Endoscope Washers and Washer/Disinfectors - 510k Review Requirements
This guidance establishes the 510(k) review requirements for endoscope washers, washer/disinfectors intended for use in healthcare facilities (hospitals, clinics, healthcare professional offices). It covers electromechanical and microprocessor-controlled devices used to process endoscopes that are not normally used in sterile areas of the body, cannot be terminally sterilized, or where professional standards permit high-level disinfection. Manual endoscopic cleaning accessories are excluded from this guidance.
What You Need to Know? 👇
What are the key regulatory requirements for submitting a 510(k) for automated endoscope washers?
Manufacturers must submit comprehensive performance data including process parameter tests, simulated-use testing, and in-use clinical testing. The submission must demonstrate that the device safely and effectively cleans and disinfects endoscopes when used with legally marketed accessories according to labeling instructions.
How should manufacturers address accessories like detergents and germicides in their 510(k) submission?
If accessories are already legally marketed medical devices, supplemental performance data must be submitted showing system compatibility. For non-legally marketed accessories, comprehensive data establishing substantial equivalence is required. The washer must be specifically labeled for use with identified compatible accessories.
What types of performance testing are required for endoscope washer/disinfector validation?
Three types of testing are mandatory: process parameter tests demonstrating the machine meets physical specifications, simulated-use tests evaluating worst-case microbiological and chemical conditions, and in-use clinical testing with actual patient-used endoscopes to demonstrate real-world effectiveness.
What software documentation requirements apply to automated endoscope washers under 510(k) review?
Automated endoscope washers are considered “major” risk category devices requiring comprehensive software validation documentation. This includes validation protocols, risk analysis, and demonstration that software controls consistently meet predetermined specifications according to FDA’s Software Reviewers Guide.
How must manufacturers evaluate chemical residues remaining on endoscopes after processing?
A toxicological evaluation must assess residue levels from detergents and germicides remaining after processing. This includes reviewing available toxicity data, demonstrating residues are removed to nontoxic levels, and proving no harmful accumulation occurs over the endoscope’s use-life.
What specific labeling requirements must be included in the user’s manual for endoscope washers?
The manual must specify compatible endoscope brands/models, operational instructions for all modes, chemical preparation and monitoring procedures, pre/post-processing recommendations, error indications, maintenance schedules, and warnings. It must complement endoscope manufacturer instructions and include precleaning recommendations with supporting justification.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive test protocols for process validation including:
- Process parameter testing
- Simulated-use testing under worst case conditions
- In-use clinical testing
- Prepare detailed documentation including:
- Complete device description and specifications
- Software validation documentation
- Toxicological evaluation of residues
- Comparison to predicate devices
- Create comprehensive labeling including:
- Detailed user manual
- Service manual
- Installation requirements
- Compatible accessories list
- Validate compatibility with identified accessories:
- Detergents
- Enzyme cleaners
- Disinfectants
- Establish quality control measures for:
- Process monitoring
- Maintenance requirements
- Error detection/handling
- Prepare 510(k) submission package following guidance structure and requirements
- Maintain documentation of all testing and validation activities for potential FDA requests
Key Considerations
Clinical testing
- In-use testing required with actual patient-used scopes
- Must evaluate major types of scopes indicated in labeling
- Requires statistically derived sample size for each scope type
- Must include control and treated scopes
- Need microbiological data on bioburden loads before/after use
- Statistical evaluation of results required
Non-clinical testing
- Process parameter tests showing machine maintains specified parameters
- Simulated-use tests under worst case conditions
- Evaluation of washing effectiveness
- Testing of disinfection phase effectiveness
- Validation of rinse phases
- Testing of any additional parameters (alcohol rinse, air drying, etc.)
- Combined process effectiveness testing
Software
- Software validation required
- Considered “major” risk category
- Must follow FDA Software Reviewers Guide requirements
Labelling
- User manual requirements including:
- Intended use
- Compatible endoscope models
- Limitations of use
- Installation instructions
- Operating instructions
- Chemical preparation/handling
- Pre/post processing recommendations
- Error indications
- Maintenance requirements
- Service manual requirements
Safety
- Must evaluate toxicological residues
- Assessment of residue levels after processing
- Demonstration of residue removal to non-toxic levels
- Evaluation of residue accumulation over device life
Other considerations
- Must identify compatible accessories (detergents, enzyme cleaners, disinfectants)
- Installation requirements (electrical, plumbing, venting)
- Process monitoring capabilities
- Comparison to legally marketed predicate devices
Relevant Guidances đź”—
- Regulatory Requirements for Medical Device Washers and Washer-Disinfectors
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms đź“‚
- UL 544: Medical Electrical Equipment