This guidance was written prior to the February 27, 1997 implementation of 

FDA's Good Guidance Practices, GGP's. It does not create or confer rights for 

or on any person and does not operate to bind FDA or the public. An 

alternative approach may be used if such approach satisfies the requirements 

of the applicable statute, regulations, or both. This guidance will be updated 

in the next revision to include the standard elements of GGP's. 

Hysteroscopes and Gynecologic Laparoscopes 

Submission Guidance for a 510(k) 
FINAL: March 7, 1996 
(Replaces portions of previous: Hysteroscopes and Laparoscopes, Insufflators & Other Related Instrumentation: 
Submission Requirements for a 510(k), dated March 25, 1994) 
Prepared by:  Obstetrics-Gynecology Devices Branch 
Office of Device Evaluation 
Center for Devices and Radiological Health (FDA)  Table of Contents 
I.  Device Identification........................................................................................................ 1
 
A.  Device Name........................................................................................................ 1
 
B.  Predicate Device Name ........................................................................................ 1
 
II.  Administrative Information .............................................................................................. 2
 
III.  Classification ................................................................................................................... 2
 
IV.   514 Special Controls..................................................................................................... 2
 
V.  Device Description, Intended Use, and Directions for Use ............................................... 2
 
A.  Intended Use........................................................................................................ 2
 
B.  Device Description............................................................................................... 3
 
C.  Safety Requirements............................................................................................. 3
 
1.  Thermal Safety ......................................................................................... 3
 
2.  Electrical Safety........................................................................................ 4
 
3.  Electromagnetic Compatibility .................................................................. 4
 
D.  Device Components ............................................................................................. 4
 
E.  Optical Performance............................................................................................. 5
 
F.  Mechanics............................................................................................................ 7
 
G.  Software .............................................................................................................. 7
 
H  Sterilization.......................................................................................................... 8
 
I.  Labeling............................................................................................................. 10
 
A.  Hysteroscopes ........................................................................................ 10
 
B.  Laparoscopes ......................................................................................... 12
 
Appendix A - Comparison Chart 
Appendix B - Hysteroscopic and Laparoscopic Accessories -- List of devices exempt from 510(k)  Page 1 - Hysteroscope and Laparoscope Guidance 
Introduction 
This document outlines the information to be submitted in a 510(k) premarket notification for 
hysteroscopes and gynecologic laparoscopes. For devices that differ significantly from those 
already on the market, FDA may require additional information specific to those differences. 
This document is intended as a companion to the Substantial Equivalence Comparison Chart 
released in April 1995 (see Appendix A), and it replaces our previous March 25, 1994, 
Hysteroscopes & Laparoscopes, Insufflators & Other Related Instrumentation: Submission 
Requirements for a 510(k). 
        
Due to the diversity in their design and intended use, hysteroscopic/laparoscopic accessories (such 
as forceps, electrodes, insufflators, light sources, etc.), are not specifically addressed in this 
guidance document.  However, many of the non-electrical accessories are suitable for Tier-1 
review (see Appendix B).  For more information on the Tier-1 policy, contact the Center for 
Devices and Radiological Health's Division of Small Manufacturers Assistance (DSMA) at 
(800) 638-2041 or (301) 443-6597.  Information about premarket notification requirements for 
insufflators may be found in Hysteroscopic and Laparoscopic Insufflators: Submission Guidance 
for a 510(k), also available from DSMA. 
For more information, contact DSMA or the: 
Obstetrics and Gynecology Devices Branch 

Office of Device Evaluation, HFZ-470 

9200 Corporate Blvd.
 
Rockville, MD 20850 

(301) 594-1180 
I.  Device Identification 
A.  Device  Name 
Provide both the trade and proprietary name of the instrument, as well as the 
common or usual name for the particular type.  Specify whether the device is: 
(i) fiberoptic, electronic video (CCD), or rigid rod-lens, (ii) operative or 
diagnostic, (iii) rigid, flexible, or steerable, and (iv) 2-D or 3-D. 
B.  Predicate Device Name 
Identify the legally marketed devices to which the new device will be compared. 
Be as specific as possible, e.g., proprietary and common name, manufacturer, 
model number, 510(k) reference number, pre-Amendments status, etc.  The 510(k) 
should include a tabbed section with product literature (description, specifications 
& labeling, etc.) for the predicate device.  Page 2 - Hysteroscope and Laparoscope Guidance 
II.  Administrative Information 
Establishment Registration number 
Contact Person and Title 
Telephone number and FAX number 
III.  Classification:  Class II (Special Controls) 
Give the CFR classification regulation number for the device, as well as its classification: 
Device  Class  CFR Reference  ProCode 
 Hysteroscope  II  21 CFR 884.1690  HIH 
 Gynecologic Laparoscope  II  21 CFR 884.1720  HET 
IV.   514 Special  Controls 
Special Controls under 514 of the Act have not been developed for these devices. 
Reference is made in later sections of this guide to voluntary industry standards. 
V.  Device Description, Intended Use, and Directions for Use 
This section identifies the information necessary to evaluate the 
hysteroscope/laparoscopes technological characteristics.   Additional information may be 
required depending on the individual design and function of the device. 
In order to permit an equivalence determination, all of the device characteristics 
and performance data presented in the premarket notification should be compared 
with a legally marketed device whenever possible.  (See the Substantial Equivalence 
Comparison Chart for Laparoscopes, Appendix A). 
A.  Intended Use 
The 510(k) must provide a clear statement of the device's intended use, including 
the indications for use.  Generic intended use statements are listed below: 
Hysteroscope - used to permit direct viewing of the cervical canal and the 
uterine cavity for the purpose of performing diagnostic and surgical 
procedures.  Page 3 - Hysteroscope and Laparoscope Guidance 
Laparoscope - used to permit direct viewing of the organs within the 
peritoneal cavity for the purpose of performing diagnostic and surgical 
procedures. 
B.  Device Description 
1.  System Block Diagram (if applicable) 
2.  Schematics and Diagrams 
Provide diagrams of the hysteroscope or laparoscope, with all key 
dimensions and component materials well marked. Multiple diagrams may 
be necessary to show adequate detail, including key cross-sectional 
diagrams at distal and proximal ends. 
3.  Materials 
A table listing all patient-contacting materials should be provided.  The 
results of biocompatibility testing performed on the finished device, or 
certification that identical materials are used in a legally marketed device 
with a similar intended use, is also required. 
For additional information on biocompatibility, please refer to the Blue 
Book Memorandum Use of International Standard ISO-10993, 
Biological Evaluation of Medical Devices Part 1: Evaluation and 
Testing,  available from the Division of Small Manufacturers Assistance. 
Hysteroscopes are considered limited duration surface devices contacting a 
mucosal membrane or compromised surface.  Laparoscopes are considered 
limited duration external communicating devices contacting 
tissue/bone/dentin. 
C.  Safety Requirements 
1.  Thermal Safety 
Due to the use of high-intensity light sources, temperatures at the distal 
ends of many endoscopes can reach tissue damaging levels.  Please provide 
bench data showing that the device will not present a thermal hazard to the 
patient. This should consist of plots of temperature versus times for several 
key locations on the outside of the endoscope, including the tip.  Testing 
should last at least two hours, and should be conducted in room air with 
the light source set at its maximum intensity setting.  Page 4 - Hysteroscope and Laparoscope Guidance 
The temperature at any patient-contacting part of the endoscope should not 
exceed 41 C, except for the distal tip, which should not exceed 50 C.  If 
the temperature at the distal tip exceeds 41 C, the labeling should include a 
statement warning the user of the potential for thermal injury.  See part 42 
of the draft standard Particular requirements for the safety of endoscopic 
equipment, IEC 601-2-18 (September 1994) for additional details. 
2.	  Electrical Safety 
Hysteroscopes and laparoscopes intended to be used with electrosurgical 
equipment should meet the interconnection test and capacitively coupled 
HF current requirements (part 42.101) of IEC 601-2-18. 
Hysteroscopes and laparoscopes that include an electronic component 
(e.g., video, signal-processing unit) should also comply with the electrical 
shock hazard requirements of IEC 601-2-18. 
3.	  Electromagnetic Compatibility (if applicable) 
Provide either: 
 Certification that the device complies with applicable standards for 
Immunity and Emissions (such as CISPR 11, IEC 601-1-2); or 
 Test results that guarantee a similar level of protection; or 
 Justification for why this information is unnecessary (e.g., due to 
device design or working conditions). 
D.	  Device Components 
1.	  Dimensions 
a.	  Working length 
b.	  Outer diameter 
c.	  Working channel diameter (if applicable) 
2.	  Video camera (if applicable) 
(Note: Information on the video camera and video monitor should be 
included if these items are included in the 510(k)) 
a.	  Number of pixels or lines (horizontal) 
b.	  Number of pixels or lines (vertical) 
c.	  Number of pixels used for color  Page 5 - Hysteroscope and Laparoscope Guidance 
3.	  Video Monitor (if applicable) 
a.	  Monitor size (diagonal size, in inches) 
b.	  Number of lines (horizontal) 
c.	  Number of lines (vertical) 
4.	  Compatible Light Source 
a.	  Type of source (e.g., Quartz, Xenon) 
b.	  Power rating of source (watts) 
5.  Power supply (if a separate power supply unit is part of the system) 
a.	  Type 
b.	  Power requirements (volts, Hz) 
E.	  Optical Performance 
1.	  Objective lens 
a.	  Focal length or working distance (mm) 
b.	  Field of view (degrees) 
c.	  Direction of view from center axis (degrees) 
2.	  Illumination fibers
 Ratio of luminous energy transmitted to energy delivered. 
3.	  Image transmission system (if applicable) 
a.	  Fiberoptic Imaging Systems (if applicable) 
(1)	  Total number of fibers/pixels 
(2)	  Fibers per square millimeter 
(3)	  Size of fiber core (mm) 
(4)	  Area of active fiber per square millimeter 
(5)	  Ratio of luminous energy transmitted to energy delivered  Page 6 - Hysteroscope and Laparoscope Guidance 
b.  Electronic Video Imaging Systems (if applicable) 
(1)  Total number of pixels 
(2)  Pixels per square millimeter 
(3)  Size of pixel (nm) 
(4)  Active area of CCD chip (mm x mm) 
4.  Eyepiece (if applicable) 
Power or magnification 
5.  Coupling Lens (if applicable) 
Focal length (mm) 
6.  System 
a.  Image quality. Provide either: 
Resolution. There are several bar patterns available to use as an 
acceptable method of assessment of device resolution.  These bar 
patterns include the following:  (1) USAF bar pattern, (2) NBS 
1010A Microcopy Test Chart, or (3) ANSI/ISO Test Chart #2. 
The test setup should have the bar pattern on the axis and should 
optimize the magnification and illumination. 
or 
Modulation Transfer Function (MTF).  Provide a description of the 
system MTF over relevant spatial frequencies.  This test setup 
should have the bar pattern on the axis, and should optimize the 
magnification and illumination. 
b.  Distortion characteristics 
Provide information on the distortion introduced by the optical 
system.  As an example, this could be provided by imaging a piece 
of graph paper and providing a comparison of the paper and the 
photographed image of the graph paper.  If the distortion is 
corrected by signal processing, provide the resulting, corrected 
image of the graph paper.   Include a description of the methods 
used to measure distortion.  Page 7 - Hysteroscope and Laparoscope Guidance 
F.	  Mechanics 
The information provided for system mechanics should address changes that occur 
as a result of sterilization and/or any other reprocessing expected during use. 
Provide a description of the mechanics of the laparoscope or hysteroscope, and 
individual mechanical systems, as applicable: 
a.	  Bending mechanism and its controls 
b.	  Fluid delivery system and its controls 
c.	  Any other mechanical systems or controls 
G.	  Software 
Laparoscopes and hysteroscopes that include software are either minor or 
moderate concern devices, depending on the design of the particular device.   The 
guidance document "Reviewer Guidance for Computer Controlled Medical 
Devices"  discusses ODEs general requirements for software documentation. 
You should pay particular attention to the following elements: 
1.	  Description of the software development activities and software quality 
assurance procedures over the software life cycle. 
2.	  System and software requirements and design.  This should include: 
hardware requirements, programming language and program size, and 
software functional requirements.  Traceability between safety 
requirements and hazards should be clearly indicated. 
3.	  Structure chart depicting the partition of the system into functional units. 
4.	  Description of the verification and validation activities at unit, integration, 
and system level, including pass/fail criteria, and the system level functional 
test plan.  Traceability between hazards, safety functions, and testing 
should be demonstrated. 
5.	  Summary of the verification and validation test results in sufficient detail to 
demonstrate that software requirements were met at various levels of 
testing, and the results of system level testing. 
6.	  Current software version number and date, as well as a list of any 
remaining bugs or errors.  Page 8 - Hysteroscope and Laparoscope Guidance 
H	  Sterilization 
1.	  Background 
Hysteroscopes and laparoscopes that are intended to contact or enter 
sterile tissue are considered critical devices and, therefore, require 
sterilization before use. 
2.	  Required Information 
Provide detailed instructions for reprocessing (cleaning and sterilizing) the 
device, including instructions necessary for any assembly/disassembly. 
Also, include a warning that the device should be thoroughly cleaned and 
sterilized according to validated infection control procedures before 
use/reuse. 
a.	  The cleaning instructions should describe careful, manual cleaning 
and rinsing of both the hysteroscope/laparoscopes exterior surface 
and interior channels using a brush and detergent/ enzymatic 
solution to dissolve and loosen proteinaceous materials immediately 
after use.  (Flexible hysteroscopes/laparoscopes require cleaning of 
the suction/biopsy channel in the insertion tube, umbilical cord and 
control head while rigid instruments require careful cleaning of the 
external surface and any internal channels.)  The cleaning 
instructions should identify compatible cleaning solutions by generic 
names (e.g., enzymatic cleaning solutions, protein binding agents, 
etc.) and any areas of the device that are particularly difficult to 
clean, as well as any specified methods and necessary accessories 
(e.g., brushes). 
b. 	 The rinsing instructions should include purging of all internal 
channels (if applicable) alternately with air and water. 
c.	  Leak testing before immersion of the control head of flexible 
hysteroscopes/laparoscopes should be described.  This may be 
either a dry test using a pressure gauge or a wet test that relies on 
evidence of air bubbles when the inflated portion is submerged in 
water. 
d.	  Any liquid steriliants used must be identified and cleared by FDA. 
General reference to a class of germicides, e.g., 2% glutaraldehyde, 
is currently acceptable.  Instructions should recommend that the 
entire endoscope be exposed to the liquid chemical germicide 
according to the labeling of the germicide (appropriate time and  Page 9 - Hysteroscope and Laparoscope Guidance 
temperature).  Liquid sterilization may be manual or automated, 
and, if automated, instructions must identify suitable adapters for all 
interior channels of the hysteroscope/laparoscope. 
e.	  Thorough post process drying instructions should be recommended, 
as needed, in order to reduce recontamination before reuse. 
Instructions should include a step where air is forced through all 
channels following either manual or automated reprocessing to 
remove residual rinse water. 
f. 	 Specify at least one validated method for sterilization and identify 
the specific parameters (e.g., cycle parameters, aeration, specific 
liquid chemical germicide, loading of sterilizer, etc.) which should 
be used.  If the labeling lists a generic type of sterilization process 
with no specifics on cycle parameters, then the applicant must 
validate all forms of the listed generic process, e.g., "steam 
sterilization." 
g.	  Provide information to help the user identify any circumstances or 
conditions when the device may be adversely affected by 
reprocessing.  This information should address the material 
compatibility with the immersion fluid. 
h. 	 Provide a certification regarding validation of the reprocessing 
instructions signed by the applicant, its agent, or other legally 
responsible individual. 
For important additional information on reprocessing, please refer to the 
draft "Labeling Reusable Medical Devices Reprocessing in Health Care 
Facilities: FDA Reviewer Guidance" (March 1995).  A copy of this 
guidance may be obtained from DSMA. 
I.	  Labeling 
A.	  Hysteroscopes 
Indications for Use 
Note:  Hysteroscopes are used as tools for access to the uterine cavity and 
are not, in and of themselves, a method of surgery. 
Diagnostic Hysteroscopy 
	  Abnormal Uterine Bleeding  Page 10 - Hysteroscope and Laparoscope Guidance 
      Infertility & Pregnancy Wastage 
      Evaluation of Abnormal Hysterosalpingogram 
       Intrauterine Foreign Body 
      Amenorrhea 
      Pelvic Pain 
Operative Hysteroscopy 
  Directed Biopsy 
  Removal of Submucous Fibroids and Large Polyps 
  Submucous Myomectomy 
  Transection of Intrauterine Adhesions 
  Transection of Intrauterine Septa 
  Endometrial Ablation 
You may wish to modify this list of indications, particularly for narrow-
gauge hysteroscopes intended to be used in an office setting.  The choice of 
location for hysteroscopy (i.e., office setting vs. hospital) may be altered by 
medical disease, cervical stenosis, and pelvic infection. 
Contraindications for use 
  acute pelvic inflammatory disease 
Hysteroscopy may be contraindicated by the following conditions, 
depending on their severity or extent: 
  inability to distend the uterus 
  cervical stenosis 
  cervical/vaginal infection 
  uterine bleeding or menses 
  known pregnancy 
  invasive carcinoma of the cervix 
  recent uterine perforation 
  medical contraindication or intolerance to anesthesia. 
Contraindications to Endometrial Ablation 
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, 
should not be undertaken without adequate training, preceptorship, and 
clinical experience.  Additionally, endometrial biopsy should be performed 
prior to any ablation.  The following are clinical conditions that can 
significantly complicate hysteroscopic endometrial ablation: 
- Adenomatous Endometrial Hyperplasia 
-Uterine Leiomyoma  Page 11 - Hysteroscope and Laparoscope Guidance 
- Severe Adenomyosis 
- Pelvic Pain (Subtle PID) 
-Uterine anomalies 
Contraindications to Hysteroscopic Myomectomy 
Hysteroscopic myomectomy should not be undertaken without adequate 
training, preceptorship, and clinical experience.  The following are clinical 
conditions that can significantly complicate hysteroscopic myomectomy: 
  Severe anemia 
  Inability to circumnavigate a myoma due to myoma size.
 (e.g., predominantly intramural myomas with small submucous 
components). 
Warnings 
  For use only by physicians trained in hysteroscopy. 
  Suspicion of pregnancy should suggest a pregnancy test before the 
performance of diagnostic hysteroscopy. 
For Continuous Flow Hysteroscopy: 
If a liquid distention medium is used, strict fluid intake and output 
surveillance should be maintained.  Intrauterine instillation 
exceeding 1 liter should be followed with great care to the 
possibility of fluid overload. 
Potential Complications of Continuous Flow Hysteroscopy: 
  Hyponatremia 
  Hypothermia 
  Uterine perforation resulting in possible injury to bowel, 
bladder, major blood vessels, and ureter. 
  Pulmonary edema 
  Cerebral edema  Page 12 - Hysteroscope and Laparoscope Guidance 
Precautions 
	  Vaginal ultrasonography before hysteroscopy may identify clinical 
conditions that will alter patient management. 
	  Intrauterine distension can usually be accomplished with pressures 
in the range of 35-75 mmHg.  Unless the systemic blood pressure is 
excessive, it is seldom necessary to use pressures greater than 
75-80 mmHg. 
Instructions for Use 
  Clinical Use 
  Directions for use, including identification of compatible light 
sources and cables 

  Assembly, disassembly, care & storage 

  Cleaning and Sterilization 

B.	  Laparoscopes 
Indications for Use (Gynecologic Surgery) 
Note:  Laparoscopes are used as tools for access to the abdomen and are 
not, in and of themselves, a method of surgery. 
  Unexplained pelvic pain (acute, chronic) 
  Infertility Work-up 
  Tubal sterilization 
  Diagnosis and/or treatment of ectopic pregnancy 
  Evaluation, diagnosis and/or treatment of pelvic tumors, including 
myomata (less than 16 weeks gestational size) 
  Evaluation of congenital anomalies of the pelvic organs 
  Retrieval of foreign bodies 
  Determination of the presence and extent of pelvic endometriosis 
  Determination of the presence and extent of pelvic inflammatory 
disease (if not in acute stage) 
  Access to abdomen for surgical procedures such as LAVH 
  Visualization, diagnosis and/or treatment of perforate abdominal 
(pelvic) organs 
You may wish to modify this list based on the particular characteristics of 
your laparoscope, particularly for narrow-gauge laparoscopes intended to 
be used in an office setting.  For a more exhaustive list of indications and 
contraindications for gynecologic laparoscopy, refer to the Manual of 
Endoscopy, prepared by the American Association of Gynecologic  Page 13 - Hysteroscope and Laparoscope Guidance 
Laparoscopists (AAGL), as well as other credentialed sources 
Contraindications for Use 
Laparoscopy may be contraindicated by pregnancy greater than 16 weeks 
gestation or abdominal mass of comparable size. 
Laparoscopy may also be contraindicated by the following conditions, 
depending on their severity or extent: 
  Class IV cardiac decompensation 
  Bowel obstruction 
  Ileus 
  Cardiac disease 
  Intraperitoneal hemorrhage 
  Diaphragmatic hernia 
  Infection with acute peritonitis 
  Previous abdominal surgery 
  Obesity 
  Thin nulliparous patient 
  Chronic obstructive lung disease 
  Liver failure with established collateral vessels 
Warnings 
	  For use only by clinicians trained in laparoscopy. 
Precautions 
	  Ultrasonography before laparoscopy may identify clinical conditions 
that will alter patient management. 
	  Abdominal puncture sites 7 mm or greater (for the introduction of 
auxiliary instrumentation) may be a source of herniation. 
	  Lasers and electrosurgical probes should not be activated 
simultaneously.  Further, when one is activated, the tip of the other 
should be completely retracted.  This avoids deflection of the 
energy to the other tip. 
	  The abdomen can be adequately distended by pressure in the range 
of 15-20 mmHg.  It is seldom necessary to use an abdominal 
pressure greater than 20 mmHg.  Page 14 - Hysteroscope and Laparoscope Guidance 
	  During unipolar electrosurgery, inadvertent burns can occur when 
the appropriate patient return path is obstructed or as a result of 
capacitive coupling.  An important maxim: 
Avoid combinations of devices made of both conducting 
and insulating materials, especially metal trocars with 
nonconductive trocar anchors, screws, etc.  That is: "Use 
like with like." 
Instructions for Use 
	  Clinical Use 
	  Directions for use, including identification of compatible light 
sources and cables. 
	  Assembly, disassembly, evaluation, care & storage 
	  Cleaning and Sterilization  Page A-1, SE Comparison Chart 
SE COMPARISON CHART 
A. SIMPLE RIGID ROD LENS 
     
510(K) NUMBER                                                                                                                                     
DEVICE NAME                                                                 
DEVICE DESCRIPTION  YES  NO 
1. SYSTEM BLOCK DIAGRAM        
2. SCHEMATICS, DIAGRAMS        
3. MATERIALS (Scope, lens, fibers)        
Biocompatibility Test present?       
 (If new material) 
SAFETY REQUIREMENTS               (Fill out information) 
 
1. THERMAL SAFETY (IEC 601-2-18, Draft) 
Scope's exterior surface maximum temperature(oC)              oC          (Specify 
location(s)) 
Time duration when the maximum temperature is reached hrs
 (Recommend minimum of 2 hours) 
2. ELECTRICAL SAFETY (IEC 601-2-18, Draft) 
Leakage current from the eyepiece of laparoscope
 when electrosurgical devices are used  mA
   (Recommend not to exceed 50 mA) 
COMPONENTS 
Proposed device  Predicate device 
1. SCOPE 
Working length                               
Outer diameter                              
Channel diameter (If applicable)                               Page A-2, SE Comparison Chart 
Proposed device  Predicate device 
2. LIGHT SOURCE 
Recommended type of source                              
 (e.g. Quartz, Xenon) 

Power rating of source (watts) 
                              
 
OPTICAL COMPONENTS 
 
A. OBJECTIVE LENS 
Focal length (mm)                               
Field of view (degree)                               
Direction of view (degree)                               
B. ILLUMINATION FIBERS 
Ratio of luminous energy transmitted 

to energy delivered 
                               
C. EYEPIECE (If applicable) 
Power of eyepiece (Magnification)                              
  
D. WHOLE SYSTEM (Image quality) 
Resolution:                             
 This information can be provided using various methodologies: 
e.g., USAF bar pattern (line pairs/mm), or

   signal-to-noise ratio versus frequency (db), or

 modulation transfer function (MTF). 

  
Distortion:                              
  
 For example, this could be provided by imaging a piece of

 graph paper and providing a comparison of the paper and the

   photographed image of the graph paper.  If the distortion

 is corrected by signal processing, provide the resulting,

 corrected image of the graph paper. 
 Page A-3, SE Comparison Chart 
B. FIBEROPTIC & ELECTRONIC IMAGING SYSTEMS 
510(K) NUMBER                                                                     
DEVICE NAME                                                                       
PRESENT 
DEVICE DESCRIPTION  YES  NO 
1. SYSTEM BLOCK DIAGRAM         
2. SCHEMATICS, DIAGRAMS        
3. MATERIALS (Scope, lens, fibers)        
   
Biocompatibility Test present?                 
 (If new material) 
SAFETY REQUIREMENTS         (Fill out information) 
1. ELECTRICAL SAFETY (IEC 601-1 or UL 544) ** 
** Applicable if the system has a video component 
    
Enclosure leakage current (mA)  mA 
 
Patient leakage current (mA)  mA
 ELECTRICAL SAFETY (IEC 601-2-18, Draft) 
Leakage current from the eyepiece of laparoscope
 when electrosurgical devices are used  mA
 (Recommend not to exceed 50 mA) 
 
2. ELECTROMAGNETIC COMPATIBILITY (IEC 601-1-2)    
Certification that the device complies with acceptable standards 
for Immunity and Emissions (i.e., CISPR 11, IEC 601-1-2), or 
test  results which guarantee a similar level of protection, or 
a justification of why this information is unnecessary 
(e.g., due to device design or working conditions). 
3. THERMAL SAFETY (IEC 601-2-18, Draft) 
 
Scope's exterior surface maximum temperature(oC)             oC 
(Specify location(s)) 
Time duration when the maximum temperature is reached  hrs
 (Recommend minimum of 2 hours)  Page A-4, SE Comparison Chart 
COMPONENTS 

(Fill out information) 
Proposed device     Predicate device 
1. SCOPE 
Working length                               
Outer diameter                               
Channel diameter (If applicable)                               
2. VIDEO CAMERA (If applicable) 
Number of pixels or lines - Horizontal                                
Number of pixels of lines - Vertical                                
Number of pixels used for color                                
3. VIDEO MONITOR (If applicable) 
Number of lines - Horizontal                               
Number of lines - Vertical                               
4. LIGHT SOURCE 
Type of source (e.g., Quartz, Xenon) 
                               
Power rating of source (watts) 
                               
6. WHOLE SYSTEM (Image quality) 
        
Resolution:                             
 This information can be provided using various methodologies: 
e.g., USAF bar pattern (line pairs/mm), or
   signal-to-noise ratio versus frequency (db), or
 modulation transfer function (MTF). 
 
Distortion:                               
  
 For example, this could be provided by imaging a piece of

 graph paper and providing a comparison of the paper and the

 photographed image of the graph paper. If the distortion 

is corrected by signal processing, provide the resulting,

 corrected image of the graph paper. 
 Page A-5, SE Comparison Chart 
OPTICAL COMPONENTS 
Proposed device     Predicate device 
A. OBJECTIVE LENS 
Focal length (mm)                                
Field of view (degree)                                
Direction of view (degree)                                
B. ILLUMINATION FIBERS 
Ratio of luminous energy transmitted

 to energy delivered 
                              
C. IMAGING TRANSMISSION SYSTEM (Fiberoptic or Electronic) 
FIBEROPTIC IMAGING TRANSMISSION

 Total number of fibers
                               
 Fibers per square millimeter
                              
 Size of fiber core (mm)
                                
 Area of active fiber per square 

millimeter
                               
   Ratio of luminous energy transmitted 

to energy delivered 
                               
ELECTRONIC IMAGING TRANSMISSION 
 Total number of pixels                              
  Pixels per square millimeter                              
 Size of pixel (micron)                              
 Active area of CCD imager (mm x mm)                               
D. EYEPIECE (If applicable) 
Power of eyepiece (Magnification)                               
E. COUPLING LENS (If applicable) 
Focal length (mm)                               
Focal number                                Page A-6, SE Comparison Chart 
SOFTWARE DOCUMENTATION (If applicable) 
PRESENT 
YES  NO  
Design        
Development        
Testing        
Results        
Verification/Validation        
Hazard Analysis         Page B-1    Laparoscopic and Hysteroscopic Accessories -- Exempt 
Laparoscopic and Hysteroscopic Accessories 
List of Exempt Devices 
(From Federal Register Notice 1124, January 16, 1996) 
Effective February 16, 1996, the following laparoscopic and hysteroscopic accessories are exempt 
from the 510(k) premarket notification procedures, if they are not part of a specialized instrument or 
device delivery system,  and if they do not have adaptors, connectors, channels,  or other portals for 
electrosurgical, laser, or other power sources. 
lens cleaning brush 
biopsy brush 
clip applier (without clips) 
cannula (without trocar or valves) 
ligature carrier/needle holder 
clamp/hemostat/grasper 
curette 
instrument guide 
ligature passing and knotting instrument 
suture needle (without suture) 
retractor 
mechanical (non-inflatable) snare 
stylet 
forceps 
dissector 
scissors 
suction/irrigation probe