ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

“ECG-AI PH 12-Lead algorithm interprets 12-lead ECG voltage time series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds or longer duration of a single 12-lead ECG acquisition, and within seconds detects the presence of pulmonary hypertension in the intended patient population. The software module can be integrated into a client application to be accessed by clinicians and results viewed through an Electronic Medical Record (EMR) system or an ECG Management System (EMS) ECG-AI PH 12-Lead algorithm is provided as a software module packaged in a Docker container to facilitate installation.”

“ECG-AI PH 12-Lead algorithm interprets 12-lead ECG voltage time series data using an artificial intelligence-based algorithm. Principal of Operation Machine learning-based algorithm”

“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). This device has been cleared by the U.S. Food and Drug Administration (FDA) with a Predetermined Change Control Plan (PCCP). As part of this authorization, the device software may be updated periodically to enhance performance, including for higher sensitivity and/or specificity.”

“The performance characteristics for the ECG-AI PH 12-Lead Algorithm have been evaluated with the following non-clinical testing: software verification and validation (per IEC 62304), cybersecurity, labeling verification and validation, and human factors. Compliant with FDA Guidance on Cybersecurity”