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510(k) Data Aggregation

    K Number
    K134044
    Device Name
    EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
    Manufacturer
    CARDIOTEK, B.V.
    Date Cleared
    2014-03-31

    (90 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K071348
    Predicate For
    K161245
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EP-Tracer System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    Device Description

    The EP-Tracer system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-Tracer is comprised of these major components, 1. EP-Tracer hardware - Amplifier/stimulator 2. EP-Tracer Software - Software pre-installed

    AI/ML Overview

    The provided text focuses on the 510(k) summary for the EP-Tracer system, primarily comparing its technological characteristics to a predicate device (Mennen Medical EMS-XL Cardiac Electrophysiology System) to demonstrate substantial equivalence.

    From the provided text, there is no detailed experimental study proving the device meets specific performance acceptance criteria beyond demonstrating substantial equivalence to a predicate device. The document outlines the technological characteristics of the new device and the predicate device, indicating that the EP-Tracer system aligns with the predicate's specifications or improves upon them.

    Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not explicitly described for this specific 510(k) submission. This is common for 510(k) clearances that rely heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from scratch.

    However, I can extract the available information about the device's technical specifications, which are implicitly its acceptance criteria based on its predicate.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the EP-Tracer system are inferred from its technological characteristics being "Same" or improved compared to the predicate device, Mennen Medical EMS-XL. No specific quantitative "acceptance criteria" are explicitly stated with corresponding "reported performance" against those criteria in a tabular format as if it were a direct test. Instead, the comparison demonstrates equivalency.

    Below is a table summarizing the technological characteristics that were compared between the EP-Tracer and its predicate, acting as the de facto "acceptance criteria" for substantial equivalence. The "Reported Device Performance" for the EP-Tracer is simply its measured characteristic as stated in the document.

    Device CharacteristicAcceptance Criteria (Predicate: Mennen EMS-XL)Reported Device Performance (EP-Tracer™)
    Environmental Specifications
    Temperature Operating0°C to +35°C+10°C to +30°C
    Temperature Transport/Storage-15°C to +50°C-29°C to -66°C
    Humidity Operating100 dBSame
    Input ImpedanceTypical 20 MΩSame
    Leakage Current Patient Source
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