Post

Preparation of 510k Submissions for General Surgical Meshes

This guidance provides specific information for preparing a premarket notification (510(k)) submission for general surgical meshes under 21 CFR 878.3300. It covers Surgical Mesh (79 FTM) and Polymeric Surgical Mesh (79 FTL) for general surgical uses such as hernia repair, suture line reinforcement, muscle flap reinforcement, and gastric banding. It excludes meshes for orthopedic or dental uses.

  1. Develop comprehensive physical and material characterization testing plan
  2. Establish biocompatibility testing program based on device classification
  3. Implement sterilization validation program with appropriate SAL
  4. For animal-derived materials, establish viral inactivation validation protocol
  5. Create stability testing program for shelf-life determination
  6. Prepare detailed device description including all material components
  7. Develop labeling that complies with requirements and restrictions
  8. Document manufacturing process including all reagents and processing steps
  9. Create specifications for in-process and final product testing
  10. For biodegradable devices, establish protocols for degradation testing

Key Considerations

Non-clinical testing

  • Product characterization testing required:
    • Mesh thickness
    • Mesh weave characteristics
    • Pore size
    • Mesh density
    • Tensile strength
    • Device stiffness
    • Suture pullout strength
    • Burst strength
    • Tear resistance

Biocompatibility

  • Required testing for all devices:
    • Cytotoxicity
    • Sensitization
    • Irritation/Intracutaneous reactivity
    • Systemic toxicity (acute)
    • Genotoxicity
    • Implantation with histology
    • Hemolysis
    • Pyrogenicity
  • Additional testing for devices remaining >30 days:
    • Subchronic toxicity
    • Chronic toxicity
  • Long-term carcinogenicity studies if positive genotoxicity results

Labelling

  • Must specify intended use, contraindications, warnings, precautions, directions for use
  • Cannot claim reduction of post-surgical adhesions
  • If labeled “pyrogen free,” must provide USP Pyrogen Test results

Safety

  • Sterility Assurance Level (SAL) of 10^-6 required
  • For animal-derived materials:
    • Viral inactivation validation required
    • Must demonstrate reduction below 1 infectious particle per 10^6 devices
  • For EtO sterilization, must meet residual limits for implant size categories

Other considerations

  • ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
  • ICH: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Original guidance

  • Preparation of 510k Submissions for General Surgical Meshes
  • HTML / PDF
  • Issue date: 1999-03-01
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 18404afc88eab0f2427cf1793815e297
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