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510(k) Data Aggregation

    K Number
    K052893
    Device Name
    ATRICURE TRANSPOLAR SYSTEM
    Manufacturer
    ATRICURE, INC.
    Date Cleared
    2005-10-25

    (11 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K020919
    Why did this record match?
    Device Name :

    ATRICURE TRANSPOLAR SYSTEM

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

    The AtriCure Transpolar™ System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

    Device Description

    The AtriCure Transpolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (AtriCure Transpolar Clamp) intended for the ablation of soft tissues (for use by trained surgeons only) innonou for the and the and guide (Glidepath™ Tape). The Transpolar and an accessory of an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU).

    AI/ML Overview

    The provided text is a 510(k) summary for the AtriCure Transpolar System. It describes the device, its intended use, predicate devices, and manufacturing materials. However, it does not contain any information regarding acceptance criteria, device performance studies (like accuracy, sensitivity, specificity), ground truth establishment, sample sizes for training or test sets, or expert involvement for assessing performance.

    Therefore, I cannot provide the requested table and information as the source document does not contain this data. The document focuses on establishing substantial equivalence to a predicate device based on indications for use, basic overall function, and materials, rather than detailed performance metrics.

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