Prizma Pulse Oximeter Evaluation

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

Study Overview

• Status: Completed
• Conditions: Oxygen Deficiency
• Intervention / Treatment: Device: Prizma Oxygen Saturation Measurement

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 Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Selection of patients, both male and female, who meet the eligibility criteria (see below)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prizma; Measurement of oxyhemoglobin saturation by OSM-3 oximeter and Prizma oxygen saturation measurement	Device: Prizma Oxygen Saturation Measurement; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygen saturation	Comparison of Measurements: Prizma Device versus Gold Standard	2 days

Collaborators and Investigators

• Sponsor: G Medical Innovations Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): April 15, 2016
• Study Completion (Actual): April 16, 2016

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: BYL20160415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes