Premarket Notification Requirements for Healthcare Facility Sterilizers
This guidance provides direction for 510(k) submissions for sterilizers intended for use in healthcare facilities like hospitals, clinics, and healthcare professional offices. It excludes sterilizers used in manufacturing, ionizing radiation technologies, pre-cleaning devices, sterilization wraps, contact lens sterilizers, and liquid chemical sterilizers.
What You Need to Know? 👇
What is the 510(k) premarket notification requirement for sterilizers used in healthcare facilities?
A 510(k) submission must be filed with FDA at least 90 days before introducing a sterilizer into interstate commerce. The submission must demonstrate substantial equivalence to a legally marketed predicate device and include comprehensive documentation of safety and effectiveness.
Which sterilizers are exempt from this FDA guidance document?
This guidance excludes sterilizers used in device manufacturing (regulated under GMPs), ionizing radiation technologies, precleaners, contact lens sterilizers, and liquid chemical sterilizing environments. It only covers sterilizers intended for healthcare facility use.
What biological indicators are required for validating different types of sterilizers?
Steam sterilizers require Bacillus stearothermophilus (ATCC 7953), while dry heat and ethylene oxide sterilizers use Bacillus subtilis var. niger (ATCC 9372 or 19659). Nontraditional sterilizers must test against a comprehensive battery of organisms.
What is the difference between overkill and bioburden-based sterilization for healthcare facilities?
Overkill sterilization uses arbitrarily high initial bioburden concentrations (typically 10⁶ CFU/unit) and is required for healthcare facilities where bioburden fluctuates. Bioburden-based sterilization uses predetermined contamination levels and is only appropriate for manufacturing settings.
What documentation is required for software-controlled sterilizers in 510(k) submissions?
Software documentation must follow FDA’s Software Reviewers Guide for 510(k) submissions. Sterilizers are typically considered “moderate” risk category devices, requiring appropriate software validation documentation including design controls, hazard analysis, and verification/validation protocols.
When is a new 510(k) submission required for changes to an existing sterilizer?
A new 510(k) is required for new model designations, changes in sterilization vessel dimensions, software/firmware modifications from mechanical controls, or changes to the specific sterilant used. These changes may significantly affect safety and effectiveness.
What You Need to Do 👇
Recommended Actions
- Determine if sterilizer technology is traditional (steam, dry heat, EtO) or non-traditional as requirements differ
- Develop comprehensive test protocol including:
- Biological performance testing
- Material compatibility testing
- Toxicity and residue testing
- Process validation
- Prepare detailed device description and specifications
- Create comprehensive labeling package
- Conduct software validation if applicable
- Verify EPA requirements if using regulated sterilants
- Complete process validation with 3 consecutive successful runs
- Document all test results and analyses thoroughly
- Use provided checklist to ensure submission completeness
- Consider pre-submission meeting with FDA for new technologies
Key Considerations
Non-clinical testing
- Must demonstrate sterilizer can achieve Sterility Assurance Level (SAL) of 10^-6 for all medical products listed in labeling
- Requires biological performance testing including:
- Sporicidal screening test (for non-traditional sterilizers)
- D-value determination
- Half cycle validation
- Total kill endpoint validation
- Simulated and in-use testing (for non-traditional sterilizers)
Software
- Software documentation required per FDA Software Reviewer’s Guide
- Sterilizers considered “moderate” risk category for software
Labeling
- Must include device markings, information manual, and service manual
- Information manual must detail:
- Intended use and limitations
- Installation and operating instructions
- Error indications and responses
- Monitoring instructions
- Warnings and precautions
Biocompatibility
- Must determine toxicity profile of sterilant and by-products
- Must establish residue levels and procedures to reduce to acceptable levels
- Material compatibility testing required for all claimed compatible materials
Safety
- Must include safety features and controls
- Must address toxic residues and by-products
- Must include appropriate warnings and precautions in labeling
Other considerations
- Process validation required with 3 consecutive successful runs
- Changes requiring new 510(k) include:
- New model numbers
- Chamber dimension changes
- Control system changes
- Sterilant changes
Relevant Guidances 🔗
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Liquid Chemical Sterilants and High Level Disinfectants - Content and Format of 510k Submissions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
Related references and norms 📂
- AAMI Sterilization Standards for steam and EtO
- ISO 194: Biological evaluation of medical devices
- ASTM standards for material testing