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.
What You Need to Know? 👇
What are the key biocompatibility requirements for thermal endometrial ablation devices?
Patient-contacting materials must undergo biocompatibility testing on the finished device under actual use conditions (e.g., heated to operating temperature). Testing should follow Good Laboratory Practices per 21 CFR 58, or provide certification that identical materials are used in legally marketed devices.
What clinical studies are required before submitting a PMA for thermal endometrial ablation devices?
Three sequential studies are required: a feasibility safety study (5-10 pre-hysterectomy patients), a feasibility effectiveness study (minimum 20 patients), and a randomized controlled safety/effectiveness study comparing to legally marketed endometrial ablation devices with 12-month follow-up.
What software documentation is needed for thermal endometrial ablation devices with automated controls?
Documentation must include software development lifecycle, risk management activities, system requirements, verification/validation activities, traceability between hazards and safety functions, test results, current version number, and remaining bugs. Follow “Reviewer Guidance for Computer Controlled Medical Devices” standards.
What sterilization requirements apply to thermal endometrial ablation devices?
Devices contacting sterile tissue require sterilization. For reusable components, provide detailed reprocessing instructions and validation certification. For single-use components, specify sterilization method, sterility assurance level, validation method, packaging system, and residue levels for ethylene oxide or radiation dose.
What electrical safety and EMC standards must thermal endometrial ablation devices meet?
Devices must comply with applicable electrical safety standards (IEC 601-1, UL 544, UL 2601) and electromagnetic compatibility standards (IEC 601-1-2, IEC 801-2,3,4,5, CISPR 11), or provide test results demonstrating equivalent protection levels.
What are the patient inclusion criteria for thermal endometrial ablation clinical studies?
Patients must have uterine bleeding from benign conditions meeting excessive bleeding criteria, failed previous medical therapy with oral contraceptives or cyclic progestins, uterine sound measurements ≤12 cm, and be unsuitable candidates for hysterectomy with no desire for future fertility.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive in vitro and animal testing before human studies
- Develop detailed clinical investigation plan following three-phase approach
- Validate sterilization procedures and reprocessing instructions
- Complete software documentation and validation
- Prepare comprehensive labeling including all required elements
- Conduct biocompatibility testing on final device
- Obtain electrical safety and EMC certifications
- Develop manufacturing process documentation
- Prepare environmental impact assessment
- 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
- Manufacturing process description
- Sterilization validation
- Environmental impact assessment
- Device commercialization plans
Relevant Guidances đź”—
- Design Controls for Medical Device Manufacturers
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Benefit-Risk Determinations for Medical Device Premarket Review
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms đź“‚
- 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 ID: bfbe8781dc70b6de1364fba4e6f8c21e