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510(k) Data Aggregation

    K Number
    K230934
    Device Name
    ViewFlex™ Eco Reprocessed ICE Catheter
    Manufacturer
    Abbott Medical
    Date Cleared
    2023-05-03

    (30 days)

    Product Code
    OWQ,OWO
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K223077,K222217
    Why did this record match?
    Reference Devices :

    K223077

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

    The ViewFlex™ Eco Reprocessed ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

    Device Description

    The ViewFlex™ Eco Reprocessed ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Eco Reprocessed ICE Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Eco Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.

    AI/ML Overview

    The provided text does not contain information about an AI/ML-driven device or study results proving a device meets acceptance criteria regarding AI/ML performance. The document is a 510(k) premarket notification for a medical device (ViewFlex™ Eco Reprocessed ICE Catheter) that appears to be entirely hardware-based, with no mention of AI or machine learning components.

    Therefore, I cannot provide the requested information about acceptance criteria and study results for an AI/ML device based on this document. The document primarily focuses on verifying the safety and effectiveness of a reprocessed catheter and its compatibility with an additional ultrasound console, through non-clinical testing (design validation and verification) and risk management.

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