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510(k) Data Aggregation

    K Number
    K994240
    Device Name
    EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
    Manufacturer
    BIOTRONIK, INC.
    Date Cleared
    2000-04-13

    (119 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K981083,K843707,K910608,K980869
    Why did this record match?
    Reference Devices :

    K981083, K843707, K910608, K980869

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

    BIOTRONIK's ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.

    The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.

    Device Description

    Elox (EX xx-BP) is a straight, bipolar endocardial pacing lead utilizing an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal Iridium coating. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The lead contains two conductors composed of quadrifilar MP35N wire in coaxial configurations and is insulated with silicone tubing. A 3.2 mm IS-1 bipolar connector attaches the lead to the pulse generator. The Elox lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

    AI/ML Overview

    The provided text is a 510(k) summary for the Elox Active Fixation Endocardial Lead. It describes the device, its indications for use, and lists predicate devices. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or clinical study details (like MRMC studies) that would be needed to answer your questions.

    Therefore, I cannot generate the requested table and information based on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed report of performance studies.

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