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Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions

This guidance provides recommendations for the content and format of 510(k) submissions for liquid chemical sterilants/high level disinfectants intended for sterilization and/or high level disinfection of reusable heat-sensitive critical and semicritical medical devices.

  1. Conduct complete AOAC Sporicidal Testing with three product lots
  2. Perform simulated-use and in-use testing under worst-case conditions
  3. Complete comprehensive biocompatibility assessment
  4. Validate material compatibility claims with appropriate testing
  5. Develop clear and complete labeling per guidance requirements
  6. Establish chemical indicator system for reusable products
  7. Generate stability data supporting shelf life claims
  8. Document cleaning validation and residue removal
  9. Create comprehensive training materials for users
  10. Prepare complete 510(k) submission addressing all guidance elements

Key Considerations

Non-clinical testing

  • Must pass AOAC Sporicidal Test for sterilant claim
  • Must demonstrate efficacy against mycobacteria for high-level disinfection claim
  • Must conduct simulated-use testing with appropriate microbial challenges
  • Must conduct in-use testing in clinical settings
  • Must demonstrate effectiveness under worst-case conditions

Human Factors

  • Users must be adequately trained in device reprocessing and handling toxic substances
  • Clear instructions must be provided for proper use and monitoring

Labelling

  • Must include essential information on bottle label (ingredients, intended use, warnings, precautions, etc.)
  • Must include comprehensive information in package insert
  • Must refer users to reusable device labeling
  • Must clearly state contact conditions and limitations

Biocompatibility

  • Must evaluate toxicity of germicide solution and residues
  • Must conduct appropriate biocompatibility testing (skin irritation, sensitization, cytotoxicity, etc.)
  • Must demonstrate safe residue levels after processing

Safety

  • Must include appropriate warnings and precautions
  • Must provide emergency contact information
  • Must include disposal instructions
  • Must address user safety during handling

Other considerations

  • ANSI/AAMI/ISO 11134-1993: Sterilization of Healthcare Products – Requirements for Validation and Routine Control
  • ISO 10993-1:1992: Biological evaluation of medical devices - Part 1: Evaluation and Testing

Original guidance

  • Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
  • HTML / PDF
  • Issue date: 2000-01-02
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: d6c29e1f99fa5b73e08296173cca896d
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