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.
Recommended Actions
- Compile comprehensive device description including all ingredients and their functions
- Develop and execute physical testing plan covering stability and effectiveness
- Conduct complete biocompatibility testing program or provide evidence of equivalent formulation
- Establish and validate sterilization process
- Prepare complete labeling package meeting all requirements
- Identify suitable predicate device and prepare detailed comparison
- Document all test results and prepare 510(k) summary
- Ensure compliance with prescription device requirements
- Verify packaging maintains sterility
- 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
- Device description requirements:
- List of ingredients with quantities
- Active/inactive ingredients identification
- Function of each ingredient
- Drug components identification (if any)
- Comparison to predicate devices required
- 510(k) summary/statement needed
Relevant Guidances
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- 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
Related references and norms
- 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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