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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.

  1. Prepare detailed device description including physical/electronic characteristics and performance specifications
  2. Conduct and document system level hazard analysis
  3. Perform required bench testing for pressure and flow rates
  4. Complete software documentation package if device is software-controlled
  5. Obtain electrical safety and EMC certifications
  6. Develop comprehensive labeling including all required warnings and instructions
  7. Create comparison table with predicate devices
  8. Ensure device meets maximum pressure and flow rate limits (30 mmHg for laparoscopic, 150 mmHg for hysteroscopic)
  9. Implement recommended safety features including overpressure protection
  10. 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

  • 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 summary file ID: 2965dac02ffadf6e9229180a1b1f335d
This post is licensed under CC BY 4.0 by the author.