GUIDANCE DOCUMENT
Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) August 1995
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.