Premarket Notification Requirements for Hysteroscopic and Laparoscopic Insufflators
This guidance outlines the information required for 510(k) premarket notification submissions for hysteroscopic and laparoscopic insufflators. It covers both gas and liquid insufflation devices used to distend the uterus for hysteroscopy or the peritoneal cavity for laparoscopy.
What You Need to Know? 👇
What are the maximum pressure limits for laparoscopic and hysteroscopic insufflators?
For laparoscopic insufflators, maximum sustained intra-abdominal pressure should not exceed 30 mmHg. For hysteroscopic insufflators, maximum sustained intrauterine pressure should not exceed 150 mmHg, though pressures greater than 100 mmHg are rarely needed.
What software documentation is required for computer-controlled insufflators in 510(k) submissions?
Required documentation includes software architecture charts, development procedures, requirements specification with hazard analysis traceability, verification/validation test plans, system test results, signed certification of compliance, and software version number with date.
Are bacterial filters mandatory for insufflator systems?
While not mandatory, hydrophobic bacterial filters (0.2 micron or less) are highly recommended between patient and insufflator to prevent cross-contamination. For hysteroscopic surgery, tubing sets and filters must be provided sterile.
What electrical safety standards must insufflators comply with for FDA clearance?
Insufflators must comply with applicable electrical safety standards such as IEC 601-1, UL 544, or UL 2601. Alternatively, manufacturers can provide test results demonstrating equivalent protection levels.
What fail-safe mechanisms are required for dual-purpose insufflators?
Devices intended for both hysteroscopic and laparoscopic procedures must include detailed redundant fail-safe mechanisms to prevent inadvertent use for incorrect procedures. Inadequate fail-safe mechanisms will result in product clearance delays.
What are the contraindications for gas insufflation during operative hysteroscopy?
Gas insufflators should not be used for operative hysteroscopy due to increased risk of gas embolization. Gas emboli and cardiac arrest have been reported during hysteroscopic laser and electrosurgical procedures.
What You Need to Do 👇
Recommended Actions
- Prepare detailed device description including physical/electronic characteristics and performance specifications
- Conduct and document system level hazard analysis
- Perform required bench testing for pressure and flow rates
- Complete software documentation package if device is software-controlled
- Obtain electrical safety and EMC certifications
- Develop comprehensive labeling including all required warnings and instructions
- Create comparison table with predicate devices
- Ensure device meets maximum pressure and flow rate limits (30 mmHg for laparoscopic, 150 mmHg for hysteroscopic)
- Implement recommended safety features including overpressure protection
- Prepare filter and tubing specifications if applicable
Key Considerations
Non-clinical testing
- Bench testing data showing intrauterine pressure at various output pressures and flow rates
- System level test results for software validation
- Electrical safety testing
- Electromagnetic compatibility testing
Software
- Structure chart/flow chart describing software architecture
- Software development procedures documentation
- Software Requirements Specification with hazard analysis traceability
- Verification and Validation Test plan with pass/fail criteria
- System level test results
- Signed certification of software development process
- Software version number and date
Labelling
- Intended use
- Contraindications
- Warnings about pressure limits and complications
- Instructions for use including assembly, cleaning and sterilization
- Specific warnings for gas vs liquid insufflation
- Information about distension media compatibility
Safety
- System level hazard analysis identifying potential patient hazards
- Overpressure protection mechanisms
- Maximum pressure and flow rate limits
- Safety features for supply tanks
- Volume monitoring capabilities
Other considerations
- Physical and electronic device description
- Performance specifications
- Comparison table with predicate devices
- Filter specifications if applicable
- Tubing specifications if applicable
Relevant Guidances 🔗
- Content of Premarket Submissions for Device Software Functions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms 📂
- IEC 601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
- IEC 601-1-2: Medical Electrical Equipment, Part 1-2: Electromagnetic compatibility
- IEEE/ANSI 830-1984: Guide to Software Requirements Specifications
- UL 544: Medical and Dental Equipment
- UL 2601: Medical Electrical Equipment
- CISPR 11: Industrial, Scientific and Medical Equipment - Radio-frequency disturbance characteristics
Original guidance
- Premarket Notification Requirements for Hysteroscopic and Laparoscopic Insufflators
- HTML
- Issue date: 1995-07-31
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta ID: 2965dac02ffadf6e9229180a1b1f335d