physIQ Heart Rhythm and Respiratory Module
physIQ, IncThe physIQ Heart Rhythm and Respiration Module is a software device that analyzes ECG signals and movement data to calculate heart rate, heart rate variability, detect atrial fibrillation, and determine respiration rate. It helps clinicians remotely monitor cardiac and respiratory health in adult patients outside of critical care settings, enhancing patient care through advanced signal processing and automated analysis.
Intended Use
The physIQ Heart Rhythm and Respiration Module is intended for use by qualified medical professionals for calculation of heart rate and heart rate variability, detection of atrial fibrillation, and determination of respiration rate using ambulatory ECG and triaxial accelerometer data in adult patients for remote monitoring in subacute clinical and nonclinical settings.
Technology
The physIQ Heart Rhythm and Respiration Module is an all-software callable function library implemented in Python for automated analysis of single ECG channels and triaxial accelerometer data. It integrates with customer systems via API or middleware scripts to output vital signs such as heart rate, variability, atrial fibrillation detection, and respiration rate.
Performance
Performance testing included clinical and bench validation for heart rate, heart rate variability, atrial fibrillation detection following ANSI/AAMI EC57 guidelines, and respiration rate validation against acceptance criteria and predicate device performance, demonstrating comparable and adequate performance for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/30/2018
7 months - 2
FDA Approval
7/10/2019
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