NCT03439306

Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Belun Technology Company Limited · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions

Detailed description

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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-15
• Primary completion: 2017-03-17
• Completion: 2017-03-17
• First posted: 2018-02-20
• Last updated: 2018-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study