Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
This guidance provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended for palliation of malignant strictures in the biliary tree. It does not apply to biliary stents for benign strictures or stents intended for vascular, tracheal/bronchial, or other gastrointestinal use.
Recommended Actions
- Conduct comprehensive non-clinical testing program including corrosion, mechanical, and functional testing
- Validate biocompatibility through testing or leveraging existing data
- Perform MR compatibility testing and develop appropriate labeling
- Develop and validate sterilization process and packaging
- Create compliant labeling with required warnings and limitations
- Prepare detailed device description and predicate comparison
- Consider if clinical data is needed based on device novelty
- Document all testing in format recommended in guidance appendix
- Ensure prominent display of “biliary” designation in labeling
- Validate shelf life through accelerated and real-time aging studies
Key Considerations
Clinical testing
- Generally not required unless for:
- Polymer covered designs
- Novel indications dissimilar from legally marketed devices
- Novel designs/sizes
- Different technology
- Removable stents
Non-clinical testing
- Stent corrosion resistance testing
- Dimensional verification
- Foreshortening evaluation
- Radial compression force testing
- Radial outward force testing (self-expanding stents)
- Delivery, deployment and withdrawal testing
- Balloon rated burst pressure (balloon expandable stents)
- Balloon fatigue testing (balloon expandable stents)
- Stent securement testing for unsheathed stents
Labeling
- Must prominently display “biliary” near trade name
- Device description with specifications
- Contraindications
- Warnings including vascular use limitation
- Precautions
- MRI safety information
- Clinical studies overview if applicable
- Potential adverse events
- Directions for use
- Patient labeling
Biocompatibility
- Testing required for:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material-mediated pyrogenicity
- Subacute/subchronic toxicity
- Chronic toxicity
- Implantation
Safety
- MR compatibility testing required
- Sterility validation
- Shelf life testing
- Package integrity testing
Other considerations
- Predicate comparison required
- Manufacturing process information needed for surface treatments
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- 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
Related references and norms
- ASTM F2129: Standard test method for conducting cyclic potentiodynamic polarization measurements
- ASTM G5: Standard reference test method for making potentiodynamic anodic polarization measurements
- ASTM F3044: Standard test method for evaluating the potential for galvanic corrosion for medical implants
- ASTM F2503: Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance Environment
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Original guidance
- Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- HTML / PDF
- Issue date: 2019-07-26
- Last changed date: 2024-08-09
- Status: FINAL
- Official FDA topics: Medical Devices, Gastroenterology-Urology, 510(k), Premarket
- ReguVirta summary file ID: 47513762fcf18d7e96a1ed6feb636863
This post is licensed under CC BY 4.0 by the author.