SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study

SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.

The study utilizes a single-site, physiology laboratory for non-randomized, prospective, interventional studies. The goal is to enroll a range of twelve (12) to sixteen (16) healthy adult volunteers. Subjects may be of any race,ranging in pigmentation from light to dark to meet the study design requirements. The general purpose of Invasive Controlled Desaturation Studies during motion is to validate the SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion conditions. This is achieved through paired observations of SpO2 and SaO2values over the specified SpO2 accuracy range of 70 % to 100 % SaO2 of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison. Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate.In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during motion conditions over a specified saturation range for the Oxysoft pulse oximetry system. The FDA Guidance Document for Pulse Oximeters and ISO 80601-2-61 define the accepted guideline for evaluation and documenting the SpO2 accuracy in humans. The OxySoft sensor is not FDA approved for the intended study population, healthy adults. To support the development of Nellcor pulse oximeter systems, data is required to test the performance of the sensors with pulse oximetry systems in the adult patient population. In order to accurately validate sensors, manipulation of oxygen and nitrogen levels through the administration of oxygen and nitrogen gas will occur. Measurements of SpO2and pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during motion and non-motion conditions will be taken and analyzed to support development of Nellcor technology and support FDA submission.