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Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation

This guidance is focused on Class II electrosurgical devices and accessories classified under 878.4400 intended for general tissue cutting and/or coagulation. The guidance applies to devices that may have multiple uses including open and minimally invasive procedures, as well as arthroscopic indications. It excludes dental, endoscopic, radiofrequency lesion, and thermal cautery devices classified under other regulations.

  1. Determine device classification and applicable requirements
  2. Develop comprehensive test plan covering all components and system
  3. Conduct biocompatibility assessment and testing
  4. Perform electrical safety and EMC testing
  5. Validate software and cybersecurity features
  6. Develop complete labeling package with all required elements
  7. Validate sterilization process if applicable
  8. Conduct shelf life testing
  9. Prepare performance data package demonstrating substantial equivalence
  10. Consider early FDA engagement through Q-submission if novel features present
  11. Validate reprocessing instructions for reusable devices
  12. Document compatibility with other system components

Key Considerations

Clinical testing

  • Generally not necessary for general surgery indications
  • May be required if device indications/technology significantly different from predicate
  • Clinical data often needed for aesthetic use devices

Non-clinical testing

  • Performance testing required for individual components and complete system
  • Thermal effects testing on tissue required (ex vivo testing acceptable)
  • Temperature monitoring validation if feature included
  • Contact quality and continuity monitoring validation if included
  • Capacitive coupling testing for minimally invasive devices

Software

  • Enhanced Documentation Level generally required
  • Full software documentation following FDA software guidance
  • Cybersecurity documentation required for networked devices
  • Additional documentation needed for off-the-shelf software

Cybersecurity

  • Must address confidentiality, integrity, availability and accountability
  • Required for devices with communication features
  • Special considerations for networked devices and wireless technology

Labelling

  • Detailed instructions for use required
  • Specific warnings and cautions needed
  • Operating information and compatibility guidance
  • Component-specific labeling requirements
  • Reprocessing instructions for reusable devices

Biocompatibility

  • Testing required for all patient-contacting materials
  • Cytotoxicity, sensitization, irritation testing needed
  • Additional testing based on contact duration and type
  • Material-mediated pyrogen testing if labeled non-pyrogenic

Safety

  • Electrical safety testing per IEC 60601 standards
  • EMC testing required
  • Basic safety and performance requirements
  • Special requirements for endoscopic/laparoscopic instruments

Other considerations

  • 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: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances
  • IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for high frequency surgical equipment
  • IEC 60601-2-18: Medical electrical equipment – Part 2-18: Particular requirements for endoscopic equipment
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Original guidance

  • Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
  • HTML / PDF
  • Issue date: 2020-03-09
  • Last changed date: 2020-03-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), General & Plastic Surgery, 510(k), Premarket, Labeling, Clinical - Medical
  • ReguVirta summary file ID: d9add73b94ea6f7b966995deb63bcc11
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