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510(k) Data Aggregation

    K Number
    K082935
    Device Name
    VISION WIRE CORONARY GUIDEWIRE
    Manufacturer
    BIOTRONIK, INC.
    Date Cleared
    2008-12-04

    (64 days)

    Product Code
    DQX,VIS
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K030019,K061453,K964272
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VisionWire coronary guide wire is intended for the following applications:

    • Its positioning in the coronary vascular system (probing coronary vessel anatomy)
    • Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:
      • Measuring the left ventricular threshold
      • Measuring the intracardiac signals
      • Temporary pacing of the left ventricle
    • As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus
    Device Description

    The VisionWire coronary guidewire is a transvenous wire with sensing and stimulation capabilities. The VisionWire is intended to be used to facilitate the positioning of left ventricular (LV) pacing leads, with compatible guidewire lumen, within the coronary venous system during the implantable pulse generator (IPG) or Implantable Cardioverter Defibillator (ICD) for Cardiac Resynchronization Therapy (CRT). The VisionWire is used as a guide to position the over-the-wire (OTW) lead, especially in angled or tortuous veins. Prior to lead positioning, the VisionWire can be used to perform comparative intraoperative measurements of various pacing sites within the coronary venous system. Thus the physician can identify an appropriate pacing site for a LV lead.
    The VisionWire coronary quidewire is a disposable medical device designed for single use only.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the BIOTRONIK VisionWire Coronary Guidewire. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot populate the requested table or answer the specific questions about the study design and results using only the provided text. The document focuses on regulatory submission details rather than detailed performance study outcomes.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report that details the device's performance in meeting specified acceptance criteria.

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