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Premarket Notification Requirements for Sterile Lubricating Jelly Used with Transurethral Surgical Instruments

This guidance outlines the requirements for submitting a 510(k) premarket notification for sterile lubricating jelly used with transurethral surgical instruments. It covers administrative requirements, device description, testing requirements, and comparison to predicate devices.

  1. Compile comprehensive device description including all ingredients and their functions
  2. Develop and execute physical testing plan covering stability and effectiveness
  3. Conduct complete biocompatibility testing program or provide evidence of equivalent formulation
  4. Establish and validate sterilization process
  5. Prepare complete labeling package meeting all requirements
  6. Identify suitable predicate device and prepare detailed comparison
  7. Document all test results and prepare 510(k) summary
  8. Ensure compliance with prescription device requirements
  9. Verify packaging maintains sterility
  10. Submit complete 510(k) application with all required administrative information

Key Considerations

Non-clinical testing

  • Physical testing requirements:
    • Preservative effectiveness
    • Stability analysis (pH, viscosity, H2O solubility, lubricity)
    • Antimicrobial effectiveness (if applicable)

Labelling

  • Must include instructions for use
  • Intended use statement
  • Prescription device statement (21 CFR 801.109)
  • Single use labeling
  • Sterility indication
  • Solubility statement (water-soluble or petroleum based)
  • Quantity of jelly provided

Biocompatibility

  • Required testing on final formulation:
    • Mucosal irritation test
    • Sensitization test
    • Cytotoxicity test
    • Acute systemic toxicity test
    • Short-term implantation test

Safety

  • Sterility requirements:
    • Sterilization method and validation
    • Sterility assurance level (SAL)
    • Residuals testing (if applicable)
    • Packaging validation
    • Pyrogenicity testing (if claimed)

Other considerations

  • 21 CFR 876.1500: Endoscope and accessories
  • 21 CFR 801.109: Prescription devices labeling

Original guidance

  • Premarket Notification Requirements for Sterile Lubricating Jelly Used with Transurethral Surgical Instruments
  • HTML
  • Issue date: 1994-09-18
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 2e5eff3cabd13272d65f7661ebf1eb34
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