Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements

What You Need to Know? 👇

What are the key performance tests required for bipolar electrosurgical vessel sealers in 510(k) submissions?

The FDA requires burst pressure testing to evaluate seal strength, thermal spread testing to assess tissue damage, mechanical testing of active electrodes, system testing with all components, and chronic animal studies (minimum 3 weeks, 5 animals) to demonstrate long-term seal quality and safety.

Do bipolar vessel sealers for general surgery typically require clinical data for FDA clearance?

Clinical data are generally not necessary for 510(k) submissions of bipolar electrosurgical vessel sealers intended for general surgery. However, clinical testing may be required if device indications or technology differ significantly from predicate devices and nonclinical testing is insufficient.

What specific labeling warnings must be included for bipolar vessel sealer submissions?

Key warnings include contraindication for tubal sterilization, maximum vessel diameter limitations, prohibition of use with flammable anesthetics, proper vessel placement in jaw center, inspection requirements before cutting, and warnings about electronic implants like pacemakers requiring professional consultation.

Can a single 510(k) submission cover multiple components of a vessel sealing system?

Yes, a 510(k) can include multiple components (ESU, active accessories, miscellaneous accessories) if they’re part of the same submission. Each component must be clearly described with model numbers, and previously cleared components can reference their 510(k) numbers instead of repeating testing.

What animal study requirements apply to vessel sealer chronic testing?

Chronic animal studies must follow Good Laboratory Practices (GLP), use minimum 5 animals for 3+ weeks, seal multiple vessels per animal, include both arteries and veins, document surgical procedures, and provide histopathology reports showing vessel healing and absence of leakage or adjacent tissue damage.

How should substantial equivalence be demonstrated for vessel sealers with multiple predicate devices?

When using multiple predicates, provide justification for each predicate’s use, address why combining features doesn’t raise different safety/effectiveness questions, and demonstrate that technologies can function independently without interference. Performance data may be needed to support the combination approach and substantial equivalence claims.

---

What You Need to Do 👇

Recommended Actions

1. Conduct comprehensive non-clinical testing including burst pressure and thermal spread studies
2. Perform chronic animal studies for new systems or significant modifications
3. Develop detailed labeling including all required warnings and instructions
4. Validate compatibility between all system components
5. Ensure compliance with relevant electrical safety standards
6. Document maximum vessel size and validate through testing
7. Provide clear reprocessing instructions for reusable components
8. Consider pre-submission consultation if clinical data may be needed
9. Develop comprehensive risk management documentation
10. 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
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
• 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 ID: 16bf170b5e807edb29521be454ce9aba