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510(k) Data Aggregation

    K Number
    K250258

    Validate with FDA (Live)

    Device Name
    HeartBeam AIMIGo with 12-L ECG Synthesis Software System
    Manufacturer
    Heartbeam, Inc.
    Date Cleared
    2025-12-08

    (314 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    18 - 150
    Reference & Predicate Devices
    K231424,K982090
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231424

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

    HEARTBEAM AIMIGo SYSTEM:

    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.

    HEARTBEAM 12-L ECG SYNTHESIS SOFTWARE:

    The HeartBeam 12-L ECG Synthesis Software synthesizes a 12-L ECG from the HeartBeam AIMIGo 3-Leads (in three-directions) recording device, producing a visual 12-L ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-L ECG.

    The synthesized 12-L ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-L ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-L ECG. The 12-L ECG Synthesis Software is intended for adult use only.

    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 3-lead 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 AIMIGo™ System is 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.

    This submission includes a modification to the HeartBeam System involving the addition of a new software feature, the HeartBeam 12-L Synthesis Software. Like the HeartBeam AIMIGo system, the patient-activated recording of a 3-L ECG is obtained and the HeartBeam 12-L Synthesis Software can synthesize a 12-L ECG signal from the 3-lead ECG signal recorded from the HeartBeam AIMIGo Device of the cleared system. The synthesized 12-L ECG output signal is intended to be an adjunct set of ECG information that complements but does not replace a standard 12-L ECG, to aid in the manual assessment of non-life-threatening arrhythmias.

    The synthesized 12-L ECG signal has not been studied or evaluated for safe and effective use for other cardiac conditions outside of manual non-life-threatening arrhythmias and is contraindicated for the assessment of any urgent, serious, or life-threatening conditions or arrhythmias.

    The new software works with the HeartBeam system, which retains all functionalities and performance characteristics of the previously cleared system. No changes to the hardware, intended use, or fundamental technological characteristics were made to incorporate the new software. Additionally, the synthesis software works with the standard 12-L ECG system, the EDAN SE-1515 DX-12. The EDAN SE-1515 DX-12 systems provide a patient's compatible standard 12-L ECG signal, which is used as one of the inputs for the synthesis software to create the personalized transformation matrix for each patient.

    AI/ML Overview

    N/A

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