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The CardioSTAT ECG Test Solution is intended to capture, and report symptomatic and/or continuous ECG information for long-term ambulatory monitoring (up to 14 days). It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms, such as palpitations, shortness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and thythm annotation. The report does not contain diagnostic interpretation; the report is provided for review to the intended user to render a diagnosis based on clinical judgment and experience.

The CardioSTAT® ECG Test Solution is a complete by prescription-only system for continuous ambulatory collection of ECG single-channel data for up to 14 days, followed by analysis and reporting of collected data. The CardioSTAT® ECG Test Solution is composed of two major components: (1) CardioSTAT® ECG Recorder and (2) ECG Analysis and Reporting Tool (EART) . The CardioSTAT® ECG Recorder (1) is a nonsterile, non-invasive, and single-patientuse recorder worn on the patient's torso that provides a continuous, single-channel, ECG recording for up to 14 days. The Recorder snaps onto two off-the-shelf FDAcleared long-term monitoring electrodes on which OFIX® adhesive tape is applied to ensure long-term adherence to the patient. After the prescribed recording duration, the device is taken off by the patient and mailed to the data analysis center for analysis where data is analyzed by Certified Cardiographic Technicians (CCT) using (2) ECG Analysis and Reporting Tool (EART). The EART is intended for use only by trained technicians. A clinical report is then sent to the physician. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the physician to render a diagnosis based on clinical judgment and experience. A home use kit (CardioSTAT® Home Application) is also offered which includes all required devices to allow for remote prescription and home application of the CardioSTAT® recorder. The included devices (surgical razor, alcohol prep pad, electrodes, OFIX® tape) outside of this submission are currently available on the market. The CardioSTAT® device is not designed to record ECG signals suitable to identify ST segment shifts and the EART software is not designed to detect or measure ST segment shifts. The ECG signal collected by the CardioSTAT® ECG Test Solution is not intended for automated analysis other than beat and noise detection. The ECG signal collected by the CardioSTAT® ECG Test Solution is not intended for third party ECG analysis systems. The CardioSTAT® recorder is not a real-time device and all clinical data is reviewed after the device has been returned to Icentia. The CardioSTAT® ECG Test Solution software provides automated detection of beats and noise only. All other classifications, rhythms and anomalies must be annotated by hand by the user in the EART software. Detections of beats and noise must be verified and confirmed by the user, or manually corrected with their respective annotation tools.