Prizma Pulse Oximeter Evaluation

NCT03080688 | Completed FDA Device

• 1 other identifier: BYL20160415
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• Blood oxygen saturation

  Comparison of Measurements: Prizma Device versus Gold Standard

  2 days

Study Arms (1)

Prizma

Measurement of oxyhemoglobin saturation by OSM-3 oximeter and Prizma oxygen saturation measurement

Device: Prizma Oxygen Saturation Measurement

Interventions

Prizma Oxygen Saturation Measurement DEVICE

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).

Prizma

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• G Medical Innovations Ltd.: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 15, 2017
• Study Start: April 15, 2016
• Primary Completion: April 15, 2016
• Study Completion: April 16, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share