NCT04285411

Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vital USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

Summary

Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019

Detailed description

An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-Significant Risk (NSR) investigational studies, following International Standards Organization (ISO) 14155:2011 as appropriate and the pulse oximetry guidelines of ISO 80601-2-61:2017 applicable sections, and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013). The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. A secondary goal was to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered. The Pulse Rate Accuracy Root Mean Square (Arms) performance of the VitalDetect™ pulse oximetry system, were expected to meet a specification of 3 bpm.

Conditions

• Arterial Disease

Interventions

Type	Name	Description
DEVICE	Accuracy of the VitalDetect™ pulse oximetry system	The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.

Timeline

• Start date: 2019-11-04
• Primary completion: 2019-11-05
• Completion: 2019-11-20
• First posted: 2020-02-26
• Last updated: 2020-06-02
• Results posted: 2020-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study