510k Submissions for Mechanical Lithotripters and Stone Dislodgers in Gastroenterology and Urology
This guidance outlines the requirements for 510(k) submissions for mechanical lithotripters and stone dislodgers used in gastroenterology and urology. These devices are intended for endoscopic grasping, manipulation, and removal of calculi and foreign objects, with mechanical lithotripters having the additional capability to crush stones.
What You Need to Know? 👇
What are the FDA classification codes for mechanical lithotripters and stone dislodgers?
Stone dislodgers include Ureteral (78 FFL), Flexible Urological (78 FGO), and Biliary (78 LQR) - all Class II. Mechanical lithotripters include Biliary (78 LQC) and Bladder Stone Tripsor (78 FGK) - both Class II devices under 21 CFR regulations.
What mechanical testing is required for 510(k) submission of stone dislodgers?
Required testing includes stone capture testing through simulated anatomical tubes, pull testing for tensile strength, flexibility testing for 90° deflection capability, and for lithotripters, calculi crush testing. All tests must be performed on final sterilized devices with predicate device comparison.
What biocompatibility tests are mandatory for these urological devices?
For materials contacting mucosal tissue or infusion fluids, required tests include mucosal irritation, sensitization assay, cytotoxicity, acute systemic toxicity, and short-term implantation tests. Tests must be conducted on final sterilized products unless equivalent materials are already cleared.
What sterility information must be included in the 510(k) submission?
Submissions must include sterilization method, validation cycle methodology, sterility assurance level (SAL), packaging materials description, and specific residual levels for EtO sterilization or radiation levels for gamma sterilization. Complete validation documentation is required.
What predicate device comparison requirements exist for these devices?
A detailed tabular comparison must include predicate device name/manufacturer, labeling, intended use, description, diagrams/photographs, 510(k) number, and similarities/differences analysis. Mechanical properties comparison from Section 6 testing must also be included for substantial equivalence demonstration.
Are reprocessing instructions required for reusable lithotripters and stone dislodgers?
Yes, if devices are intended for reuse, manufacturers must provide scientifically validated reprocessing instructions and evidence that devices can withstand multiple cleaning and sterilization cycles. Single-use devices must be clearly labeled as such.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including components, operation, and size ranges
- Conduct mechanical testing suite (stone capture, pull, flexibility, crush testing)
- Complete biocompatibility testing program for patient-contacting materials
- Validate sterilization processes and packaging
- Develop compliant labeling including all required statements
- Prepare detailed comparison to predicate devices
- Document reprocessing validation if device is reusable
- Compile administrative information and 510(k) Summary/Statement
- Ensure all test reports include detailed methodologies and results
- Verify all claims are supported by objective evidence
Key Considerations
Non-clinical testing
- Stone capture testing using simulated anatomical conditions
- Pull testing to determine minimum tensile load resistance
- Flexibility testing to verify 90° deflection capability
- Calculi crush testing (for mechanical lithotripters)
- Comparison testing with predicate devices
Labelling
- Include intended use statement
- Prescription device statement
- Single-use labeling (if applicable)
- Sterility labeling
- Reprocessing instructions (if applicable)
Biocompatibility
- List of all device materials
- For materials contacting mucosal tissue or infusion fluids:
- Mucosal irritation test
- Sensitization assay
- Cytotoxicity test
- Acute systemic toxicity
- Short term implantation test
Safety
- Sterilization validation
- Sterility assurance level (SAL)
- EtO residuals (if applicable)
- Radiation level (if applicable)
- Packaging validation for sterility maintenance
Other considerations
- Administrative information (manufacturer details, registration numbers)
- Device description including components and operation
- Comparison to legally marketed predicate devices
- 510(k) Summary/Statement
Relevant Guidances 🔗
- 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
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms 📂
- 21 CFR 876.4680: Ureteral Stone Dislodger
- 21 CFR 876.5010: Biliary Stone Dislodger
- 21 CFR 876.4500: Mechanical Lithotripter