Aqueous Shunts for Glaucoma Treatment - Testing and Documentation Requirements
This guidance serves as a special control for the regulation of aqueous shunts through 510(k) submissions. It applies to implantable devices intended to reduce intraocular pressure in the anterior chamber of the eye, specifically for neovascular glaucoma or glaucoma where medical and conventional surgical treatments have failed.
What You Need to Know? 👇
What are the key biocompatibility requirements for aqueous shunt 510(k) submissions?
Aqueous shunts require comprehensive biocompatibility testing including intramuscular implantation, animal ocular implantation (6 months minimum), cytotoxicity tests, sensitization testing, intracutaneous testing, and mutagenicity evaluation. These tests assess biological safety and toxicity of materials that may leach from the device.
What clinical data is required for aqueous shunt 510(k) submissions?
Clinical data must confirm device performance with minimum 50 subjects and one-year follow-up. Aqueous shunts are significant risk devices requiring IDE for US studies. New devices need clinical investigations, while devices with established clinical history may use published studies demonstrating safety and effectiveness.
What are the pressure/flow testing requirements for aqueous shunts?
Devices must demonstrate pressure/flow characteristics substantially equivalent to predicate devices. Testing includes gravity flow tests, constant flow tests, and valve open/close pressure evaluations. The shunt must be leak-free and valved devices must meet designed opening/closing pressure tolerances in aqueous environments.
What sterilization validation is required for aqueous shunt devices?
Sterilization must be validated using appropriate methods: steam sterilization per ANSI/AAMI/ISO 11134-1993, ethylene oxide per ANSI/AAMI/ISO 11135-1994 with specific EO residual limits, or radiation per ANSI/AAMI/ISO 11137. Devices should be terminally sterilized in final containers when possible.
What are the dimensional and surface quality specifications for aqueous shunts?
Components must be free from pits, scratches, cracking, and crazing at 6x magnification. Edges should be smooth without burrs or flash. Overall dimensions and drainage area must be within ±5% of design nominal, while tube diameters must be within 15% of design specifications.
What labeling information is mandatory for aqueous shunt devices?
Required labeling includes manufacturer name, trade name, material description with dimensional diagrams, lot/batch number, indications for use, instructions, clinical results including adverse events, sterility warnings, handling precautions, and single-use statements per 21 CFR Part 801 requirements.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive test plan covering all physical, chemical and biological requirements
- Design and execute clinical study with minimum 50 subjects
- Establish sterilization validation protocol
- Prepare detailed packaging validation plan
- Create complete labeling documentation
- Develop biocompatibility testing strategy
- Establish shelf-life validation program
- Prepare pressure/flow characterization testing protocol
- Document all dimensional and surface quality inspections
- Create detailed adverse event tracking system for clinical study
Key Considerations
Clinical testing
- Minimum 50 subjects with one-year follow-up
- Standardized evaluation criteria for adverse events, IOP, visual acuity
- Specific reporting periods required (1-3 days, 7-35 days, 150-210 days, 330-420 days post-op)
- Detailed tracking of intraoperative and postoperative adverse events
Non-clinical testing
- Physical stability testing after 14 days immersion at 37°C
- Pressure/flow characteristics testing
- Structural integrity testing (0.5N force resistance)
- Chemical testing for residual monomers
- Aqueous aging test for one-year stability
- Dimensional and surface quality inspection at 6x magnification
Labelling
- Name of manufacturer and trade name
- Device description and dimensions
- Lot/batch number
- Indications for use
- Instructions for use
- Clinical results including adverse events
- Sterilization warning
- Handling precautions
- Single use statement
Biocompatibility
- Intramuscular implantation testing
- Animal ocular implantation (6 animals, 6-month data)
- Cytotoxicity testing
- Sensitization testing
- Intracutaneous testing
- Mutagenicity testing
Safety
- Sterilization validation required
- Package integrity testing
- Shelf-life validation
Other considerations
- Packaging must protect device and maintain sterility
- Real-time aging preferred for shelf-life determination
- Accelerated aging up to 5 years may be acceptable for certain materials
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Submission Requirements for Terminally Sterilized Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms 📂
- ANSI/AAMI/ISO 11134-1993: Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
- ANSI/AAMI/ISO 11135-1994: Medical devices - Validation and routine control of ethylene oxide sterilization
- ISO 10993-7 (1995): Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ANSI/AAMI/ISO 11137: Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
- ISO 11607: Packaging for terminally sterilized medical devices