Element’s human testing of pulse oximeters provides real-world data that is not possible with the use of simulators. Turn-key solutions support the development of algorithms and hardware used in pulse oximetry to pulse oximeter validation for regulatory submission. Bringing optimized pulse oximeters to market faster with invaluable physiological and human factor data.
Pulse Oximetry is a noninvasive method for assessment of oxygen saturation levels. Oxygen saturation levels are one of the critical vital signs of life, with normal levels at 92-100%. Pulse oximeters have been widely used in the healthcare industry, helping physicians make informed decisions and monitor overall health. Wearable technologies, such as smart watches and smart devices, are routinely integrating these sensors.
Pulse oximeter clinical validation study overview
Your entire pulse ox clinical validation study will be conducted by Element. Our experienced team will take care of protocol design, IRB submission and management, recruitment and payment of participants, study performance, analysis of data, and for validation studies, assembling high-quality data packages ready for regulatory submission.
The most tested oxygen saturation level is between 70-100%. Oxygen saturation levels are decreased stepwise down to 70% and analyzed at multiple plateaus by a blood co-oximeter. This data is then compared to data being collected by the pulse oximeter device being tested.
SpO2 accuracy performance of the test pulse oximeter will be evaluated in highly controlled conditions over the specified range of oxygen saturation (typically 70-100% SaO2) while being compared to arterial blood samples assessed by CO-Oximetry.
How pulse oximeter clinical validation studies are conducted
A minimum of 15, healthy non-smoking adult participants, ranging in pigmentation from light to dark, are enrolled in each study. This ensures study design requirements will be met, defined by ISO 80601-2-61 and FDA guidance documents.
While participants rest comfortably in a reclined position, an arterial catheter is placed in the radial artery. A gas mixture of medical grade oxygen and nitrogen is administered to participants to induce hypoxia in a series of stair-stepped, stable plateaus down to the minimum target SaO2 level based on the specified range for the test pulse oximeter.
Data is collected from all pulse oximetry systems simultaneously. The oxygen saturation (SpO2) and pulse rate values are automatically recorded via computer from each pulse oximetry system. At each stable plateau, blood samples are drawn during non-motion conditions and immediately analyzed on multiple CO-Oximeters. Want to know more? Get in touch with our team today.
Pulse ox clinical validation study data formatted for regulatory agencies
Upon completion of a clinical validation study for regulatory submission, Element will deliver data in formats that meet or exceed current the requirements outlined in ISO 80601-2-61. Study data is analyzed to derive a statistical comparison between the test device and reference CO-Oximeters. Furthermore, multiple co-oximeters are utilized simultaneously to provide a high degree of accuracy for the reference data. Throughout the regulatory process, our experts will guide and advise you, including during discussions with regulatory bodies, serving as an extension of your team.
The Element advantage
Our recognized and published industry leaders are among the primary authors of multiple monitoring equipment guidance documents and test specifications, including Batchelder, PB; Raley, DM; Maximizing the laboratory setting for testing devices and understanding statistical output in pulse oximetry. Anesthesia & Anesthesia. 2007 Dec;105(6Suppl):S85-94.
For more than three decades, we have served as the premier clinical testing and regulatory validation partner to the medical device, wearables, and consumer electronic industries. Our substantial expertise in the physiological monitoring space, in addition to fully equipped labs and network of associate hospitals, allows us to continually deliver best-in-class, complete solutions.
To learn more about pulse oximeter validation and our clinical validation wrap-around services, including human factors testing, contact us today.
- ISO 80601-2-61: Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- FDA Guidance Document - Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
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