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.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for surgical sutures?
The Safety and Performance Based Pathway is an optional FDA framework allowing manufacturers to demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than directly comparing their device to a predicate device, providing a less burdensome regulatory approach.
Which surgical sutures are covered under this FDA guidance?
The guidance covers Class II absorbable and nonabsorbable sutures including polydioxanone, poly(glycolide/L-lactide), polyethylene terephthalate, polypropylene, polyamide, silk, stainless steel, and expanded PTFE sutures intended for general soft tissue approximation and/or ligation.
What are the key performance criteria for surgical sutures under this pathway?
Key criteria include diameter specifications per USP standards, needle attachment strength, tensile strength requirements, resorption profile for absorbable sutures, sterilization validation, shelf life testing, and comprehensive biocompatibility evaluation for prolonged tissue contact.
Are there surgical sutures excluded from this guidance scope?
Yes, excluded sutures include those with drug/biologic components, animal-derived materials, atypical design features (barbs, loops, anchors), specialized delivery tools, novel sterilization methods, and sutures intended for specific aesthetic or specialized cardiovascular applications.
What biocompatibility testing is required for surgical sutures?
Surgical sutures require evaluation for cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation effects, chronic toxicity, carcinogenicity, and hemocompatibility if contacting blood, following ISO 10993-1 standards.
Can oversized sutures still qualify for this pathway?
Yes, sutures not meeting USP diameter requirements may qualify if oversized by no more than one USP size. The labeling must clearly state “non-USP” and identify maximum oversize for each suture size in tabular format.
What You Need to Do 👇
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