Custom 3-D Printed Noninvasive Ventilation Mask
Phase: NA
Conditions: Sleep Apnea, Pediatric Sleep Apnea
Sponsor: Children's Hospital Medical Center, Cincinnati

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Cover Page 
 
 
 
 
 
 
Title: Custom 3-D Printed Noninvasive Ventilation Mask  
 
NCT: NCT02896751 
 
Protocol Version: 09Sep2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title of Study: Custom 3-D Printed Noninvasive Ventilation Mask  
 
Principle Investigator: Narong Simakajornboon, MD 
Co-investigators/advisors: Geoffrey Rulong, MD, John van Aalst MD, Stacy Gruber BS,  
 
 
1. 
ABSTRACT 
Studies have shown that even though noninvasive ventilation (NIV) with positive airway 
pressure (PAP) is successful at treating obstructive sleep apnea and hypoventilation, individuals 
have poor compliance with therapy1-2.  The reasons for poor compliance are numerous, but one 
significant and continually reported reason is poor mask fit.  A poor mask fit is not only 
uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation 
and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around 
the mask.   Pediatric patients tend to be especially difficult to fit with conventional masks 
because of their smaller facial features and the lack of masks developed for pediatric use.  This 
difficulty is increased significantly for pediatric patients, who more commonly require positive 
pressure ventilation, due to craniofacial abnormalities and neuromuscular disease.  
 
In this study, patients will be fitted with a custom made NIV mask following facial imaging with a 
three dimensional (3D) camera (Artec 3-D scanner).  The facial image will be used to construct 
a NIV mask model using computer design software (Blender) that will then be created by using 
a 3D printer (Stratasys Objet).    
 
Patients enrolled in the study will be recruited from the pediatric sleep clinic at Cincinnati 
Children’s Hospital Medical Center who have been stable on their current noninvasive 
ventilation settings, with the same mask, for a minimum of 2 months.   Study visits will be 
conducted during regularly scheduled clinic visits and data will be collected on their compliance 
by downloading the information from their home ventilation equipment.  Three questionnaires 
that are routinely given at every clinic visit: Pediatric Quality of Life Inventory (PEDS QOL), 
Epworth Sleepiness Scale (ESS) and the Pediatric Sleep Questionnaire (PSQ), as well as an 
additional questionnaire developed at CCHMC asking quality of life and subjective compliance 
data will also be collected at each visit.  Patients will be followed for 6 – 9 months following their 
mask change to determine if the custom made mask decreased side effects while increasing 
ventilation and compliance.   
 
 

Protocol_v. 09Sept2016 
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2. 
PURPOSE OF STUDY 
The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by 
decreasing the side effects commonly seen with noninvasive ventilation.  To our knowledge, 
there have been no prospective studies to determine if three dimensional imaging of a subject’s 
face can be analyzed to create a personalized 3D printed noninvasive ventilation mask. 
 
It is hypothesized that a better fitting customized mask, using 3-dimensional imaging 
technology, will lead to increased comfort and better ventilation by decreasing the air leak and 
residual apnea-hypopnea index.  The improved ventilation, increased comfort and fewer side 
effects will, in return, lead to improved adherence in our subjects.  To study this question, we 
will recruit patients seen in the CCHMC Sleep Center Clinic.  Side effects, patients’ quality of life 
and adherence will be measured by having participants complete questionnaires and 
downloading ventilator data, respectively, during study visits.   
 
If the use of three dimensional technologies to create a noninvasive ventilation mask is found to 
improve residual leak, residual AHI and patient adherence, this study has the potential to benefit 
countless other patients.     
 
 
3. 
BACKGROUND 
Noninvasive ventilation (NIV) methods such as continuous positive airway pressure (CPAP) and 
Bi-level positive airway pressure (BiPAP) are beneficial therapies for obstruction sleep apnea 
(OSA) and nocturnal hypoventilation respectively3-5.  If untreated or undertreated, OSA and 
nocturnal hypoventilation can lead to negative effects on patients’ overall health and quality of 
life (6-7).  Following diagnosis and initiation of NIV, adherence to therapy, defined as using NIV 
for greater than 4 hours per night, varies from 50% to 80%1.  At Cincinnati Children’s Medical 
Center adherence to NIV is approximately 50%.  Prior studies have shown that there is no 
difference in the mode of therapy and adherence1-2.  A common reason reported for poor 
adherence is related to mask fit: comfort, skin breakdown and leaks.  Additional complaints that 
are frequently reported with NIV include nasal congestion or dryness, abdominal discomfort and 
burping1-2.   However, studies have shown that individuals, who have better ventilation with an 
increased reduction in their residual number of apneas and hypopneas, following NIV initiation, 
are more compliant1.   
 
 
4. 
STUDY DESIGN 
This will be a prospective pilot study to determine if the use of 3D technologies to create a 
customized computer designed NIV mask will improve ventilation and comfort, resulting in 
improved adherence in patients requiring PAP.  Patients, who have been stable on noninvasive 
ventilation for at least 2 months will be recruited from Cincinnati Children’s Medical Center sleep 
clinic.    
 
All study visits will be incorporated into regularly scheduled clinic visits. On their first study visit, 
the clinical conventional mask fitting, done in a standardized fashion by a professionally trained, 

Protocol_v. 09Sept2016 
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experienced respiratory therapist, nurse or physician will be reviewed.  During this visit, 3D 
facial imaging will be obtained using an Artec 3D Scanner (Artec Group, San Diego, Ca, USA).  
The clinically obtained baseline self-assessment data of the participants’ sleep related breathing 
disorders (SRBD) and symptom complexes, such as hyperactivity, sleepiness, and inattention 
will be reviewed through the Michigan Pediatric Sleep Questionnaire (PSQ), Epworth 
Sleepiness Scale (ESS), Pediatric Quality of life Inventory (PedsQL) and CPAP follow up 
questionnaire when available.  It is standard practice to have patients complete such 
questionnaires at all CCHMC Sleep Disorders Center follow up visits.  Objective, compliance 
and ventilation data will also be collected clinically and reviewed during the initial visit by 
evaluating the meter readings on the patient’s home assisted ventilation machines, which is 
standard practice at follow-up visits in the CCHMC CPAP clinic.  
 
Facial images obtained using the Artec 3D scanner will be examined with Blender software to 
analyze the subject’s facial contours in order to create a 3D printed customized mask. A 
Stratasys Objet 3D printer, using the PolyJet method with bio-compatible material (Polylactic 
acid (PLA) filament) , will then be used to create the rigid portion of the mask.  Smooth-on 
EcoFlex material will then be attachment to the rigid portion of the mask in order to interface 
with the subject.  At the second clinic visit, which will be a regularly scheduled visit, the 
participants will be provided with the mask created using the imaging software and this mask 
will be sent home to be worn by the participant while asleep.  The clinically acquired self-
assessment data such as PSQ, ESS, PedsQL and CPAP questionnaires and clinically obtained 
compliance data from the PAP machine will be reviewed.  
 
The third and subsequent visits will also be regularly scheduled follow up visits, which occur 
approximately every 3 months.  As part of the clinical care at each of these visits, participants 
routinely complete the PSQ, ESS, PedsQL and CPAP follow up questionnaires and objective, 
compliance and ventilation data is downloaded from the meter readings of the PAP machine.  
These data will be reviewed.   
 
 
5. 
DURATION 
This study will last about 18 months with patient recruitment being in the first 3 - 6 months. 
Subject participation will last about 9 months with first two visits and the remainder of the visits 
to allow for approximately 6 months of using the test mask.  
 
 
6. 
SELECTION AND RECRUITMENT OF PARTICIPANTS 
A. Number of patients: 
We plan to enroll about 15-20 subjects  
B. Inclusion / Exclusion criteria 
Inclusion – patients aged 5 – 25 years of any race or socioeconomic background who 
have been stable on NIV settings for a minimum of 2 months for any reason.   
 
Exclusion – new diagnosis or not on stable NIV settings. 
C. Recruitment 

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Participants will be recruited from Cincinnati Children’s Medical Center Sleep Disorders 
Clinic.  Potential study participants will be identified by study physicians at the time of 
their clinic visit to discuss the trial and possible enrollment.  Interested, eligible 
candidates, who are willing to be enrolled and give informed consent, will then be 
enrolled in the study during the clinic visit.   
Any recruitment materials used will be submitted to the IRB for approval prior to use.   
 
 

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D. Vulnerable Populations 
For subjects under 18 years of age, additional efforts will be made to protect this 
vulnerable population. Assent will be obtained after age appropriate explanation of the 
study is completed.  The child will be informed that participation in this clinical trial is 
voluntary and that they may decline or withdraw at any time, for any reason, 
independent of their parent or legal guardian.  Assent will be reaffirmed before any study 
procedures are performed. Participants will be informed that participation in this trial will 
not affect their clinical care in the Sleep Disorders Center. 
 
 
7. 
PROCESS OF OBTAINING CONSENT 
The participant or the participant and his or her parent/legal guardian will be given the consent 
form for the study.   The form will be reviewed with the participant and his or her parent/legal 
guardian with time given for questions.  The subject will sign assent, as determined by the IRB, 
and their parent or legal guardian will sign consent after all questions have been answered.  If 
participants are 18 years of age or older they will sign the consent form themselves after all 
questions have been answered.  A signed copy of the consent form will be given to the subject 
and their legal guardian to keep.  The participant will be informed that this research trial is 
voluntary and that they are free to withdraw at any time.  All participants who are of age to 
assent for this study, as determined by the IRB, and those consenting will sign after all 
questions are answered.  No study related procedures will be done prior to the assent and 
consent forms being signed.  
 
To provide a consent form in understandable language, the CCHMC approved consent form 
template will be used.  Any non-English speaking participants, enrolled in the study, will be 
consented using a short form consent process as per CCHMC SOP 41-1.8. The approved long 
consent form will serve as the summary of the research. 
 
 
8. 
STUDY PROCEDURES 
Review of medical records: a review for inclusion/exclusion criteria will be completed by a 
member of the research team prior to enrollment in the study.   Review of medical records will 
continue throughout the study to document changes in health during subject’s participation. 
 
Informed Consent: informed consent will be obtained by a member of the research team at a 
regularly scheduled clinic visit.  Participants and their parent/legal guardian will be informed at 
their clinic visit that approximately 30 to 45 minutes, beyond the routine clinical care, will be 
required during this visit.  The additional time will be used to review the procedures and goals of 
the study, review the informed consent and/or assent forms, answer questions the participants 
or their legal guardians have regarding the study.   
 
Imaging: facial imaging will be obtained using a 3D camera (Artec 3-D scanner) for three-
dimensional re-creation of facial contours.  This will take about 10 minutes and will occur in the 
pre-determined imaging room within the clinic space.    

Protocol_v. 09Sept2016 
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Questionnaires: participants will complete as part of their clinical visits the Michigan PSQ, 
ESS, and PedsQL questionnaires, which is standard clinical practice for all patients seen in the 
sleep center.    In addition to the standard questionnaires, participants will be asked to complete 
a CPAP follow up questionnaire (CFU) that will be used to measure comfort and side-effects of 
NIV at each visit as well. The results of the clinical questionnaires will be used for this research. 
If a questionnaire is not collected during the clinical visit, it will be recorded as missing in the 
research record. 
 
Ventilation machine download: a review of the participants NIV machine data, which is 
standard practice at each clinical visit, by a professionally trained respiratory therapist, nurse or 
physician will be completed.  The data obtained will be used to evaluate compliance, mask leak 
and residual apnea-hypopnea index will occur at each visit. If the participant does not bring their 
PAP machine to their clinical visit, the downloaded data will be recorded as missing in the 
research record. 
 
Mask creation: facial images of the participants, using the Artec three dimensional surface 
scanner will be examined using Blender software, to analyze their facial contours described 
below, located in the surgery clinic at CCHMC and in Dr. Chia-Ying Lin’s laboratory at the 
University of Cincinnati Bioengineering Department.  A NIV mask will then be created at the 
University of Cincinnati using a Stratasys Objet machine’s PolyJet method out of bio-compatible 
material (Polylactic acid (PLA) filament Smooth-On’s Ecoflex silicone will then be attached to 
the ridged portion of the mask to interface with the subject. 
 
Participants will then be provided, without charge, their customized mask to wear exclusively 
throughout the duration of the study.  All masks will be compatible for use with the participant’s 
home health supplied equipment and fitted by a professionally trained respiratory therapist, 
nurse or physician during the visit.   The mask will be created to be compatible with the tubing 
and elbow used for the Respironics Wisp mask, which has built in, FDA approved exhalation 
ports to allow for continuous airflow out of the mask.   
 
The number of study visits will vary and be determined by each subject’s scheduled clinic visits.  
It is planned that subjects will be followed, during regularly scheduled follow up visits, for 
approximately 12 months after mask selection.  At these subsequent visits, subjects will 
complete the Michigan PSQ, ESS, PedsQL and CFU questionnaires.  Objective, compliance 
data will be reviewed by downloading their home ventilation machine’s meter readings and they 
will be refitted with their mask by a professionally trained respiratory therapist, nurse or 
physician (all of which are standard practice for clinic follow up visits besides the CFU 
questionnaire).     
 
 

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Visit 1 
Visit 2 
Visit 3 
Visit X (regularly 
scheduled clinic visitis up 
to 18 months post V1) 
Sign informed consent 
R 
  
  
  
Given Customized mask 
R 
  
  
Conventional mask fitting process 
C 
C 
C 
  
3D Imaging photos  
R 
R 
R 
R 
Questionnaires: Michigan PSQ, Epworth 
ESS, PedsQL, CPAP follow-up 
questions 
C 
C 
C 
C 
Download CPAP machine use readings 
C 
C 
C 
C 
Review of medical records  
C 
C 
C 
C 
Adverse Events assessment 
  
R 
R 
R 
C = clinical     R = Research 
 
Custom Noninvasive Ventilation Masks:  
We feel the use of this custom mask may fall under the FDA regulations 21CFR812.3(b) 
Custom Devices because we feel it meets the following requirements. If the IRB determines, we 
will submit this as a device without significant risk under the FDA regulations 21CFR812.2(b)1 
abbreviated requirements.  
Custom device defined by FDA: 
(1) Necessarily deviates from devices generally available or from an applicable 
performance standard or premarket approval requirement in order to comply with the 
order of an individual physician or dentist; 
(2) Is not generally available to, or generally used by, other physicians or dentists; 
(3) Is not generally available in finished form for purchase or for dispensing upon 
prescription; 
(4) Is not offered for commercial distribution through labeling or advertising; and 
(5) Is intended for use by an individual patient named in the order of a physician or 
dentist, and is to be made in a specific form for that patient, or is intended to meet the 
special needs of the physician or dentist in the course of professional practice. 
 
NIV masks created for use during this study will be similar to those that are commercially 
available and clinically used at the CCHMC Sleep Center.  At the time of study initiation, 
participants will have already been using a CCHMC provided NIV mask, with stable settings, for 
a minimum of 2 months.   
 
The goal of the 3-dimensionally created custom mask is to increase patient comfort, and 
decrease common side effects such as air leaks, skin irritation, dry mouth, congestion, 
rhinorrhea, sneezing, nosebleeds and stomach discomfort.  As a result of decreasing side 
effects, we hypothesize that adherence will be improved.   
 
The mask will be 3D printed using the PolyJet method (see below) of a Stratasys Objet printer 
using the bio-compatible material MED610 (see below).   A silicone gel attachment (Smooth-on 

Protocol_v. 09Sept2016 
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Ecoflex), which is standard on commercially produced NIV masks, will then be placed on the 
mask to directly interface with the subject. 
 
The personalized mask will be compatible with the FDA approved Respironics Wisp mask 
tubing and elbow that can be connected to the subjects NIV machine.  The choice of the Wisp 
mask tubing and elbow was made because it has built in exhalation ports that allow for a 
continuous flow of air out of the mask.   
 
Hardware for Creating a Customized NIV Mask: 
• 
3-Dimensional Surface Imaging:  three dimensional surface scans of participant’s 
faces will be obtained using an Artec 3D Scanner (Artec Group, San Diego, CA, USA).  
The Artec 3D Scanner uses fringe projection, light based imaging technology to obtain 
360 degree images.  The resolution is up to 0.5 mm with point accuracy of 0.1 mm.  
Exposure times are 0.2 milliseconds.  The scanner’s software produces images that will 
be analyzed with standard software described below.  The speed and location of this 
scanner will allow investigators to collect images in the clinical setting quickly and will 
eliminate the limitations of a two dimensional imaging system.  
• 
Software for Creating a Customized NIV Mask: the Artec 3D Scanner images will be 
analyzed with Blender software (Amsterdam, Netherlands) as follows.  The subject’s 
facial scan will be aligned in the anterior and profile views.  Points along the contour of 
the subjects face will then be selected and the distance between the selected points will 
be measured, in millimeters, to create the outline for an appropriate mask mold using 3D 
printing.   
• 
Objet 3D printer (Stratasys, Eden Prairie, MN, USA): uses PolyJet technology to layer 
and cure, using UV light, liquid photopolymer to create an accurate 3D mask.   
• 
Bio-compatible PolyJet photopolymer (Polylactic acid (PLA) filament: a rigid 
medical rapid prototyping material. A biocompatible material that is used in many 
medical devices1.  It will be used in the three-dimensional printing process to create the 
rigid portion of the mask.  12. 
• 
Ecoflex® (Smooth-on, Macungie, PA, USA): platinum-catalyzed silicone that is 
versatile and easy to use. Cured material is certified by an independent laboratory to 
ISO 10993-10, Biological evaluation of medical devices, Part 10: Tests for irritation and 
skin sensitization.13 
 
Questionnaires:  
• 
Pediatric sleep questionnaire (PSQ) – 22 question screen, completed by the patient’s 
parent, for sleep-disordered breathing, snoring, sleepiness and behavioral problems in 
subjects 2 – 18 years of age that was developed by researchers at the University of 
Michigan.  It was shown to be valid and reliable in identifying sleep related breathing 
disorders by Chervin et al in 200011.   
• 
Epworth Sleepiness Scale (ESS) – scale used to measure daytime sleepiness using 8 
questions.  It has shown reliability and been validated in the diagnosis of obstructive 
sleep apnea in adult patients and a modified version has been used frequently in 

Protocol_v. 09Sept2016 
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pediatric patients, but has yet to be validated.  It is used frequently during follow up visits 
after initiating NIV to evaluate for improvement of symptoms14.   
• 
Pediatric Quality of life Inventory (PedsQ) – used to measure health related quality of 
life in children and adolescents aged 2 – 18 years.  It has been shown to be reliable and 
valid in a study published by Varni et al in 200115.   
• 
CPAP Follow Up Questionnaire (CFU): The items included in this questionnaire are 
often reviewed with patients during their sleep clinic visits regarding side-effects, 
comfort, problems encountered with CPAP use and their adherence to treatment.  It has 
not been validated but is solely being used to collect information in a standardized 
format. 
 
 
9. 
DATA ANALYSIS/METHODS 
Descriptive analyses will include calculation of mean (SD), median and range for each 
continuous variable and n (%) for each categorical variable. Primary outcomes include 
adherence rates, as measured by machine-based compliance.  We will compare self-reported 
adherence to machine-reported adherence using Bland-Altman analyses and correlation 
coefficients (Pearson’s r). This comparison will be performed on paired data at each visit and on 
the overall average for each subject across multiple visits. Data will be transformed to achieve 
normality as needed. Appropriate linear mixed models will be used to assess change in 
outcome over time, with adjustment for within-subject correlation and any multiple comparisons 
made across visits. Analyses will be performed using SAS 9.3. 
 
Power analysis – For this pilot study, planned enrollment is between 15-20 subjects, and we 
assume the potential for 10% attrition from baseline to the first follow-up assessment. We have 
sufficient power (80-92%) to detect a 10% increase in compliance, given a level of 50% 
compliance at baseline and the aforementioned enrollment and attrition. Our analysis is based 
upon percentage of time mask is used as directed for each subject, as recorded by the 
machine. Actual data acquired on this percentage outcome will be transformed to achieve 
normality. For the power analysis, we assume SD is 0.12 from baseline to follow-up visit, using 
a paired t-test with two-sided alternative and alpha=0.05.  
 
 
10. 
FACILITIES AND PERFORMANCE SITES 
All participants will be recruited from and followed up in the CCHMC Sleep Disorders Center 
Clinic, located in Building C.   
Dr. Chia-Ying Lin’s laboratory at the University of Cincinnati Bioengineering Department will be 
used to manufacture the custom mask. 
3D Imaging will be done in the Surgery Clinic on C2. 
 
 
11. 
POTENTIAL BENEFITS 
We feel this study offers the potential of direct benefit to participants. It is hypothesized that 
participants will have improved adherence with their NIV which can be attributed to a more 

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comfortable and better fitting mask.  Secondary goals would be improving the patient’s quality of 
sleep, decreasing daytime sleepiness, increasing energy levels and an overall improvement in 
their quality of life.  If this personalized 3 dimensional creation of a NIV mask does improve 
patient adherence and comfort levels, this study will likely benefit countless other patients by 
providing them with an optimal mask that more appropriately fits their face.  
 
 
12. 
POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES AND PRECAUTIONS 
We anticipate there is no difference between a custom mask and a commercial mask other than 
better fit and greater comfort. We recognize that there may be other risks that we do not know 
about yet. One potential risk could be the rebreathing of exhaled air.  To address this possible 
risk, we will use the FDA approved elbow and tubing from the Respironics Wisp mask that has 
exhalation ports built into the elbow, which directly connects with the mask.  Additionally for this 
study, only nasal masks will be created; allowing for subjects to exhale through their mouths as 
well.  Patients will also trial the mask in a supervised clinical setting prior to going home to 
monitor for any difficulties they have tolerating the mask.  We will monitor for adverse events 
that include report of increase in headaches, particularly on waking; increase restlessness or 
awakenings during sleep; difficulty breathing with the mask; and increased tiredness. 
 
The risk to participant privacy would be accidental release of protected health information.  To 
limit this risk, we will remove all patient identifiers at the time of data entry into a secure, 
password protected database maintained by the PI.  Any accidental disclosure of patient health 
information will be conveyed to the CCHMC IRB as a reportable event. 
 
Patients enrolled in this study will only be seen during regularly scheduled clinic visits.  Extra 
time spent during the initial visit for this study will be approximately 5 to 10 minutes to obtain 
imaging and an additional 30 to 60 minutes for the fitting and trial of custom mask on Visit 2.   
 
 
13. 
RISK/BENEFIT ANALYSIS 
This study has minimal risk with potential direct benefit to the participants and to future patients.  
 
 
14. 
DATA SAFETY AND MONITORING 
The primary investigator will review all adverse events and determine causality. This study 
defines expected adverse events in the risk section and these will be reported at time of 
continuing review in table format.  Reportable events (RE) will be defined for this study as any 
adverse event (injury or unexpected outcome) related to study procedures or use of 
interventional masks that are not listed in the risks above.  RE and accidental release of 
protected health information will be reported to the IRB in a timely manner.  
 
 
 
 

Protocol_v. 09Sept2016 
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15. 
PRIVACY AND CONFIDENTIALITY 
All participants enrolled in this study will be assigned a unique study number. Protected health 
information other than dates of visits, dates of tests and dates of birth will not be entered into the 
database.  Images taken for 3D scans will be maintained on the proprietary software of the 
Artec 3D Scanner. Hard copies of images captured as part of this study will be labeled and 
stored with the following information: study ID, date and visit number. The images will be shared 
with UC bioengineering team who are involved in this study and part of Dr. Lin’s laboratory but 
will be identified by Study ID number, visit number and date. A Data Use agreement will be 
obtained if the IRB determines it is needed.   
 
The code linking medical record number to study number will be kept in a secure manner and 
access restricted to the research team.  All computerized records will be kept on the password 
protected CCHMC secure network.  
 
Future Research: 
Data and images may be used for future research studies by the PI and Co-Investigators for 
subjects who give consent for future research.  
 
The results of this study may be published and presented to the public for educational purposes.  
No information that could identify a subject will be used in any publication or presentation.   
 
 
16. 
COST OF PARTICIPATION 
No participants or third party payers will be billed for time spent or imaging related to their study 
visits.  Participants and third party payers will not be billed for the mask selected by 3D imaging. 
There will be no cost incurred to the patient’s and their families for this study in relation to travel 
(fuel and time off work) and parking because participants will be seen during regularly 
scheduled follow up visits in the sleep clinic.   
 
 
17. 
PAYMENT FOR PARTICIPATION  
No payments will be provided for participation 
 
 
18. 
INVESTIGATOR RESPONSIBILITIES 
The investigators will comply will all relevant requirements of 21 CFR 820.30 as determined in 
document FDA Device Advice: Investigational Device Exemption (IDE) 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourD 
 
 
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Pediatrics 2007: 120; e1203 – e1211.  

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