Post

IDE Requirements for Thermal Endometrial Ablation Devices

This guidance outlines the requirements for submitting an Investigational Device Exemption (IDE) application for Thermal Endometrial Ablation Devices. These devices are intended to ablate the endometrium using various heating methods (conductive heating, RF energy, microwave energy, cryosurgery) where the user has no direct control over the procedure once initiated.

  1. Conduct comprehensive in vitro and animal testing before human studies
  2. Develop detailed clinical investigation plan following three-phase approach
  3. Validate sterilization procedures and reprocessing instructions
  4. Complete software documentation and validation
  5. Prepare comprehensive labeling including all required elements
  6. Conduct biocompatibility testing on final device
  7. Obtain electrical safety and EMC certifications
  8. Develop manufacturing process documentation
  9. Prepare environmental impact assessment
  10. Plan for long-term follow-up studies (3 years total)

Key Considerations

Clinical testing

  • Three-phase clinical study approach required:
    • Feasibility Safety Study (5-10 pre-hysterectomy patients)
    • Feasibility Effectiveness Study (minimum 20 patients)
    • Safety and Effectiveness Study (randomized controlled trial)
  • 12 months follow-up data required for PMA approval
  • Post-market follow-up for 3 years total

Non-clinical testing

  • In vitro and animal testing required before human studies
  • System-level testing demonstrating device performance
  • Temperature measurements and histological examination during safety studies

Software

  • Documentation of software development lifecycle
  • System and software requirements
  • Structure charts
  • Verification and validation activities
  • Test results
  • Current version number and bug list

Labelling

  • Name and place of business
  • Quantity of contents
  • Directions for use
  • Reprocessing instructions
  • Contraindications, hazards, warnings
  • “CAUTION - Investigational Device” statement

Biocompatibility

  • Testing on finished device or certification of identical materials
  • Samples prepared reflecting actual conditions of use
  • Conformance with GLP requirements

Safety

  • Electrical safety certification (IEC 601-1, UL 544, UL 2601)
  • EMC compliance (IEC 601-1-2, IEC 801-2,3,4,5, CISPR 11)
  • System-level hazard analysis

Other considerations

  • IEC 601-1: Medical electrical equipment - Part 1: General requirements for safety
  • IEC 601-1-2: Medical electrical equipment - Part 1-2: EMC requirements and tests
  • ISO 10993: Biological evaluation of medical devices
  • UL 544: Medical and Dental Equipment
  • UL 2601: Medical Electrical Equipment

Original guidance

  • IDE Requirements for Thermal Endometrial Ablation Devices
  • HTML
  • Issue date: 1996-03-13
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: bfbe8781dc70b6de1364fba4e6f8c21e
This post is licensed under CC BY 4.0 by the author.