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Hysteroscopes and Gynecologic LaparoscopesSubmission Guidance for a 510(k) |
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.
(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 |
II. Administrative Information
V. Device Description, Intended Use, and Directions for Use
Appendix B - Hysteroscopic and Laparoscopic Accessories --
List of devices exempt from 510(k)
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
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.
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.
Establishment Registration number
Contact Person and Title
Telephone number and FAX number
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 |
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.
This section identifies the information necessary to evaluate the hysteroscope/laparoscope's 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).
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.
Laparoscope - used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
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.
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.
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.
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.
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.
Provide either:
(Note: Information on the video camera and video monitor should be included if these items are included in the 510(k))
Ratio of luminous energy transmitted to energy delivered.
(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
(1) Total number of pixels
(2) Pixels per square millimeter
(3) Size of pixel (nm)
(4) Active area of CCD chip (mm x mm)
Power or magnification
Focal length (mm)
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.
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.
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:
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 ODE's general requirements for software documentation. You should pay particular attention to the following elements:
Hysteroscopes and laparoscopes that are intended to contact or enter sterile tissue are considered critical devices and, therefore, require sterilization before use.
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.
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.
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
Operative Hysteroscopy
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
Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent:
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:
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:
Warnings
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:
Precautions
Instructions for Use
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.
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 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:
Warnings
Precautions
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
510(K) NUMBER | _____________________________ |
DEVICE NAME | _____________________________ |
PRESENT | ||
DEVICE DESCRIPTION |
YES |
NO |
|
|
|
2. SCHEMATICS, DIAGRAMS |
___ |
___ |
3. MATERIALS (Scope, lens, fibers) |
___ |
___ |
Biocompatibility Test present? |
|
|
SAFETY REQUIREMENTS |
(Fill out information) |
1. THERMAL SAFETY (IEC 601-2-18, Draft)
Scope's exterior surface maximum temperature
(oC) |
_________°C |
|
|
2. ELECTRICAL SAFETY (IEC 601-2-18, Draft)
Leakage current from the eyepiece of laparoscope |
________mA |
COMPONENTS
Proposed device |
Predicate device | |
1. SCOPE |
||
|
|
|
Outer diameter |
________ |
________ |
Channel diameter (If applicable) |
________ |
________ |
2. LIGHT SOURCE |
||
Recommended type of source |
________ |
________ |
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 |
________ |
________ |
C. EYEPIECE (If applicable) |
||
Power of eyepiece (Magnification) |
________ |
________ |
D. WHOLE SYSTEM (Image quality) |
||
Resolution:
|
|
|
Distortion:
|
|
|
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? |
___ |
___ |
SAFETY REQUIREMENTS |
(Fill out information) |
1. ELECTRICAL SAFETY (IEC 601-1 or UL 544) **
|
|
|
|
|
|
ELECTRICAL SAFETY (IEC 601-2-18, Draft) |
|
Leakage current from the eyepiece of laparoscope when electrosurgical devices are used (Recommend not to exceed 50 mA) |
________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(°C) |
________°C |
(Specify location(s)) |
|
Time duration when the maximum temperature is reached (Recommend minimum of 2 hours) |
________hrs |
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 |
________ |
________ |
|
________ |
________ |
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 s corrected by signal processing, provide the resulting, corrected image of the graph paper. |
________ |
________ |
OPTICAL COMPONENTS |
||
A. OBJECTIVE LENS |
||
Focal length (mm) |
________ |
________ |
Field of view (degree) |
________ |
________ |
Direction of view (degree) |
________ |
________ |
B. ILLUMINATION FIBERS |
||
|
________ |
________ |
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 |
________ |
________ |
SOFTWARE DOCUMENTATION (If applicable)
PRESENT | ||
NO |
YES | |
|
|
|
Development |
___ |
___ |
Testing |
___ |
___ |
Results |
___ |
___ |
Verification/Validation |
___ |
___ |
Hazard Analysis |
___ |
___ |
(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
Uploaded on October 28, 1998
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