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.
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