Premarket Notification Requirements for Esophageal and Tracheal Prostheses Including Metal Self-Expandable Stents
This guidance outlines the requirements for premarket notifications (510(k)) submissions for esophageal and tracheal prostheses, including metal self-expandable stents. It covers devices intended to restore the structure and/or function of the esophagus and trachea or trachealbronchial tree, along with their accessories and delivery systems.
Recommended Actions
- Prepare detailed device description and specifications
- Conduct comprehensive bench testing program
- Complete biocompatibility testing according to ISO-10993
- Validate sterilization process
- Develop complete labeling package
- Document comparison with predicate device
- Prepare materials and manufacturing information
- Consider need for animal/clinical testing based on device novelty
- Include certification statements and 510(k) summary/statement
- Ensure all test results are presented in clear tabular or graphical form
- Contact FDA before submission if significant differences from predicate device exist
Key Considerations
Clinical testing
- Clinical data may be required if technology/materials significantly differ from predicate device
- Contact FDA before submission if clinical testing might be needed
Non-clinical testing
- Deployment testing for largest diameter device
- Expansion force testing for representative device diameters
- Compression force testing for representative device diameters
- Dimensional testing for all diameter devices
- Corrosion testing with simulated gastric contents
- Tensile strength tests for bonded/welded components
- Animal testing required if technology/materials significantly differ from predicate device
Labelling
- Device name
- Indications for use
- U.S. point of contact
- Corporation details
- Sterility information
- Expiration date if applicable
- Single/multiple use statement
- Clear deployment and positioning instructions
- Warnings, precautions, contraindications
Biocompatibility
- Testing according to ISO-10993
- Cytotoxicity
- Sensitization
- Implantation
- Sub-chronic toxicity
- Chronic toxicity (for prostheses)
- Additional tests for delivery system: irritation/intracutaneous reactivity
Safety
- Sterility assurance level (SAL) of 10-6 required
- Sterilization validation method
- Packaging method description
- Residuals levels for sterilization agents if applicable
Other considerations
- Detailed device description with specifications
- Comparison with predicate device
- Materials identification and documentation
- Change/modification documentation if applicable
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Original guidance
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