Prizma Pulse Oximeter Evaluation

Completed

• Conditions: Oxygen Deficiency
• Interventions: Device: Prizma Oxygen Saturation Measurement

• Registration Number: NCT03080688
• Lead Sponsor: G Medical Innovations Ltd.

Brief Summary

This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically:

* SpO2 value range 70% to 100%

* 10 or more subjects, at least 3 of dark pigmentation

* At least 200 data points

* Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:

* 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:

* 4.1. ACCURACY OF PULSE OXIMETERS

* 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS

* ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2

* 201.12.1.101 SpO2 accuracy of pulse oximeter equipment

* 201.12.1.101.2 Determination of SpO2 accuracy

Detailed Description

The device under test was the Prizma which is a phone cover biometric device that includes reflectance oximetry. This device is a spot checker that requires the patient to hold their finger on the sensor during the measurement. The subjects were asked not to move during the study. In order to get consistent measurements the fingers were taped to the test device. The tape acted mainly as a reminder, and there were some problems with finger movement. A radial arterial cannula was placed in either the left or right wrist of each subject.

Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1). Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Oxyhemoglobin saturation was reduced to a series of targets and stabilized at the plateau value. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds. Two arterial blood samples were then obtained, approximately 30 seconds apart. A total of 24 samples were obtained per subject. Data were recorded by Bickler-Ye lab and provided for analysis.

Study Timeline

• Study Start: 2016-04-15
• Primary Completion: 2016-04-15
• Study Completion: 2016-04-16
• Study First Submitted: 2017-02-27
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-15
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Both male and female subjects
• Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below.
• Meeting the demographic requirements listed above.

Exclusion Criteria

• Smokers or individuals exposed to high levels of carbon monoxide that result in carboxyhemoglobin levels over 3% as tested by the BYL.
• Subjects who would be placed under medical risk under the desaturation profile listed below.
• Significant arrhythmia
• Age below 21 or over 50
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prizma	Prizma Oxygen Saturation Measurement	Measurement of oxyhemoglobin saturation by OSM-3 oximeter and Prizma oxygen saturation measurement

Primary Outcome Measures

Name	Time	Method
Blood oxygen saturation	2 days	Comparison of Measurements: Prizma Device versus Gold Standard