Chemical Indicators for Sterilization Process Monitoring in Healthcare Facilities - Content and Format Requirements for 510k Submissions
This guidance provides recommendations for the content and format of 510(k) submissions for chemical indicators intended to monitor sterilization processes in healthcare facilities. It covers three types of chemical indicators: - Process indicators - Chemical integrators - Air removal indicators for test packs
Recommended Actions
- Prepare detailed device description and comparison to predicate
- Conduct performance testing in resistometer
- Perform biocompatibility assessment
- Complete shelf life and endpoint stability validation
- Develop comprehensive labeling according to requirements
- Prepare test data for specific indicator type (process, integrator, or air removal)
- Document all testing in design history file
- Submit complete 510(k) with checklist items addressed
- Include samples of unprocessed and processed indicators if feasible
- Consider ongoing shelf life studies if needed for clearance
Key Considerations
Non-clinical testing
- Performance testing in resistometer showing reaction to critical parameters
- Side-by-side testing with biological indicators for chemical integrators
- Endpoint stability testing throughout shelf life
- Testing at least 3 lots from 3 different manufacturing runs
- For air removal indicators: testing in Bowie Dick Test Pack configuration
Labelling
- Clear description of physical/chemical changes and endpoints
- Storage conditions and expiration date
- Performance characteristics
- Interfering substances/conditions
- Safety precautions
- For Bowie Dick Test: specific warnings about timing and empty chamber use
Biocompatibility
- Demonstrate no toxic substances leaching onto surgical instruments
Safety
- Demonstrate endpoint stability
- Show no release of toxic substances
Other considerations
- Device comparison to predicate
- Detailed device description including chemical composition
- Shelf life validation
- Critical parameters identification for each sterilization method
Relevant Guidances
- Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- ANSI/AAMI ST 41:1992: Good Hospital Practice: Ethylene Oxide Sterilization and Sterility Assurance
- ANSI/AAMI ST 44:2002: Resistometers for Characterizing the Performance of Biological and Chemical Indicators
- ANSI/AAMI ST 60:1996: Sterilization of Health Care Products - Chemical Indicators, Part 1: General Requirements
- ANSI/AAMI ST 66:1999: Sterilization of Health Care Products – Chemical Indicators – Part 2: Class 2 Indicators for Air Removal Test
- ANSI/AAMI/ISO TIR 11139:2002: Sterilization of Health Care Products - Vocabulary
Original guidance
- Chemical Indicators for Sterilization Process Monitoring in Healthcare Facilities - Content and Format Requirements for 510k Submissions
- HTML / PDF
- Issue date: 2003-12-18
- Last changed date: 2020-03-19
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 7398de3c3de4fc08c9ced5948d0ec5fb
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