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510(k) Data Aggregation

    K Number
    K231424
    Device Name
    HeartBeam AIMIGo(TM) System
    Manufacturer
    HeartBeam, Inc.
    Date Cleared
    2024-12-13

    (576 days)

    Product Code
    MWJ,DPS,DXH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K173952,K210753
    Why did this record match?
    Device Name :

    HeartBeam AIMIGo(TM) System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

    Device Description

    The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only.

    The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

    • . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
    • Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

    Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter).

    The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

    The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

    AI/ML Overview

    The provided text addresses the clinical study, but lacks specific details on the acceptance criteria and the comprehensive study data. Based on the information available, here's a breakdown of what can be inferred and what is missing:

    The HeartBeam AIMIGo™ System Clinical Study Summary

    The HeartBeam AIMIGo™ System underwent two clinical studies to support its 510(k) submission, confirming its substantial equivalence to the predicate device (AliveCor KardiaMobile 6L) and a reference device (VectraCor Universal Smart ECG).

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. It indicates that "All study endpoints were met" for both clinical studies, implying that the device's performance reached the predefined success criteria. However, the specific metrics and targets are not detailed.

    Inferred Performance Goals (based on study objectives):

    • Pivotal Study: To demonstrate clinical equivalence of ECG waveforms between AIMIGo 3-L VECG and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias. This implies high level of agreement or correlation in ECG waveform morphology and characteristics relevant for arrhythmia detection.
    • Device Positioning Validation Study: To validate that within a predetermined range of distance, direction, and orientation from the recommended position, the AIMIGo 3L VECG output signal characteristics remain unaffected when compared to a simultaneously recorded standard 12L ECG signal, for interpretation of non-life-threatening arrhythmias. This suggests performance robustness under varied positioning.

    Observed Device Performance:

    • "All study endpoints were met" for both the Pivotal Study and the Device Positioning Validation Study. This is the only reported device performance.

    Table Structure (Hypothetical, as specific criteria are not provided):

    Acceptance Criteria CategorySpecific Metric/Endpoint (Hypothetical)Target (Hypothetical)Reported Device Performance
    Pivotal StudyECG Waveform Equivalence for Arrhythmia Interpretatione.g., >90% Agreement with 12L ECGAll endpoints met
    Specificity for Non-life-threatening Arrhythmiase.g., >X%All endpoints met
    Sensitivity for Non-life-threatening Arrhythmiase.g., >Y%All endpoints met
    Positioning StudySignal Quality Robustness Across Positioninge.g.,
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