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Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements

This guidance document provides information for manufacturers preparing 510(k) submissions for Biological Indicators (BIs) intended to monitor sterilization processes used in healthcare facilities. BIs are Class II medical devices that accompany products being sterilized to monitor sterilization adequacy by demonstrating growth or no growth of known microorganisms. The guidance excludes physical/chemical sterilization indicators, BIs for manufacturing settings, and BIs for liquid chemical sterilization.

  1. Conduct comprehensive performance testing including:
    • Viable spore population assays
    • Resistance characteristics studies
    • Materials evaluation
    • Recovery protocol validation
  2. Prepare detailed device documentation:
    • Device comparison to predicate
    • Complete specifications
    • Test protocols and results
    • Shelf life data
  3. Develop compliant labeling with:
    • Clear intended use statement
    • Complete device description
    • Detailed instructions for use
    • Required precautions
  4. Validate any associated components (incubators, test packs)
  5. Ensure conformity with applicable standards and maintain documentation in design history file
  6. Consider submitting preliminary shelf life data with ongoing study protocol if complete real-time data not available

Key Considerations

Non-clinical testing

  • Viable spore population assay to demonstrate product meets specifications
  • Resistance characteristics study using resistometer (D-value, Z-value for thermal processes, Survival/Kill window)
  • Carrier and primary packaging materials evaluation
  • Holding time assessment
  • Recovery protocols validation
  • Mail-in protocols validation if applicable

Labeling

  • Must include intended use (sterilization method, cycle, exposure time, temperature, sterilant concentration)
  • Device description (genus/species/strain, lot number, type of BI, D-value, Z-value, survival/kill time, spore count)
  • Instructions for use (sterilization parameters, result interpretation, disposal, recovery)
  • Precautions regarding D-value reproducibility

Safety

  • Demonstrate specifications maintained throughout labeled shelf life
  • Evaluate effect of sterilization process on recovery medium for self-contained BIs
  • Validate incubator performance if sold as system

Other considerations

  • ANSI/AAMI/ISO TIR11139:2006: Sterilization of health care products-Vocabulary
  • ANSI/AAMI/ISO ST11138-1:2006: Sterilization of health care products-Biological indicators-Part 1: General requirement
  • ANSI/AAMI/ISO ST11138-4:2006: Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes
  • ISO 18472:2006: Sterilization of health care products Biological and Chemical Indicators Test Equipment

Original guidance

  • Biological Indicators for Healthcare Facility Sterilization Process Monitoring - 510k Submission Requirements
  • HTML / PDF
  • Issue date: 2007-10-04
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 696240d8ff9252ac1189922b1899d91c
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