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Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions

This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices used to remove atherosclerotic plaque from diseased arteries. It covers devices regulated under 21 CFR 870.4875 with product code MCW (Intraluminal Artery Stripper). The guidance excludes atherectomy devices used in coronary vasculature which require PMA approval.

  1. Conduct comprehensive risk analysis following ISO 14971
  2. Develop test plan covering all required testing categories:
    • Engineering bench testing
    • Biocompatibility
    • Sterilization validation
    • Animal studies if needed
    • Clinical studies if needed
  3. Prepare documentation for software and cybersecurity if applicable
  4. Validate device performance through simulated use testing
  5. Conduct particulate and coating evaluations if applicable
  6. Prepare comprehensive labeling with all required information
  7. Consider early engagement with FDA through Q-Submission program
  8. Validate shelf life and packaging
  9. Prepare complete test reports following FDA guidance format
  10. Consider need for clinical data based on device novelty and indications

Key Considerations

Clinical testing

  • Multi-center prospective study recommended for new devices and modifications
  • Sample size based on sound clinical and statistical principles
  • Safety assessment through Major Adverse Events (MAEs) at 30 days
  • Performance assessment through acute technical success and clinical success at 6 months
  • Real-world data may be acceptable for expanded indications

Non-clinical testing

  • Simulated use testing in anatomical models
  • Engineering testing for dimensional verification, kink resistance, corrosion resistance, heat generation
  • Torsional and tensile strength testing
  • Rotational speed verification
  • Plaque removal efficiency testing
  • Life cycle/fatigue testing
  • Additional testing for in-stent restenosis applications

Software

  • Documentation level should be Basic for most peripheral atherectomy devices
  • Higher documentation level may be needed for novel applications
  • Software verification and validation required
  • Off-the-shelf software requires additional documentation

Cybersecurity

  • Cybersecurity documentation required if device includes software
  • Follow FDA guidance on cybersecurity for medical devices

Labelling

  • Must include adequate information for practitioner use
  • Include device specifications and performance characteristics
  • Describe operational parameters like rotational speed
  • Include orbit performance data if applicable
  • Specify duration of treatment and aspiration characteristics

Biocompatibility

  • Testing required for all patient-contacting materials
  • Cytotoxicity, sensitization, irritation testing needed
  • Acute systemic toxicity testing required
  • Hemocompatibility testing required
  • Additional testing may be needed for novel materials

Safety

  • Sterility validation required
  • Pyrogenicity testing needed
  • Shelf life validation required
  • Electrical safety testing per standards
  • Battery safety testing if applicable

Other considerations

  • ANSI/AAMI/ES 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices
  • ISO 10993-1: Biological evaluation of medical devices
  • ISO 14971: Medical devices - Application of risk management to medical devices
  • ASTM F1980: Standard guide for accelerated aging of sterile barrier systems for medical devices

Original guidance

  • Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 2021-05-20
  • Last changed date: 2021-05-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Cardiovascular, 510(k), Labeling, Premarket
  • ReguVirta summary file ID: 0fc9f342cf3ac230124c708d16d365dd
This post is licensed under CC BY 4.0 by the author.