Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Condition: Arterial Disease
Study type: Interventional

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.
    

Intervention name(s): Accuracy of the VitalDetect™ pulse oximetry system
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: Testing was conducted under normal office environment conditions. The VitalDetect™ pulse oximetry was placed on the right index finger of all subjects to evaluate the SpO2 and pulse rate accuracy performance during steady state non-motion conditions. A Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws and the real time oxygen saturation status. The subject was in a reclined position and connected to a breathing circuit, for administering medical grade oxygen and nitrogen. The gas flow delivery was adjusted for subject comfort. Arterial blood samples were drawn during simultaneous data collection from the control pulse oximeter and the test oximeters. The blood was immediately analyzed by Reference CO-Oximetry providing functional SpO2 for the basis of the SpO2 accuracy comparison. The pulse rate for the VitalDetect™ was compared to Reference ECG Heart Rate collected during the study.
Masking: None (Open Label)
Primary purpose: Device Feasibility