Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745662
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2023-02-16
Brief Title:
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest NIHO17
Sponsor:
Nihon Kohden
Organization:
Nihon Kohden
Study Overview
Official Title:
Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine the accuracy of devices called pulse oximeters which measure blood oxygen by shining light through fingers ears or other skin without requiring blood sampling Study will be used with patients at rest
Detailed Description:
This study is intended to evaluate performance of a new design pulse oximeter test device manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file Specifically SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None