Pulse Oximeters - Premarket Notification Submissions 510k
This guidance applies to Class II pulse oximeter devices intended for non-invasive measurement of arterial blood oxygen saturation (SpO2) and pulse rate through various application sites (finger, ear, foot, hand, forehead, back, nose). It covers both continuous monitoring and spot-checking devices, either as stand-alone units or multi-parameter modules. The devices are limited to prescription use.
Recommended Actions
- Determine device classification and applicable product codes
- Plan and execute clinical validation studies:
- SpO2 accuracy testing with required subject diversity
- Additional studies for special claims (motion, low perfusion)
- Neonatal validation if applicable
- Complete comprehensive performance testing:
- Pulse rate accuracy
- Display and alarm functions
- Environmental conditions
- EMC testing
- Prepare biocompatibility assessment and testing
- Develop and validate software according to moderate level of concern requirements
- Create complete labeling package with:
- Clear intended use
- Detailed instructions
- Performance specifications
- Required warnings/cautions
- Prepare cleaning/disinfection validation if reusable
- Document sterilization processes if provided sterile
- Include additional documentation for reprocessed sensors if applicable
- Compile 510(k) submission with all required testing and documentation
Key Considerations
Clinical testing
- In vivo testing required for SpO2 accuracy under laboratory conditions with 10+ healthy subjects
- 200+ data points distributed across 70-100% SpO2 range
- Include subjects with range of skin pigmentations (at least 2 darkly pigmented or 15% of pool)
- Additional convenience sample testing required for neonatal use
- Clinical testing needed for motion claims validation
Non-clinical testing
- Bench testing required for pulse rate accuracy
- Testing needed for low perfusion claims
- Functional tester validation for OEM technology integration
- Performance testing for all data outputs, measurements and indicators
Software
- Moderate level of concern software documentation required
- Software validation per FDA guidance
- Additional documentation needed for off-the-shelf software
Labeling
- Clear intended use statement including patient populations and environments
- Instructions for use with safety information and device operation details
- Device specifications including accuracy data and plots
- Package labeling requirements for sterile/non-sterile status
- Reprocessing instructions if applicable
Biocompatibility
- Testing required for skin-contacting materials:
- Irritation/intracutaneous reactivity
- Sensitization
- Cytotoxicity
Safety
- Electrical safety testing for Type BF/CF applied parts
- EMC testing required
- Environmental safety testing needed
Other considerations
- Cleaning/disinfection validation for reusable devices
- Sterilization documentation if provided sterile
- Additional requirements for reprocessed single-use sensors
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms
- ISO 80601-2-61:2011: Medical Electrical Equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ANSI/AAMI/ISO 11607-1-2:2006: Packaging for terminally sterilized medical devices – Parts 1 and 2
- IEC 60601-1:2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Original guidance
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