi o c o m p ati bilit y, S u b s cri b er a c k n o wl e d g e s t h at it i s t h e r e s p o n si bilit y of S u b s cri b er, it s r e s p e cti v e c u st o m er s a n d e n d - u s er s t o d et er mi n e t h e bi o c o m p ati bilit y of all pri nt e d p art s f or t h eir r e s p e cti v e u s e s.  
C a r b o n, I n c. | w w w. c ar b o n 3 d. c o m 1 0 8 9 Mill s W a y R e d w o o d Cit y, C A 9 4 0 6 3 1 ( 6 5 0) 2 8 5- 6 3 0 7
bi o c o m
t o u g h

T h e p ur p o s e of t hi s p a p er i s t o e v al u at e t h e c o m p ati bilit y of F or ml a b s T o u g h 1 5 0 0 R e si n wit h v ari o u s  
bi ol o gi c al st erili z ati o n m et h o d s: a ut o cl a v e, g a m m a, e- b e a m, a n d et h yl e n e oxi d e st erili z ati o n ( Et O).  
C h a n g e s i n m e c h a ni c al pr o p erti e s will b e pr e s e nt e d pr e- a n d p o st- st erili z ati o n. T h e r e s ult s pr e s e nt e d ar e  
i nt e n d e d t o h el p i nf or m p ot e nti al u s e s, b ut s h o ul d n ot b e u s e d a s a s u b stit ut e f or a p pli c ati o n- s p e ci fi c  
t e sti n g.
bi o c o m
s a m pl e

All s a m pl e s w er e pri nt e d o n F or m 3 B S L A pri nt er s e q ui p p e d wit h cl e a n B uil d Pl atf or m s, F or m 3 R e si n Ta n k s  
a n d T o u g h 1 5 0 0 R e si n V 4 c artri d g e s. P art ori e nt ati o n s a n d pl a c e m e nt w er e k e pt c o n st a nt f or all s a m pl e s.  
P o st Pr o c e s si n g  
Aft er pri nti n g, t e sti n g s a m pl e s att a c h e d t o a b uil d pl atf or m w er e w a s h e d t wi c e i n a F or m W a s h. T h e fir st  
w a s h w a s 1 0 mi n ut e s i n < = 9 5 % I P A t o r e m o v e t h e m aj orit y of u n c ur e d r e si n. T h e s e c o n d w a s h w a s 1 0  
mi n ut e s i n > 9 9 % I P A t o e n s ur e r e m o v al of a n y r e si d u al u n c ur e d r e si n. C o m pr e s s e d air w a s u s e d t o dr y t h e  
p art s t h or o u g hl y. P art s w er e r e m o v e d fr o m s u p p ort s a n d c ur e d f or 6 0 mi n at 7 0 o C i n a F or m C ur e.  
F or ml a b s F or m W a s h, F or m C ur e, a n d fi ni s hi n g t o ol s w er e u s e d a c c or di n g t o t h e r e c o m m e n d e d I n str u cti o n  
f or U s e t o e n s ur e o pti m al p erf or m a n c e a n d bi o c o m p ati bilit y c o m pli a n c e.
bi o c o m
r e s ult s

Bi o c o m p ati bilit y Te sti n g  
Pri nt e d a n d p o st- pr o c e s s e d p art s w er e pr o vi d e d t o N A M S A f or I S O 1 0 9 9 3- 5, Bi ol o gi c al e v al u ati o n of  
m e di c al d e vi c e s - P art 5: Te st s f or i n vitr o c yt ot oxi cit y st u d y u si n g t h e I S O el uti o n m et h o d. T h e r e s ult s s h o w  
n o e vi d e n c e of c a u si n g c ell l y si s or c yt ot oxi cit y; wit h 0 % l y si s d et e ct e d.  
R e s ult s a n d c o n cl u si o n s of t h e c yt ot oxi cit y t e sti n g ar e b a s e d o n a st a n d ar d g e o m etr y a n d s a m pl e s et p er  
I S O 1 0 9 9 3- 5. Bi o c o m p ati bilit y a n d st erili z ati o n c o m p ati bilit y r e s ult s m a y v ar y if t h er e ar e a n y d e vi ati o n s  
fr o m t h e r e c o m m e n d e d I n str u cti o n s f or u s e. F or ml a b s i s n ot r e s p o n si bl e f or a n y bi o c o m p ati bilit y r e s ult s  
e x c e pt t h e o n e s p e ci fi e d i n t hi s r e p ort. U s er s ar e r e s p o n si bl e f or c o n fir mi n g bi o c o m p ati bilit y f or t h eir  
s p e ci fi c a p pli c ati o n.  
M e c h a ni c al Pr o p ert y Te sti n g  
T e n sil e T e sti n g: Te n sil e b ar s ( A S T M D 6 3 8 Ty p e I) w er e pr e p ar e d a s d e s cri b e d i n t h e " S a m pl e  
Pr e s e nt ati o n" s e cti o n. T h e s a m pl e s w er e c o n diti o n e d a n d t e st e d a c c or di n g t o A S T M D 6 3 8.
Fl e x ur al T e sti n g: Fl e x ur al b ar s w er e pr e p ar e d a s d e s cri b e d i n t h e " S a m pl e Pr e p ar ati o n" s e cti o n. T h e  
s a m pl e s w er e c o n diti o n e d a n d t e st e d a c c or di n g t o A S T M D 7 9 0 - M et h o d B.  
P art s pri nt e d a n d t e st e d u n d er di ff er e nt c o n diti o n s, s u c h a s pri nt er, st or a g e c o n diti o n s, et c. m a y pr o d u c e  
di ff er e nt r e s ult s.
bi o c o m
a ut o cl a

Te n sil e a n d fl e x ur al b ar s a m pl e s w er e pr o vi d e d t o S T E RI S f or a ut o cl a v e pr o c e s si n g. T h e p art s u n d er w e nt  
5 c y cl e s of pr e- v a c u u m st e a m st erili z ati o n at 1 3 2 o C wit h a 4- mi n ut e st erili z ati o n p h a s e a n d 3 0 mi n ut e s dr y  
p h a s e. P art s w er e all o w e d t o c o ol 3 0 mi n ut e s b et w e e n c y cl e s.  
T h e m e c h a ni c al pr o p ert y t e sti n g b el o w s h o w s t h e c o m p ati bilit y of T o u g h 1 5 0 0 R e si n pri nt e d p art s wit h  
a ut o cl a v e st erili z ati o n. N o a p pr e ci a bl e l o s s e s i n m at eri al pr o p erti e s, d ef or m ati o n s, cr a c ki n g or si g ni fi c a nt  
c h a n g e s i n c ol or w er e o b s er v e d aft er pr o c e s si n g. Fl e x ur al pr o p erti e s w er e t e st e d a n d f oll o w e d si mil ar  
tr e n d s a s t e n sil e t e sti n g.  
C h a n g e i n Ulti m at e Te n sil e Str e n gt h ( M P a) C h a n g e i n Ulti m at e Te n sil e M o d ul u s ( M P a)
bi o c o m
g a m m a

Te n sil e a n d fl e x ur al b ar s a m pl e s w er e pr e p ar e d a n d pr o vi d e d t o St eri g e ni c s - R o c k a w a y, N J f or G a m m a  
pr o c e s si n g. T h e s a m pl e s w er e e x p o s e d t o 2 9. 4- 31. 2 k G y of g a m m a r a di ati o n.  
P art s w er e pr o vi d e d b a c k t o F or ml a b s f or m e c h a ni c al pr o p ert y t e sti n g u si n g A S T M D 6 3 8 a n d A S T M D 7 9 0  
c o m pli a nt m et h o d s. T h e m e c h a ni c al pr o p ert y t e sti n g b el o w s h o w s t h e c o m p ati bilit y of T o u g h 1 5 0 0 R e si n  
pri nt e d p art s wit h g a m m a st erili z ati o n. N o a p pr e ci a bl e l o s s e s i n m at eri al pr o p erti e s, d ef or m ati o n s,  
cr a c ki n g or si g ni fi c a nt c h a n g e s i n c ol or w er e o b s er v e d aft er pr o c e s si n g. Fl e x ur al pr o p erti e s w er e t e st e d  
a n d f oll o w e d si mil ar tr e n d s a s t e n sil e t e sti n g.  
C h a n g e i n Ulti m at e Te n sil e Str e n gt h ( M P a) C h a n g e i n Ulti m at e Te n sil e M o d ul u s ( M P a)  
  
C h a n g e i n Str ai n at Br e a k
bi o c o m
e- b e a m

Te n sil e a n d fl e x ur al b ar s a m pl e s w er e pr e p ar e d a n d pr o vi d e d t o St eri g e ni c s - S a n Di e g o, C A, f or e- b e a m  
pr o c e s si n g. T h e s a m pl e s w er e e x p o s e d t o a s urf a c e d o s e of 3 5 k G y of e- b e a m r a di ati o n.  
P art s w er e pr o vi d e d b a c k t o F or ml a b s f or m e c h a ni c al pr o p ert y t e sti n g u si n g A S T M D 6 3 8 a n d A S T M D 7 9 0  
c o m pli a nt m et h o d s. T h e m e c h a ni c al pr o p ert y t e sti n g b el o w s h o w s t h e c o m p ati bilit y of T o u g h 1 5 0 0 R e si n  
pri nt e d p art s wit h e- b e a m st erili z ati o n. N o a p pr e ci a bl e l o s s e s i n m at eri al pr o p erti e s, d ef or m ati o n s,  
cr a c ki n g or si g ni fi c a nt c h a n g e s i n c ol or w er e o b s er v e d aft er pr o c e s si n g. Fl e x ur al pr o p erti e s w er e t e st e d  
a n d f oll o w e d si mil ar tr e n d s a s t e n sil e t e sti n g.
C h a n g e i n Ulti m at e Te n sil e Str e n gt h ( M P a) C h a n g e i n Ulti m at e Te n sil e M o d ul u s ( M P a)
bi o c o m
et h yl e n

Te n sil e a n d fl e x ur al b ar s a m pl e s w er e pr e p ar e d a n d pr o vi d e d t o Bl u e Li n e St erili z ati o n S er vi c e s f or Et O  
pr o c e s si n g. T h e s a m pl e s w er e c o n diti o n e d at 5 5° C, 5 0 % r el ati v e h u mi dit y, a n d 5 0 m b ar f or 7 8 mi n ut e s.  
T h e s a m pl e s w er e t h e n e x p o s e d t o a si n gl e c y cl e of 1 0 0 % Et O at 5 5° C f or 1 8 0 mi n ut e s.  
P art s w er e pr o vi d e d b a c k t o F or ml a b s f or m e c h a ni c al pr o p ert y t e sti n g u si n g A S T M D 6 3 8 a n d A S T M D 7 9 0  
c o m pli a nt m et h o d s. T h e m e c h a ni c al pr o p ert y t e sti n g b el o w s h o w s t h e c o m p ati bilit y of T o u g h 1 5 0 0 R e si n  
pri nt e d p art s wit h Et O st erili z ati o n. N o a p pr e ci a bl e l o s s e s i n m at eri al pr o p erti e s, d ef or m ati o n s, cr a c ki n g or  
si g ni fi c a nt c h a n g e s i n c ol or w er e o b s er v e d aft er pr o c e s si n g. Fl e x ur al pr o p erti e s w er e t e st e d a n d f oll o w e d  
si mil ar tr e n d s a s t e n sil e t e sti n g.  
  
  
Change in Strain at Break
bi o c o m
cl e a ni n

Gl Ass  
W PI s ells a n e w li n e of q u alit y b or osilic at e gl ass w ar e f or l a b or at ori es. T his articl e i ncl u d es i nf or m ati o n o n c ari n g f or y o ur gl ass w ar e.  
S o d a li m e gl ass is a s oft er gl ass a n d s h o ul d n ot b e us e d f or l a b or at or y p ur p os es, b ec a us e it c a n n ot e n d ur e t h e t e m p er at ur e or pr ess ur e c h a n g es of b or osilic at e gl ass, a n d it s h o ul d n ot b e a ut ocl a v e d at t h e hi g h t e m p er at ur es. M ost b ottl es ar e m a d e of s o d a li m e gl ass. T his articl e d e als wit h b or osilic at e gl ass. D o n ot mix s o d a li m e gl ass wit h b or osilic at e gl ass i n r ac ks w h e n y o u ar e cl e a ni n g or a ut ocl a vi n g.
bi o c o m
n e w gl ass

N e w gl ass w ar e is us u all y a littl e al k ali n e. Aft er i ns p ecti n g it f or cli ps a n d cr ac ks, w as h t h e gl ass i n w ar m, s o a p y w at er a n d t h e n s o a k it i n a s ol uti o n of 1 % H Cl or H N O f or a s h ort p eri o d of ti m e. W as h t h e gl ass w ar e a g ai n a n d ri ns e it t h or o u g hl y wit h distill e d w at er.
bi o c o m
w h y gl ass

W h e n l a b or at or y gl ass br e a ks u n d er n or m al us e, it is us u all y t h e r es ult of a c hi p, a br asi o n or scr atc h, or b ec a us e it w as ex p os e d t o q uic k t e m p er at ur e or pr ess ur e c h a n g es.  
I ns p ect y o ur l a b or at or y gl ass w ar e u p o n r ec ei pt a n d b ef or e us e. H ol d t h e gl ass u p t o n at ur al s u nli g ht a n d l o o k f or c hi ps, cr ac ks a n d fr act ur es. E v e n ti n y fr act ur es c a n c a us e t h e gl ass t o b r e a k u n d er pr ess ur e or i n el e v at e d t e m p er at ur es.  
A v oi d b u m pi n g gl ass w ar e a g ai nst a n yt hi n g ( ot h er gl ass w ar e, t h e si d e of t h e si n k, d es kt o p...). T his c a n c a us e ti n y fr act ur es or cr ac ks.  
T o a v oi d d a m a g e t o t h e gl ass, d o n ot s o a k it f or l o n g p eri o ds i n str o n g al k ali n e s ol uti o ns.
bi o c o m
pr o p er cl

At a mi ni m u m, l a b or at ory gl ass s h o ul d b e fr e e of c h e mic al r esi d u e a n d gr e as e. D e p e n di n g o n y o ur ex p eri m e nt, it m a y als o n e e d t o b e st eriliz e d. S o m e ti ps f or cl e a ni n g i ncl u d e:  
Us e a s oft bristl e br us h f or cl e a ni n g t o a v oi d u n n ec ess ar y scr atc h es.  
N e v er us e h y dr ofl u oric aci d ( H F) t o cl e a n gl ass. A m o n g ot h er us es, H F is us e d as a d esc al er, a r ust r e m o v er, a m et al cl e a n er, a gl ass-etc h er a n d a m et al pl ati n g c o m p o u n d.It is hi g hl y c a ustic.  
N e v er us e str o n g al k ali s o a ps or aci ds t o cl e a n gl ass.  
St a n d ar d b or osilic at e gl ass is a ut ocl a v e a bl e. If y o u a ut ocl a v e t h e gl ass, v e nt t h e a ut ocl a v e a n d l et it c o ol sl o wly. A ut ocl a v e at 2 3 0-2 4 0° C. F or s h ort p eri o ds of ti m e ( aft er a n extr e m e us e) it c a n b e a ut ocl a v e d at 4 0 0° C.  
As hi n g gl ass i n m ec h a nic al o v e ns o v er 5 0 0º C f or l o n g p eri o ds of ti m e will s h ort e n t h e lif e of y o ur
bi o c o m
st ai n r e

St ai n R e m o v al S ol uti o n P er m a n g a n at e Mix e q u al p arts of 3 % s ulf uric aci d wit h 3 % h y dr o g e n p er oxi d e Ir o n Mix o n e p art h y dr oc hl oric aci d wit h o n e p art w at er B act eri ol o gic al c o nt a mi n a nt S o a k is disi nf ect a nt s ol uti o n li k e Ci d e x , st e a m a ut ocl a v e, w as h a n d ri ns e W h e n i n d o u bt, r ef er t o M S D S s h e ets f or cl e a ni n g s ol uti o ns t o d et er mi n e if t h e y will r e act wit h c h e mic als o n t h e gl ass w ar e.
bi o c o m
dr yi n g gl

O v e n dr yi n g at 1 0 0° C is b est, b ut r ac k dr yi n g is fi n e.
bi o c o m
st e a m a

A ut ocl a v e b or osilic at e gl ass w ar e f or 1 5 -2 0 mi n ut es at 1 0 0 -1 2 0º C. R e m o v e all cl os ur es, cl a m ps, cl as ps, etc.  
w h e n a ut ocl a vi n g. If it is n ot p ossi bl e t o r e m o v e t h e m, at l e ast l o os e n or u nscr e w t h e m t o a v oi d pr ess ur e b uil d u p.  
Y o u c a n fi n d W PI's c o m pl et e li n e of gl ass w ar e pr o d ucts o n w pic h e mist y.c o m . If y o u h a v e q u esti o ns, pl e as e c o nt act H ei di at 8 6 6. 6 0 6. 1 9 7 4 or h ei di h @ w pii nc.c o m .  
gl ass w ar e.  
T o t est t h at a gl ass c o nt ai n er is f ull y w ett a bl e ( es p eci all y i m p ort a nt w h e n m a ki n g pr ecis e li q ui d m e as ur e m e nts), v erif y t h at distill e d w at er will w et all s urf ac es e q u all y.  
W as h all gl ass w ar e i m m e di at el y aft er us e t o r e m ov e all r esi d u es. If i m m e di at e cl e a ni n g is i m p ossi bl e, s o a k t h e gl ass w ar e.  
N e v er us e wir e br us h es or br us h es wit h a wir e c or e t o cl e a n gl ass w ar e.  
Alc o n o x is t h e b est cl e a n er f or gl ass. H o w e v er, a n o n-a br asi v e dis h s o a p als o w or ks w ell.  
Al w a ys ri ns e cl e a n gl ass w ar e w ell a n d f oll o w wit h a distill e d w at er ri ns e.  
Ci d e x is g o o d bi oci d e.  
R e m o v e gr e as e b y b oili n g t h e gl ass i n a w e a k s o di u m c ar b o n at e s ol uti o n. Or, us e ac et o n e. Ri ns e w ell wit h w at er.  
Ul tr as o nic cl e a ni n g is a n exc ell e nt c h oic e f or gl ass w ar e, es p eci all y w h e n it is c o m bi n e d wit h a h e at e d s ol uti o n of mil d d et er g e nt.  
Gl a s s F a bri c ati o n  
  
C o ati n g D e p o siti o n  
  
  
  
  
A bri s a T e c h n ol o gi e s, a m e m b er of H E F P h ot o ni c s, i s a gl o b all y r e c o g ni z e d t e c h n ol o g y gl a s s f a bri c ati o n a n d o pti c al t hi n fil m c o ati n g c o m p a n y wit h e x p erti s e i n hi g h v ol u m e m a n uf a ct uri n g a n d e n gi n e eri n g c a p a biliti e s, d eli v eri n g T ot al S ol uti o n s t h at pr o vi d e e x c ell e nt p erf or m a n c e, fit n e s s -f or-u s e a n d e c o n o mi e s of s c al e.  
O ur U S b a s e d, st at e -of -t h e-art I S O 9 0 0 1: 2 0 1 5 a n d I T A R  
r e gi st er e d f a ciliti e s i n cl u d e A bri s a I n d u stri al Gl a s s i n S a nt a P a ul a, C A a n d Z C & R C o ati n g s f or O pti c s i n T orr a n c e C A.  
T h e s e t w o di vi si o n s pr o d u c e s ol uti o n s fr o m c ut -t o-or d er c o at e d gl a s s c o m p o n e nt s t o c u st o m c o m pl e x a n d r e a d y-t o-i n st all f a bri c at e d, str e n gt h e n e d, o pti c all y c o at e d, el e ctr o ni c all y e n a bl e d a n d br a n d e d s u b -a s s e m bli e s.  
O ur T ot al S ol uti o n s s er v e a v ari et y of m ar k et s i n cl u di n g Mi cr o -El e ctr o ni c s, D ef e n s e a n d A vi o ni c s, Di s pl a y, I n d u stri al A ut o m ati o n, O pti c al S e n s or s, I m a gi n g, P h ot o ni c s, M e di c al  
& D e nt al, Lif e S ci e n c e a n d m or e.  
  
  
A bri s a I n d u stri al Gl a s s 2 0 0 S o ut h H all o c k Dri v e S a nt a P a ul a, C A 9 3 0 6 0 Z C & R C o ati n g s f or O pti c s 1 4 0 1 A b al o n e A v e n u e T orr a n c e, C A 9 0 5 0 1  
( 8 7 7) 6 2 2 -7 4 7 2 w w w. a bri s at e c h n ol o gi e s. c o m i nf o @ a bri s at e c h n ol o gi e s. c o m
bi o c o m
s o d a -li

Cl e ar & Ti nt e d S o d a -Li m e Gl a s s pr o vi d e s hi g h li g ht tr a n s mi s si o n, c a n b e A R c o at e d f or s u p er hi g h tr a n s mi s si o n, c a n b e c h e mi c all y str e n gt h e n e d, a n d h a s g o o d fl at n e s s.  
S o d a -li m e gl a s s i s t h e m o st pr e v al e nt t y p e of gl a s s a n d i s pr e p ar e d b y m elti n g h e r a w m at eri al s, s u c h a s s o d a, li m e, sili c a, al u mi n a, a n d s m all q u a ntiti e s of fi ni n g a g e nt s i n a gl a s s f ur n a c e at t e m p er at ur e s u p t o 1 6 7 5° C.  
S o d a -Li m e s h e et gl a s s i s m a d e b y fl o ati n g m olt e n gl a s s o n a b e d of m olt e n ti n. T hi s m et h o d gi v e s t h e s h e et u nif or m t hi c k n e s s a n d v er y fl at s urf a c e s.  
S o d a -li m e gl a s s i s t h e b a s e m at eri al f or m o st cl e ar, c ol or e d a n d p att er n e d gl a s s t y p e s.  
  
Di m e n si o n s:  
- T hi c k n e s s e s: 0. 0 2" - 1" ( 0. 5 5 m m - 2 5. 4 m m)  
- Si z e s: U p t o 9 6" x 7 2" ( 2 4 4 0 m m x 1 8 3 0 m m)  
- Ot h er si z e s m a y b e a v ail a bl e u p o n r e q u e st
bi o c o m
s o d a -li

- L e s s E x p e n si v e t h a n ot h er gl a s s wit h s p e ci ali z e d pr o p erti e s s u c h a s b or o sili c at e s a n d al u mi n o silic at e s.  
- S o d a -Li m e gl a s s i s c h e mi c all y st a bl e, pr e v e nti n g c orr o si o n a n d t h er ef or e c h e mi c all y c o m p ati bl e.  
- S o d a -Li m e i s a h ar d gl a s s, s o it h a s s o m e a br a si o n r e si st a n c e, a n d m or e s o if c h e mi c all y str e n gt h e n e d.  
- If h e at t e m p er e d, s o d a-li m e gl a s s c a n b e l e s s v ul n er a bl e t o t h er m al s h o c k.  
- S o d a -Li m e gl a s s i s a g o o d i n s ul at or a s it d o e s n ot tr a n s mit el e ctri cit y w ell d u e t o it s hi g h s p e cifi c r e si sti vit y a n d l o w di el e ctri c c o n st a nt.  
- S o d a -Li m e gl a s s i s hi g hl y tr a n s mi s si bl e m a ki n g it a n e x c ell e nt c h oi c e w h er e li g ht tr a n s mi s si o n i s r e q uir e d.  
A bri s a T e c h n ol o gi e s - 2 0 0 S o ut h H all o c k Dri v e, S a nt a P a ul a, C A 9 3 0 6 0 - ( 8 7 7) 6 2 2 -7 4 7 2 w w w. a bri s at e c h n ol o gi e s. c o m - i nf o @ a bri s at e c h n ol o gi e s. c o m