Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
This guidance addresses Class II bipolar electrosurgical vessel sealers intended for use in general surgery to seal isolated blood and lymphatic vessels for hemostasis. It specifically covers devices classified under 21 CFR 878.4400 (Electrosurgical cutting and coagulation device and accessories). The guidance excludes devices that don't deliver radiofrequency electrical current, monopolar devices, devices not indicated for vessel sealing, and devices intended for specific surgical procedures outside general surgery.
Recommended Actions
- Conduct comprehensive non-clinical testing including burst pressure and thermal spread studies
- Perform chronic animal studies for new systems or significant modifications
- Develop detailed labeling including all required warnings and instructions
- Validate compatibility between all system components
- Ensure compliance with relevant electrical safety standards
- Document maximum vessel size and validate through testing
- Provide clear reprocessing instructions for reusable components
- Consider pre-submission consultation if clinical data may be needed
- Develop comprehensive risk management documentation
- Prepare detailed test reports with pre-defined acceptance criteria
Key Considerations
Clinical testing
- Generally not necessary for 510(k) submissions unless device indications or technology are significantly different from predicate devices
- Pre-submission consultation recommended if clinical data deemed necessary
Non-clinical testing
- Burst pressure testing comparing seal strength to predicate device
- Thermal spread testing to evaluate damage zone
- Chronic animal study (minimum 3 weeks, 5 animals) for new systems or significant modifications
- System performance testing when components are used together
- Mechanical testing for active components (drop tests, bending force, etc.)
- Output waveform and power output testing for ESU
Labeling
- Clear indications for use statement
- Specific contraindications for tubal sterilization
- Detailed warnings about electronic implants, vessel size limits, flammable materials
- Operating instructions and specifications
- Component compatibility information
- Cleaning/sterilization instructions for reusable instruments
Safety
- Electrical safety testing per 60601 standards
- Insulation integrity testing for reusable instruments
- Protection against inadvertent activation
- Smoke evacuation considerations
Other considerations
- Maximum vessel size must be clearly stated
- Compatibility between components must be demonstrated
- Reprocessing validation for reusable instruments
Relevant Guidances
- Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- AAMI/ANSI ES 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: Electromagnetic compatibility
- IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment
- IEC 60601-2-18: Medical electrical equipment - Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment
Original guidance
- Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- HTML / PDF
- Issue date: 2016-08-15
- Last changed date: 2020-03-02
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), General & Plastic Surgery, 510(k), Premarket, Labeling, Clinical - Medical
- ReguVirta summary file ID: 16bf170b5e807edb29521be454ce9aba
This post is licensed under CC BY 4.0 by the author.