Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
This guidance document addresses Class II pulse oximeter devices intended for non-invasive measurement of arterial blood oxygen saturation (SpO2) and pulse rate. It covers both transmittance and reflectance technologies used in various application sites (finger, ear, foot, hand, forehead, back, nose). The devices are limited to prescription use and can be continuous or spot-checking devices, either stand-alone or multi-parameter modules.
What You Need to Know? 👇
What are the key accuracy requirements for pulse oximeter 510(k) submissions?
FDA recommends following ISO 80601-2-61:2011 standards with Arms specifications of ≤3.0% for transmittance sensors, ≤3.5% for ear clip and reflectance sensors. Clinical studies should include 200+ data points from 10+ subjects with diverse skin pigmentations, including at least 2 darkly pigmented subjects.
When is a new 510(k) required for pulse oximeter modifications?
A new 510(k) is required for significant electro-optical sensor modifications (component changes in light path, extensive redesign/miniaturization) or significant SpO2 algorithm modifications. These changes could significantly affect safety or effectiveness and require clinical validation studies under IDE regulations.
What biocompatibility testing is needed for pulse oximeter sensors?
Patient-contacting materials require irritation/intracutaneous reactivity, sensitization, and cytotoxicity testing per ISO-10993. Pulse oximeters are considered prolonged contact devices due to cumulative use potential. Identical materials from predicate devices may reference existing biocompatibility data.
How should pulse oximeter accuracy be validated for neonatal use?
Adult subject testing is acceptable for neonatal sensors due to measurement uncertainties. For new/significantly changed neonatal sensors, additional convenience arterial samples from neonates verify clinical performance. Studies should justify sample size and SaO2 range limitations.
What documentation is required for reprocessed single-use pulse oximeter sensors?
Complete reprocessing validation per FDA guidance including component identification, performance testing after maximum reprocessing cycles, cleaning/sterilization validation, tracking methods for reprocessing cycles, and worst-case testing scenarios. Clinical validation of SpO2 accuracy is required.
What labeling specifications must be included for pulse oximeter 510(k) submissions?
Labeling must include SpO2 accuracy specifications (70-100% range), discrete range specifications (70-80%, 80-90%, 90-100%), graphical plots with regression fit, pulse rate accuracy, operating conditions, alarm limits, and identification of clinically validated pulse oximeter models for sensor compatibility.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive performance testing according to ISO 80601-2-61:2011
- Perform clinical validation studies for SpO2 accuracy
- Complete biocompatibility testing for patient-contacting materials
- Develop and validate cleaning/disinfection procedures for reusable devices
- Prepare comprehensive labeling including all required specifications and instructions
- Submit software documentation appropriate for moderate level of concern
- Conduct electrical and mechanical safety testing
- Validate EMC compliance
- For reprocessed devices, validate reprocessing procedures and performance after maximum cycles
- Prepare detailed device description comparing to predicate device
Key Considerations
Clinical testing
- In vivo testing required for SpO2 accuracy under laboratory conditions with minimum 10 healthy subjects and 200 data points
- Additional convenience arterial samples needed for neonatal sensors
- Clinical validation required for reprocessed single-use sensors
- Study must be conducted under IDE regulations if needed to demonstrate substantial equivalence
Non-clinical testing
- Performance testing according to ISO 80601-2-61:2011 requirements
- Bench testing for pulse rate accuracy using functional testers
- Testing under low perfusion conditions if claimed
- Testing under motion conditions if claimed
- Validation of cleaning and reprocessing methods for reusable devices
Human Factors
- Instructions should encourage local/institutional training programs
- Clear instructions for device setup and operation
- Instructions for frequency of inspection of application site
- Instructions for frequency of sensor relocation
Software
- Moderate level of concern documentation required
- Software validation according to FDA guidance
- Additional documentation needed for off-the-shelf software
Labeling
- Clear identification of intended use, patient populations, and environments
- Complete device specifications including accuracy data
- Cleaning/disinfection instructions for reusable devices
- Package labeling requirements
- Warnings and precautions
- Operating instructions
Biocompatibility
- Testing required for patient-contacting materials
- Considered prolonged contact duration
- Testing should include:
- Irritation/intracutaneous reactivity
- Sensitization
- Cytotoxicity
Safety
- Electrical safety testing for Type BF or CF applied parts
- Electromagnetic compatibility testing
- Environmental safety testing
- Mechanical safety testing
Other considerations
- Alarms requirements for continuous monitoring devices
- Display values and indicators validation
- Packaging validation for sterile devices
- Shelf-life validation if provided sterile
Relevant Guidances 🔗
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- 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
- Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
- HTML / PDF
- Issue date: 2013-03-03
- Last changed date: 2025-01-31
- Status: FINAL
- Official FDA topics: Premarket, Pediatric Product Development, Medical Devices
- ReguVirta ID: 8758ae8301ea1c620de1243d0f88b60e