Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873947
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2021-04-30
Brief Title:
Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Sponsor:
Belun Technology Company Limited
Organization:
Belun Technology Company Limited
Study Overview
Official Title:
Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Status:
COMPLETED
Status Verified Date:
2021-04
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:
This study was a comparative single-center non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100 SaO2 under non-motion conditions Arterial blood sampling measured by functional SaO2 CO-Oximetry was used as the basis for comparison Testing was conducted under normal office environment conditions
Detailed Description:
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively In general pulse oximeters use two wavelength absorption spectrophotometry to measure oxygen saturation based on the amount of reflected or scattered radiation The wavelengths are selected to provide the best separation of absorbencies of oxy-hemoglobin O2Hb and deoxy-hemoglobin HHb states The ratio of the two absorbencies is used to calculate the oxygen saturation SpO2 value Because an arterial sample of blood is not required to make the measurement the pulse oximeter can provide non-invasive real time information The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing information to clinicians about patients oxygenation status
The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100 SaO2 to arterial blood samples assessed by CO-Oximetry for an SpO2 validation
The primary goal was to show the SpO2 accuracy performance for the investigational device below As a secondary goal the pulse rate accuracy performance for the Belun ring was calculated
It was expected that the Accuracy Root Mean Square ARMS performance would meet the required specification of ARMS 35 or lower in non-motion conditions for the range of 70 - 100 SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification For the pulse rate accuracy the desired goal was to have an accuracy performance of an ARMS of 3
No risks or adverse device effects were expected There were no contraindications for use in the proposed study study population
The study was conducted in accordance to the code of federal regulations for non-significant medical device studies and applicable ISO 14155 2nd edition 2011-02-01 applicable sections of ISO 80601-2-61 second edition 2017-12 Corrected version 2018-02 and Pulse Oximeters - Premarket Notifications Submissions 510ks Guidance For Industry and Food and Drug Administration Staff issued March 4 2013
The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100 SaO2 to arterial blood samples assessed by CO-Oximetry for an SpO2 validation
The primary goal was to show the SpO2 accuracy performance for the investigational device below As a secondary goal the pulse rate accuracy performance for the Belun ring was calculated
It was expected that the Accuracy Root Mean Square ARMS performance would meet the required specification of ARMS 35 or lower in non-motion conditions for the range of 70 - 100 SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification For the pulse rate accuracy the desired goal was to have an accuracy performance of an ARMS of 3
No risks or adverse device effects were expected There were no contraindications for use in the proposed study study population
The study was conducted in accordance to the code of federal regulations for non-significant medical device studies and applicable ISO 14155 2nd edition 2011-02-01 applicable sections of ISO 80601-2-61 second edition 2017-12 Corrected version 2018-02 and Pulse Oximeters - Premarket Notifications Submissions 510ks Guidance For Industry and Food and Drug Administration Staff issued March 4 2013
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?:
None
Is an FDA AA801 Violation?:
None