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Hysteroscopic And Laparoscopic Insufflators: Submission Guidance For A 510(K) (Text Only)

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.

DRAFT: August 1, 1995
                                  
(Replaces portions of previous :"Hysteroscopes & 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

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
     Device Name . . . . . . . . . . . . . . . . . . . . . . . . . .1
     Predicate Device Name . . . . . . . . . . . . . . . . . . . . .1
     Establishment Registration. . . . . . . . . . . . . . . . . . .1
     Classification. . . . . . . . . . . . . . . . . . . . . . . . .1
     Performance Standards . . . . . . . . . . . . . . . . . . . . .2

Laparoscopic Insufflators. . . . . . . . . . . . . . . . . . . . . .3
     Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . .3
     Description of Insufflator. . . . . . . . . . . . . . . . . . .3
          Physical and/or Electronic Description . . . . . . . . . .3
          Full Listing of Performance Specifications . . . . . . . .4
          System Level Hazard Analysis . . . . . . . . . . . . . . .5
          Software . . . . . . . . . . . . . . . . . . . . . . . . .5
          Electrical safety. . . . . . . . . . . . . . . . . . . . .6
          Electromagnetic compatibility. . . . . . . . . . . . . . .6
     Comparison Table. . . . . . . . . . . . . . . . . . . . . . . .7
     Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Hysteroscopic Insufflators . . . . . . . . . . . . . . . . . . . . .9
     Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . .9
     Description of Insufflator. . . . . . . . . . . . . . . . . . .9
          Physical and/or Electronic Description . . . . . . . . . .9
          Full Listing of Performance Specifications . . . . . . . 10
          System Level Hazard Analysis . . . . . . . . . . . . . . 12
          Software . . . . . . . . . . . . . . . . . . . . . . . . 12
          Electrical safety. . . . . . . . . . . . . . . . . . . . 13
          Electromagnetic compatibility. . . . . . . . . . . . . . 13
     Comparison Table. . . . . . . . . . . . . . . . . . . . . . . 13
     Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . 13
          Gas Hysteroscopic Insufflation . . . . . . . . . . . . . 13
          Liquid Hysteroscopic Insufflation. . . . . . . . . . . . 15

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


Introduction

This document outlines the information to be submitted in a 510(k) 
premarket notification for hysteroscopic and laparoscopic insufflators.   
For devices that differ significantly from those already on the market, 
FDA may require additional information specific to those differences.   

This guidance represents a greatly expanded version of our previous 
guidance on insufflators, which was included in the March 25, 1994, 
"Hysteroscopes & Laparoscopes, Insufflators & Other Related 
Instrumentation: Submission Requirements for a 510(k)".


I.   Device Name 

     Provide both the trade or proprietary name of the instrument, as 
well as the common or usual name for the particular type, and specify (i) 
hysteroscopic or laparoscopic and (ii) gas or liquid.  
          

II.  Predicate Device Name

     Identify the legally marketed device(s) 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, labels & labeling, etc.) on the 
predicate device.


III. Administrative Information    

     Establishment Registration #
     Contact Person and Title
     Telephone number and FAX number


IV.  Classification:     Class II (Special Controls)

     Give the CFR classification regulation number for the device, as 
well as its classification:


     Device                   Class          CFR Reference

       Hysteroscopic 
          Insufflator              II        21 CFR  884.1700
       Laparoscopic
          Insufflator              II        21 CFR  884.1730



V.     514 Performance Standards:  None Applicable

     Performance standards 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.


Laparoscopic Insufflators

I.   Intended Use

     Identify the intended use of the device, being as specific as 
possible.  For example:

          This device is intended to facilitate the use of the 
laparoscope by filling the peritoneal cavity with gas to distend it (21 
CFR   884.1730).
          

II.  Description of Insufflator

     A.   Physical and/or Electronic Description
               
          1.   Provide a diagram illustrating the flow of gas from its 
source to the exit port of the scope.  Include all safety features, 
filters., and any special features, such as a gas warmer.

          2.   Indicate whether the device regulates and/or displays each 
of the following parameters:

                                   Displays       Regulates

               Intra-abdominal Pressure                                                                   

                   
               Flow Rate                                                   


               Volume Delivered                                                 

          3.   Distension Media 
          
               a.   What is the gaseous distension medium? 
               b.   What is the source of the medium? 
               c.   If the device can be used with either CO2 or N2O, 
describe the necessary calibration procedures and the connector indexing 
system.

          4.   Filter (If applicable)
          
               Use of a hydrophobic filter between the patient and the 
insufflator to prevent patient cross-contamination is highly recommended.  
The following specifications for the filter should be provided:  

               a.   pore size (0.2 micron or less)
               b.   type
               c.   materials, including casing and filter material
               d.   location 


          5.   Tubing (If applicable)
          
               The following specifications for the tubing should be 
provided:  dimensions and materials for tubing and connectors.  Generally 
accepted materials for the tubing include silicone or PVC (most common).  



  Note: If the insufflator is intended for both hysteroscopic and 
laparoscopic insufflation ( or hysteroscopic insufflation and 
laparoscopic irrigation), you should provide the following information:

       A detailed discussion of the redundant fail-safe mechanisms that 
your device employs to insure that the device is not inadvertently used 
for the incorrect procedure.  Inadequate fail-safe mechanisms will result 
in product clearance delays.
       

  B.   Full Listing of Performance Specifications

       1.   Indicate the maximum and default values for each of the 
following parameters.  

                                Default   Maximum* 

            Pressure (mmHg)                                             

            Flow rate (cc/min)                                          


            FDA has currently cleared for marketing laparoscopic 
insufflators with maximum flow rates up to 20 l/min. The maximum 
sustained intra-abdominal pressure should not exceed 30 mmHg.  
Submissions for devices with maximum flow rates/pressures above these 
levels must include test data demonstrating that the higher flow 
rates/pressures do not adversely affect safety and effectiveness.   

       2.   Description of key safety features. Indicate which features 
are implemented by hardware and which are implemented by software.  Some 
recommended features are:

            a.   Overpressure protection 

                 (1)  Pressure overshoot not to exceed 45 mmHg for more 
than 15 seconds when establishing pneumoperitoneum.

                 (2)  Pressure relief at max pressure or when patient 
pressure exceeds set pressure by more than 5 mmHg for more than 5 sec.

                 (3)  Continuous, non-defeatable audible alarm and visual 
indicator at maximum pressure. 5 second delay allowed; temporary 
disabling not to exceed 30 seconds 

            
            b.   Supply tank

                 (1)  The supply tank connection should be pin-indexed to 
guard against inadvertent use of N2O, regardless of whether the device 
allows use of this media.

                 (2)  Front panel should display the amount of gas 
remaining in the supply tank, and a visual/audible alarm should warn the 
user when the level falls below some reasonable value.

            c.   Monitoring of the volume of gas delivered is desirable.

                 
  C.   System Level Hazard Analysis
  
       The system level hazard analysis should identify each potential 
patient hazard, the cause of the hazard, the level of concern, and the 
steps taken to address the potential hazard. Common hazards include: 
over-pressurization, gas intravasation, electric shock, and 
electromagnetic compatibility.

  D.   Software
       
       Insufflators that are software-controlled may be 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:

       1.   Structure chart or flow chart describing software 
architecture

       2.   Summary of software development procedures, including change 
procedures

       3.   Software Requirements Specification (ref IEEE/ANSI 830-1984), 
with traceability back to the Hazard Analysis                    

       4.   Verification and Validation Test plan, including  Pass/Fail 
criteria and traceability back to the requirements

       5.   System level test results 

       6.   Signed certification that "Software development was followed, 
that good quality assurance procedures were adhered to, and that test 
results demonstrate that the system specifications and the functional 
requirements were met".

       7.   Software version number and date

                           
  E.   Electrical safety
  
       The submitter should provide either:

            	    Certification that the device complies with 
applicable electrical safety standards (e.g., IEC 601-1, UL 544, UL 
2601); or 

            	    Test results which guarantee a similar level of 
protection.


  F.   Electromagnetic compatibility 

       The submitter should 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 which guarantee a similar level of 
protection; or

            	    Justification for why this information is unnecessary 
(e.g., due to device design or working conditions).


III.   Comparison Table

  Provide a table that lists the similarities and differences between 
your device and the predicate devices(s).  The table should include: 
intended use, design features, maximum flow rate, maximum output 
pressure, important safety features, and any other relevant device 
characteristics.

  
IV.    Labeling

  Indications for Use

  This device provides CO2 gas distension of the abdomen for diagnostic 
and/or operative laparoscopy.   See the operators manual of your 
laparoscope for specific indications for use.

  Contraindications for Use

       Use of this device for intraabdominal distension is 
contraindicated whenever laparoscopy is contraindicated.  See the 
operators manual of your laparoscope for absolute and relative 
contraindications.

       This device is contraindicated for hysteroscopic insufflation - it 
must not be used for intrauterine distension.

                 Note:  The distension pressure of a laparoscopic 
insufflator should not exceed 30 mmHg.
  
  

  Warnings

            Metabolic Acidosis and Resultant Cardiac Irregularity.  
Prolonged intra-abdominal pressures greater than 20 mmHg should be 
avoided.  This can cause any of the following:

                      Decreased respiration with compromised 
diaphragmatic excursion
                      Decreased venous return
                      Decreased cardiac output 
                      Acidosis                 

            Excessive absorption of CO2 results from either excessive 
flow and/or excessive pressure.   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.  Little intravasation should 
occur at these levels.  Pressures over 20 mmHg are virtually never needed 
and will increase the amount and rapidity of intravasation.   Adequate 
respirations help avoid problems related to CO2.  The insufflator should 
not permit an intra-abdominal pressure that exceeds 30 mmHg

            Operative procedures should only be performed with 
insufflators capable of flow rates of at least 4-10 l/min.  Insufflators 
with lower maximum flow rates should only be used for diagnostic 
procedures.

            Idiosyncratic reactions.  In patients with sickle cell 
disease or pulmonary insufficiency use of these devices may pose increase 
risks of metabolic imbalance related to excessive CO2 absorption.

            Hypothermia.  High-flow rate insufflators may present a 
potential risk for hypothermia.

       
  Precautions

            Use of a bacterial hydrophobic filter is strongly recommended 
to prevent patient cross-contamination.

  Instructions for Use

            Clinical Use
            Assembly, disassembly, evaluation, care & storage

            Cleaning and sterilization

                 Note:  Tubing sets and filters for laparoscopic surgery 
                 should either be provided sterile or include adequate 
                 instruction for sterilization.  If they are re-usable, 
                 instructions on how to re-sterilize them must be 
                 provided. Disinfection alone is not adequate.
       
                 If applicable, provide test data showing the effects of 
                 repeated sterilization on reusable filters.

Hysteroscopic Insufflators

I.     Intended Use

  Identify the intended use of the device, being as specific as possible.  
For example:

       This device is intended to distend the uterus by filling the 
uterine cavity with a liquid or gas to facilitate viewing with a 
hysteroscope (21 CFR   884.1700).
       


II.    Description of Insufflator

  A.   Physical and/or Electronic Description
       
       1.   Provide a diagram illustrating the flow of gas/liquid from 
its source to the exit port of the scope.  Include all safety features 
and any filters.

       2.   Indicate whether the device regulates and/or displays each of 
the following parameters:

                                Displays       Regulates

            Intrauterine Pressure                                                 

              
            Flow Rate                                                   

            Volume Delivered                                                 

            
            Net Volume                                          


       3.   Distension Media 
       
            a.   If the distension medium gas (CO2) or liquid?
            b.   What is the reservoir type?
            
       4.   Filter (If applicable)
       
            For gas hysteroscopic insufflators, use of a hydrophobic 
filter between the patient and the insufflator to prevent patient 
cross-contamination is highly recommended. The following specifications 
for the filter should be provided:  

            a.   pore size (0.2 micron or less)
            b.   type
            c.   materials, including casing and filter material
            d.   location

       5.   Tubing (If applicable)

            The following specifications for the tubing should be 
provided:  dimensions and materials for tubing and connectors.  Generally 
accepted materials for the tubing include silicone or PVC (most common).  




  Note: If the insufflator is intended for both hysteroscopic and 
laparoscopic insufflation ( or hysteroscopic insufflation and 
laparoscopic irrigation), you should provide the following information:

       A detailed discussion of the redundant fail-safe mechanisms that 
your device employs to insure that the device is not inadvertently used 
for the incorrect procedure.   Inadequate fail-safe mechanisms will 
result in product clearance delays.
       


  B.   Full Listing of Performance Specifications

       1.   Provide bench data illustrating the intrauterine pressure 
developed by your device at various output pressures and flow rates.  If 
your device is capable of applying suction, collect test data for both 
the "no-suction" and the "maximum suction" scenarios.  Your testing 
should include at least three different make/models of hysteroscopes.

       2.   Please describe how your device controls intrauterine 
pressure and/or flow rate. Sketches of flow rate and intrauterine 
pressure versus time for both the filling phase and the steady state 
phase are extremely helpful.  If your device measures volume or net 
volume delivered to patient, please describe how these measurements are 
made.

       3.   Indicate the maximum and default values for each of the 
following parameters.  

                                Default        Maximum 

            Intrauterine                                        *            

              Pressure (mmHg)

            Flow rate (cc/min)                                  **                

  
            Output pressure                                     
              (mmHg)


            *  For both liquid and gas insufflators, maximum sustained 
intrauterine pressure should not exceed 150 mmHg.   Since pressures 
greater than 100 mmHg are rarely needed, manufacturers are encouraged to 
develop insufflators that require positive action on the part of the user 
to increase pressure above 100 mmHg. 

            ** We have currently cleared for marketing liquid 
hysteroscopic insufflators with maximum flow rates up to 450 cc/min.  
Submissions with maximum liquid flow rates above these levels must 
include test data demonstrating that the higher flow rates do not 
adversely affect safety and effectiveness.  Maximum flow rates for gas 
hysteroscopic insufflators may not exceed 100 cc/min.


       4.   Description of key safety features. Indicate which features 
are implemented by hardware and which are implemented by software.  Some 
recommended features are:

            a.   Overpressure protection 

                 (1)  Pressure overshoot not to exceed 150 mmHg for more 
than 15 seconds during initial distension. 

                 (2)  Pressure relief at max pressure or when patient 
pressure exceeds set pressure by more than 5 mmHg for more than 5 sec.

                 (3)  Continuous, non-defeatable audible alarm and visual 
indicator at maximum pressure. 5 second delay allowed; temporary 
disabling not to exceed 30 seconds 

            b.   A venting mechanism to prevent over-pressurization is 
advantageous.

            c.   Supply tank (gas hysteroscopy)

                 (1)  The supply tank connection should be pin-indexed to 
guard against inadvertent use of N2O, regardless of whether the device
allows use of this media.

                 (2)  Front panel should display the amount of gas 
remaining in the supply tank, and a visual/audible alarm should warn the 
user when the level falls below some reasonable value.

            d.   Monitoring of the volume of gas/fluid delivered is 
desirable.
            

  C.   System Level Hazard Analysis

       The system level hazard analysis should identify each potential 
patient hazard, the cause of the hazard, the level of concern, and the 
steps taken to address the potential hazard. Common hazards include: 
over-pressurization, intravasation, electric shock, and electromagnetic 
compatibility.

  D.   Software
       
       Insufflators that are software-controlled may be 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:

       1.   Structure chart or flow chart describing software 
architecture

       2.   Summary of software development procedures, including change 
procedures

       3.   Software Requirements Specification (ref IEEE/ANSI 830-1984), 
with traceability back to the Hazard Analysis                    

       4.   Verification and Validation Test plan, including  Pass/Fail 
criteria and traceability back to the requirements

       5.   System level test results 

       6.   Signed certification that "Software development was followed, 
that good quality assurance procedures were adhered to, and that test 
results demonstrate that the system specifications and the functional 
requirements were met".

       7.   Software version number and date

  E.   Electrical safety

       The submitter should provide either:

            	    Certification that the device complies with 
applicable electrical safety standards (e.g., IEC 601-1, UL 544, UL 
2601); or 

            	    Test results which guarantee a similar level of 
protection.


  F.   Electromagnetic compatibility. 

       The submitter should 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 which guarantee a similar level of 
protection; or

            	    Justification for why this information is unnecessary 
(e.g., due to device design or working conditions).



III.   Comparison Table

  Provide a table that lists the similarities and differences between 
your device and the predicate devices(s).  The table should include: 
intended use, design features, maximum flow rate, maximum intrauterine 
pressure, important safety features, and any other relevant device 
characteristics.



IV.    Labeling

  A.   Gas Hysteroscopic Insufflation

       Indications for Use

            This device provides CO2 gas distension of the uterus for 
diagnostic and operative hysteroscopy.  See the operators manual of your 
hysteroscope for specific indications for use.


       Contraindications for use
       
            Use of this device for intrauterine distension is 
contraindicated whenever hysteroscopy is contraindicated.  See the 
operators manual of your hysteroscope for absolute and relative 
contraindications.
  
            Operative hysteroscopy.  Gas emboli and cardiac arrest have 
been reported during hysteroscopic laser and electrosurgical procedures.  
Because of the increased risk of gas embolization during operative 
hysteroscopy, this device should not be used for such procedures.


       Warnings

       This device is ineffective for laparoscopic insufflation -  it 
should not be used for intra-abdominal distension.

       Metabolic Acidosis and Resultant Cardiac Irregularity.  

            Excessive absorption of CO2 results from either excessive 
flow and/or excessive pressure.  The uterine cavity can be adequately 
distended by pressure in the range of 35-75 mmHg.  It is seldom necessary 
to use an intrauterine pressure greater than 75 mmHg or a flow rate 
greater than 100 cc/min.  Little intravasation or tubal passage should 
occur at these levels.  Pressures over 100 mmHg are virtually never 
needed and will increase the amount and rapidity of intravasation and 
tubal passage of gas.  Adequate respirations help avoid problems related 
to CO2.

       Idiosyncratic reactions.  

            In patients with sickle cell disease or pulmonary 
insufficiency use of these devices may pose increase risks of metabolic 
imbalance related to excessive CO2 absorption.

       CO2 Embolization.  

            Risk of CO2 embolism increases with CO2 flow rate. As such, 
insufflators should not be used above 100 ml/minute.

                 Note:  Your insufflator should be calibrated not to 
exceed 100 ml/minute.

       Rupture of a Fallopian Tube Secondary to Tubal Obstruction. This 
is generally due to increased pressure above 150 mmHg.  
       
                 Note:  Your insufflator should not exceed this level.

       Instructions for Use

            Clinical Use
            Assembly, disassembly, care & storage
            Cleaning and sterilization

                 Note: Tubing sets and filters for hysteroscopic surgery 
must be provided sterile, and if they are re-usable, instructions on how 
to re-sterilize them must be provided.  Disinfection alone is not 
adequate.
       
                 If applicable, provide test data showing the effects of 
repeated sterilization on reusable filters.


  B.   Liquid Hysteroscopic Insufflation

       Indications for Use

            This device provides liquid distension of the uterus for 
diagnostic and operative hysteroscopy.  See the operators manual of your 
hysteroscope for specific indications for use.

       Contraindications for use

            Use of this device for intrauterine distension is 
contraindicated whenever hysteroscopy is contraindicated.  See the 
operators manual of your hysteroscope for absolute and relative 
contraindications.

       
       Warnings

            If a liquid distension medium is used, strict fluid intake 
and output surveillance should be maintained.  If a low viscosity liquid 
distension medium is used, intrauterine instillation exceeding 2 liters 
should be followed with great care due to the possibility of fluid 
overload.  

            (If applicable) If a high viscosity fluid (e.g., Hyskon) is 
used, the use of more than 500 ml should be followed with great care.  
See labeling for Hyskon for additional information.

            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. 

            Complications may include:

                 Hyponatremia.  Intravasation of some distension fluids 
may lead to fluid overload and, consequently, hyponatremia with its 
attending sequelae. This can be affected by the distending pressure, flow 
rate, and duration of hysteroscopic procedure.  It is critical to closely 
monitor the input and outflow of the distending liquid.  

                 Hypothermia

                 Pulmonary Edema

                 Idiosyncratic Reaction.  (Intravascular coagulopathy; 
allergic reaction, including anaphylaxis)

                 Rupture of a Fallopian Tube Secondary to Tubal 
Obstruction. Cerebral Edema


       Instructions for Use
       
            Choice of distension media:

                 1.   Conductive vs. Non-Conductive Media

                           When performing hysteroscopic electrosurgery, 
the distension medium must be electrically non-conductive. Examples 
include D5W, glycine, sorbitol, mannitol, sorbitol plus mannitol, and 
dextran.

                 2.   Low Viscosity vs. High Viscosity Media

                 Assembly, disassembly, care & storage
                 Cleaning and Sterilization

                             References


  Association for the Advancement of Medical Instrumentation. American 
National Standard for Electrosurgical Devices [Standard]. ANSI/AAMI 
HF18-1986. September 1986.

  Institute of Electrical and Electronics Engineers. IEEE Guide to 
Software Requirements Specifications, ANSI/IEEE 830-1984.

  International Electrotechnical Commission. Medical Electrical 
Equipment, Part 1: General Requirements for Safety [Standard]. IEC 
Publication 601-1, 1988.

  International Electrotechnical Commission. Medical Electrical 
Equipment, Part 1-2: Collateral Standard: Electromagnetic compatibility - 
Requirements and Tests [Standard]. IEC Publication 601-1, 1993-04.

  ECRI. "Laparoscopic Insufflators." Health Devices 1992:21:143-82.

  Corfman, R.S.; Diamond, M.P., and DeCherney, A.H., Eds Complications of 
Laparoscopy and Hysteroscopy, Boston: Blackwell Scientific Publications, 
1993.

  "ACOG Technical Bulletin Number 1991 - Hysteroscopy", International 
Journal of Gynecology
  and Obstetrics, 45:175-80, 1994.