NCT03630016

SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Owlet Baby Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.

Detailed description

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. The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation. The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2. It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population. The study was conducted in accordance to the code of federal regulations for non-significant risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)

Conditions

• Hypoxia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pulse oximetry with Owlet BabySat v1.0 sensor	A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry 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 with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors

Timeline

• Start date: 2017-12-13
• Primary completion: 2017-12-17
• Completion: 2017-12-17
• First posted: 2018-08-14
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study