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.
Recommended Actions
- Determine if your device falls within scope of guidance
- Conduct required physical testing (diameter, tensile strength, needle attachment)
- Perform resorption profile testing if applicable
- Complete biocompatibility evaluation based on contact duration/type
- Validate sterilization process and packaging
- Conduct shelf life studies
- Prepare labeling with required information
- Document all test results and prepare summaries
- Consider Pre-Submission if additional testing may be needed
- 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
- Color additives must meet 21 CFR 70.5(c) requirements
- Manufacturing process must be identical to predicate device if claiming biocompatibility equivalence
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
Related references and norms
- 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
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