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510(k) Data Aggregation

    K Number
    K223766
    Device Name
    NUVISION™ NAV Ultrasound Catheter
    Manufacturer
    Biosense Webster, Inc.
    Date Cleared
    2023-02-16

    (63 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K223832,K223733,K201775,K112050
    Predicate For
    K241540
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

    Device Description

    The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances.

    AI/ML Overview

    I am sorry, but the provided text does not contain the specific information required to answer your request. The document describes a medical device (NUVISION™ NAV Ultrasound Catheter) and its substantial equivalence to predicate devices for FDA clearance. However, it does not include details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML development and validation.

    The document primarily focuses on:

    • Indications for Use
    • Device Description
    • Comparison to predicate devices (physical characteristics, intended use, technical specifications)
    • General performance testing categories (bench, biocompatibility, animal testing)

    Therefore, I cannot generate the requested table and information as it is not present in the provided text.

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