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510(k) Data Aggregation

    K Number
    K142693
    Device Name
    ZywieAI Software Library
    Manufacturer
    Date Cleared
    2015-02-20

    (151 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zywie, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZywieAI Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAI Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring. Verification of the output from ZywieAI Software is the responsibility of a trained healthcare professional or physician. The ZywieAI Software Library is used for analyzing ECG data for adult patient population.
    Device Description
    The ZywieAI Software Library is an "object library". An object library is a collection of callable functions that have been compiled (or assembled) into machine code or Interactive Data Language (IDL) code for the computer on which they execute. The basic software application reads the input ECG signals from a file into computer memory and passes that data to ZywieAI Software Library for analyzing, annotating, and creating output. This output is sent back to the basic software application where the output is written to a file. The read input signal may invoke some or all of the functions in the object library. An application program could be written to write input data to a file using web services. The same or a different application program could be written to consume the output file using web services. The ZywieAI Software Library provides ECG signal processing, ORS Detection, Nonpaced Arrhythmia Interpretation, PAC, Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV Conduction Block, ST Change Episodes detection, Non-paced Ventricular Arrhythmia calls and rhythm interpretation. The library can be accessed through an Application Program Interface (API) as a callable function or using a web service call. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product. Zywie will compile the ZywieAI Software Library as specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer. who can then integrate it into application software for their ECG analysis.
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