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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.

  1. Prepare comprehensive device description including physical specifications and diagrams
  2. Conduct all required performance testing (flow rate, elongation, curl strength)
  3. Complete biocompatibility testing program for long-term mucosal contact
  4. Develop and validate sterilization process
  5. Prepare detailed labeling including all required elements
  6. Document material and color specifications
  7. If marketed as a kit, prepare component certification documentation
  8. Prepare Summary of Equivalence comparing to legally marketed devices
  9. Validate shelf life claims with supporting data
  10. 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

  • 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 summary file ID: 22c6f3e8e203c1c0c26bf77e08a6650f
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