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Testing and Performance Requirements for Surgical Sutures

This guidance covers absorbable and nonabsorbable surgical sutures intended for general soft tissue approximation and/or ligation in various procedures (ophthalmic, cardiovascular, neurological, orthopedic, dental). It excludes specific sutures like those for aesthetic uses, specialized cardiovascular applications, or those containing drugs/biologics, animal-derived materials, or novel features like barbs or anchors.

  1. Determine if your device falls within scope of guidance
  2. Conduct required physical testing (diameter, tensile strength, needle attachment)
  3. Perform resorption profile testing if applicable
  4. Complete biocompatibility evaluation based on contact duration/type
  5. Validate sterilization process and packaging
  6. Conduct shelf life studies
  7. Prepare labeling with required information
  8. Document all test results and prepare summaries
  9. Consider Pre-Submission if additional testing may be needed
  10. Submit 510(k) with all required performance data and declarations of conformity

Key Considerations

Non-clinical testing

  • Diameter testing according to USP requirements for both absorbable and nonabsorbable sutures
  • Needle attachment testing
  • Tensile strength testing
  • Resorption profile testing (for absorbable sutures)
  • Shelf life testing on aged devices
  • Package integrity testing

Labelling

  • Must clearly state if suture is non-USP compliant
  • Must identify maximum oversize in diameter for each suture size if applicable

Biocompatibility

  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute systemic toxicity
  • Material-Mediated Pyrogenicity
  • Subacute/Subchronic Toxicity
  • Genotoxicity
  • Implantation
  • Chronic Toxicity
  • Carcinogenicity
  • Hemocompatibility (for blood-contacting sutures)

Safety

  • Sterilization validation to SAL 10-6
  • Sterile barrier system validation
  • Package integrity testing

Other considerations

  • ISO 17665-1: Sterilization of health care products – Moist heat
  • ISO 11135-1: Sterilization of health care products – Ethylene oxide
  • ISO 11137-1: Sterilization of health care products — Radiation
  • ISO 20857: Sterilization of health care products — Dry heat
  • ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
  • ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems
  • ISO 10993-1: Biological evaluation of medical devices

Original guidance

  • Testing and Performance Requirements for Surgical Sutures
  • HTML / PDF
  • Issue date: 2022-04-11
  • Last changed date: 2022-04-08
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 5d0a7066b8085566af1cb13b2f8c70be
This post is licensed under CC BY 4.0 by the author.