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.
What You Need to Know? 👇
What is the FDA classification for sterile lubricating jelly used with transurethral surgical instruments?
Sterile lubricating jelly for transurethral surgical instruments is classified as an Accessory to Endoscope under Procode FHX 78, Class II device according to 21 CFR 876.1500.
What biocompatibility tests are required for sterile lubricating jelly 510(k) submissions?
The minimum required biocompatibility tests include mucosal irritation, sensitization, cytotoxicity, acute systemic toxicity, and short-term implantation tests on the final formulation, unless equivalent formulation data is available.
What sterility information must be included in a 510(k) submission for lubricating jelly?
Required sterility information includes sterilization method, validation protocol, sterility assurance level (SAL), residual levels (if applicable), packaging materials, and pyrogen-free testing methods if claimed.
What physical testing is required for sterile lubricating jelly devices?
Physical testing requirements include preservative effectiveness, stability analysis (pH, viscosity, water solubility, lubricity), antimicrobial effectiveness if applicable, and any other relevant tests with protocols and results.
What device description elements are mandatory for lubricating jelly 510(k) submissions?
Device description must include complete ingredient list with percentages, active/inactive ingredient identification, function of each ingredient, drug component identification if present, and explanation of mode of action.
What labeling requirements apply to sterile lubricating jelly for transurethral instruments?
Required labeling includes instructions for use, intended use statement, prescription device statement, single-use labeling, sterile designation, solubility description, and quantity information per 21 CFR requirements.
What You Need to Do 👇
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 ID: 2e5eff3cabd13272d65f7661ebf1eb34