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Dura Substitute Devices - Premarket Notification (510k) Submissions

This guidance provides recommendations for manufacturers submitting premarket notification (510(k)) for dura substitute devices, which are class II devices used to repair the dura mater (membrane surrounding the brain). It covers devices made from both synthetic and natural materials.

  1. Develop comprehensive testing plan covering physical, mechanical, and biocompatibility requirements
  2. Design and execute animal studies at intended anatomic site
  3. Plan multicenter clinical trial if using novel materials
  4. Establish detailed manufacturing controls and specifications
  5. Validate sterilization process and stability
  6. Prepare comprehensive labeling including detailed surgical instructions
  7. For animal-derived materials, establish robust sourcing controls and documentation
  8. Develop product characterization protocols
  9. Create detailed documentation of all testing and validation activities
  10. Establish post-market surveillance plan for safety monitoring

Key Considerations

Clinical testing

  • Multicenter clinical trials required for materials not previously used in neurological applications
  • One-year follow-up typically required
  • Study should evaluate:
    • CSF leakage
    • Complications (intraoperative and postoperative)
    • Device effectiveness compared to predicate devices
    • Patient populations and inclusion/exclusion criteria clearly defined

Non-clinical testing

  • Physical and mechanical properties testing required:
    • Device thickness
    • Tensile strength
    • Suture retention strength
    • Burst strength
    • Shrink temperature range
    • Surface structure

Human Factors

  • Questionnaire recommended for investigators regarding ease of handling and device conformability

Biocompatibility

  • Testing required per ISO 10993-1:
    • Cytotoxicity
    • Sensitization
    • Irritation
    • Acute systemic toxicity
    • Mutagenicity
    • Hemolysis
  • Additional for >30 days implants:
    • 90-day subchronic toxicity
    • 180-day chronic toxicity

Labeling

  • Must include:
    • Specific indications for use
    • Target populations
    • Comprehensive instructions for:
      • Pre-implant training
      • Patient preparation
      • Implantation procedures
      • Follow-up care

Safety

  • Sterilization validation required with SAL of 10-6
  • Pyrogenicity testing (<0.06 EU/ml)
  • Stability testing for expiration dating
  • Animal studies at intended anatomic site required

Other considerations

  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing
  • ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • AAMI TIR-19: Guidance for ANSI/AAMI/ISO 10993-7

Original guidance

  • Dura Substitute Devices - Premarket Notification (510k) Submissions
  • HTML / PDF
  • Issue date: 2000-11-08
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 673d5ad11f7acd1a93f901c1cb6aed38
This post is licensed under CC BY 4.0 by the author.