Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study
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|ClinicalTrials.gov Identifier: NCT03439306|
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment|
|Hypoxia||Device: Pulse Oximeter|
The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70 - 100% SaO2.
The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse oximetry systems at 1 second intervals.
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.
Multi-parameter monitor used during the study to observe a subject's vital signs including ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being delivered to the subject.
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||March 17, 2017|
|Actual Study Completion Date :||March 17, 2017|
healthy adult volunteer
Subject is 18 to 50 years of age.
Subject is a non-smoker or who has not smoked within 2 days prior to the study.
Device: Pulse Oximeter
The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.
- Collect SpO2 data for accuracy statistical analysis by 11 subjects [ Time Frame: 3 days ]Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 67-75. In general, 4 to 8 discrete points were collected at each of the levels.
- Accuracy data analysis [ Time Frame: 3 days ]Data analysis follows ISO80601-2-61:2011, Annex EE and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439306
|United States, Colorado|
|Louisville, Colorado, United States, 80027|
|Principal Investigator:||Arthur Ruiz Cabrera, M.D.||Clinimark, LLC|