Ureteral Stents - Content and Testing Requirements for 510k Submissions
This guidance outlines the requirements for premarket notifications (510(k)) submissions for ureteral stents, which are Class II medical devices used to provide ureteral rigidity and allow urine passage in the treatment of ureteral injuries and obstructions.
What You Need to Know? 👇
What are the key regulatory requirements for ureteral stent 510(k) submissions?
Ureteral stents require Class II 510(k) submissions including device description, predicate comparison, labeling, biocompatibility data, performance testing (flow rate, tensile strength, curl strength), sterilization validation, and substantial equivalence demonstration per 21 CFR 807.87.
What biocompatibility testing is required for ureteral stents as long-term implants?
Ureteral stents require comprehensive biocompatibility testing including mucosal irritation, sensitization, cytotoxicity, chronic systemic toxicity, and implantation studies. Testing duration should reflect the recommended implant duration specified in device labeling.
What performance tests must be conducted for ureteral stent 510(k) clearance?
Required performance tests include flow rate testing (per ASTM F-623-89), elongation/yield and tensile strength testing (ASTM D412), curl strength testing, and optional coefficient of friction testing for coated devices. All tests require statistically valid sample sizes.
How should manufacturers demonstrate substantial equivalence for modified ureteral stents?
Manufacturers must provide detailed comparison tables showing similarities and differences with predicate devices, including intended use, design specifications, materials, and performance data. Any modifications affecting safety or effectiveness require supporting clinical or scientific studies.
What labeling requirements apply to ureteral stents and accessories?
Labels must include device name, intended use, directions for use, contraindications, warnings, sterility status, expiration date, size specifications, maximum implant duration, and the required physician caution statement per 21 CFR 801.109(b)(1).
What sterilization documentation is needed for sterile ureteral stents?
Complete sterilization information must include validation method, packaging materials, sterility assurance level (SAL), radiation dose or ethylene oxide residual levels, and pyrogen testing methods if labeled pyrogen-free. Non-sterile devices require reprocessing instructions.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including physical specifications and diagrams
- Conduct all required performance testing (flow rate, elongation, curl strength)
- Complete biocompatibility testing program for long-term mucosal contact
- Develop and validate sterilization process
- Prepare detailed labeling including all required elements
- Document material and color specifications
- If marketed as a kit, prepare component certification documentation
- Prepare Summary of Equivalence comparing to legally marketed devices
- Validate shelf life claims with supporting data
- Ensure all test samples are sterilized using the validated process before testing
Key Considerations
Non-clinical testing
- Flow rate testing at body temperature in simulated body fluid
- Elongation/yield and tensile strength testing
- Curl strength testing to demonstrate resistance to migration
- Coefficient of friction testing (optional for uncoated catheters)
- Shelf life/expiration date testing
Labelling
- Device name, U.S. point of contact, corporation details on package label
- Sterility status, expiration date, disposable/single use information
- Maximum implant duration
- Specific indications and target population
- Comprehensive instructions for preparation, placement, and removal
- Contraindications, precautions, and warnings
- Troubleshooting procedures
Biocompatibility
- Testing for long-term mucosal contacting implant including:
- Mucosal irritation
- Sensitization
- Cytotoxicity
- Chronic systemic toxicity
- Implantation testing
Safety
- Sterilization validation and sterility assurance level (SAL)
- Pyrogen testing if labeled as pyrogen-free
- Maximum residual levels for ethylene oxide sterilization
Other considerations
- Physical description with labeled diagrams
- Material identification and processing details
- Color identification and processing
- Kit components certification if marketed as a kit
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms 📂
- ASTM F-623-89: Standard test method for flow rate testing
- ASTM D412: Standard test methods for vulcanized rubber and thermoplastic elastomers
- ASTM D1894: Standard test method for static and kinetic coefficients of friction
Original guidance
- Ureteral Stents - Content and Testing Requirements for 510k Submissions
- HTML
- Issue date: 1993-02-09
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta ID: 22c6f3e8e203c1c0c26bf77e08a6650f