Pulse Oximeter Validation Testing

At Element, we test pulse oximetry equipment for the healthcare industry and wearable technologies, validating devices that monitor oxygen saturation levels for both clinical and consumer applications. Our testing accommodates all pulse oximetry systems, to help physicians make informed decisions and monitor overall health.

Our experienced team will take care of protocol design, IRB submission and management, recruitment and payment of participants, study performance, analysis of data, and assemble high-quality data packages for validation studies, ready for regulatory submission.

The most commonly tested oxygen saturation range is between 70-100%. Oxygen levels are gradually reduced to 70% and analyzed at several plateaus using a blood co-oximeter. This data is then compared to readings from the pulse oximeter being tested.

The SpO2 accuracy of the test pulse oximeter is evaluated under highly controlled conditions, comparing the device’s performance against arterial blood samples assessed by CO-Oximetry within the specified oxygen saturation range (typically 70-100% SaO2).

Study Enrollment and Process:
Each study enrolls a minimum of 15 healthy, non-smoking adults with diverse pigmentation, meeting ISO 80601-2-61 and FDA requirements. Participants rest comfortably in a reclined position, with an arterial catheter placed in the radial artery. Medical-grade oxygen and nitrogen are used to induce hypoxia, with stepwise, stable plateaus down to the minimum target SaO2 level. Data is collected from multiple pulse oximeters simultaneously, and blood samples are analyzed using CO-Oximeters at stable plateaus.

Pulse Ox Clinical Validation for Regulatory Submission:
After completing the clinical validation study, Element provides data in formats that meet or exceed ISO 80601-2-61 requirements. We perform statistical comparisons between the test device and reference CO-Oximeters, ensuring high accuracy. Our experts offer guidance throughout the regulatory process, including serving as an extension of your team during discussion with regulatory bodies.

We utilize multiple CO-Oximeters for high-accuracy reference data, automated computer recording systems, and medical-grade oxygen and nitrogen gas mixtures for precise testing control. Our equipment enables continuous monitoring throughout stable plateaus, ensuring reliable data collection at each testing stage.

Element Boulder specializes in clinical validation testing for medical devices and wearables.  For more than three decades, we have proudly served as the premier clinical testing and regulatory validation partner to the medical device, wearables and consumer electronic industries.

Our recognized and published industry leaders are primary authors of monitoring equipment guidance documents, with three decades of experience as the premier clinical testing and regulatory validation partner. We maintain substantial expertise in the physiological monitoring space through our network of fully equipped labs and associate hospitals to support comprehensive testing needs.