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.
What You Need to Know? 👇
What are the key biocompatibility tests required for surgical mesh 510(k) submissions?
The FDA requires cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation with histology, hemolysis, and pyrogenicity testing. For devices remaining in the body over 30 days, additional subchronic and chronic toxicity studies are needed.
What sterilization validation requirements apply to surgical meshes?
Manufacturers must specify sterilization method, validation approach, sterility assurance level (typically 10⁻⁶), and lot monitoring procedures. For animal-derived materials, viral inactivation validation demonstrating at least 6-log reduction is required.
What physical characterization data is needed for surgical mesh equivalence determination?
Essential parameters include mesh thickness, weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pullout strength, burst strength, and tear resistance. Comparative data with predicate devices must be provided.
Are there specific residual limits for ethylene oxide sterilized surgical meshes?
Yes, FDA specifies maximum residual levels based on implant size: small devices (<10g) allow 250 ppm ethylene oxide and ethylene chlorohydrin, 5,000 ppm ethylene glycol. Limits decrease for medium and large devices.
What additional requirements apply to animal-derived surgical mesh materials?
Manufacturers must identify species/tissue source, document herd health monitoring, provide BSE-free certification for bovine materials, describe animal health protocols, and validate viral inactivation processes throughout manufacturing and sterilization.
Can surgical meshes be labeled for adhesion prevention without additional approval?
No, surgical meshes cannot be labeled as treatments for reducing post-surgical adhesions. This indication requires a Premarket Approval (PMA) application rather than 510(k) clearance, representing a higher regulatory pathway.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive physical and material characterization testing plan
- Establish biocompatibility testing program based on device classification
- Implement sterilization validation program with appropriate SAL
- For animal-derived materials, establish viral inactivation validation protocol
- Create stability testing program for shelf-life determination
- Prepare detailed device description including all material components
- Develop labeling that complies with requirements and restrictions
- Document manufacturing process including all reagents and processing steps
- Create specifications for in-process and final product testing
- 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
- Stability data supporting expiration dating required from 3 production lots
- For biodegradable devices:
- Must document resorption rate
- Changes in device properties over time
- Special considerations for devices formed in-situ
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
- Shelf Life and Stability Testing for Medical Devices
Related references and norms 📂
- 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