This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. Testing was conducted under normal office environment conditions.
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively. In general, pulse oximeters use two wavelength absorption spectrophotometry to measure oxygen saturation based on the amount of reflected or scattered radiation. The wavelengths are selected to provide the best separation of absorbencies of oxy-hemoglobin (O2Hb) and deoxy-hemoglobin (HHb) states. The ratio of the two absorbencies is used to calculate the oxygen saturation (SpO2) value. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information. The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling, and has helped to improve patient safety by providing information to clinicians about patients' oxygenation status. The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for an SpO2 validation. The primary goal, was to show the SpO2 accuracy performance for the investigational device below. As a secondary goal, the pulse rate accuracy performance for the Belun ring was calculated. It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3.5% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. For the pulse rate accuracy, the desired goal was to have an accuracy performance of an ARMS of 3. No risks or adverse device effects were expected. There were no contraindications for use in the proposed study / study population. The study was conducted in accordance to the code of federal regulations for non-significant medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO 80601-2-61, second edition 2017-12, Corrected version 2018-02, and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013).
Study Type
OBSERVATIONAL
Enrollment
10
The investigational device will be placed on the finger of the left or right hand per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
Clinimark, LLC
Louisville, Colorado, United States
Collect SpO2 data for accuracy statistical analysis by 10 subjects
Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The goal was to have an equal distribution of data by decade. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 70-75. In general, 4 to 8 discrete points were collected at each of the levels.
Time frame: 3 days
Accuracy data analysis
Data analysis follows ISO80601-2-61:2017, Annex EE and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013).
Time frame: 3 days
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