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510(k) Data Aggregation

    K Number
    K060454
    Device Name
    TITAN GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2006-03-24

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K052347
    Why did this record match?
    Device Name :

    TITAN GUIDEWIRE

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

    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

    Device Description

    The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (Titan steerable guidewire). It does not describe a study involving an AI/ML device, nor does it present acceptance criteria or performance metrics in the way typically expected for such devices.

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

    Here's why the document does not contain the requested information:

    • Device Type: The document describes a physical medical device (guidewire), not an AI/ML system.
    • Study Type: The "qualification testing" mentioned refers to non-clinical tests (visual/tactile, dimensional, mechanical attributes) to demonstrate equivalence to a predicate device, not a clinical study to assess the performance of an AI/ML algorithm.
    • Ground Truth, Experts, Sample Sizes (for AI/ML): These concepts are not applicable to the type of device and testing described in the document.
    • Acceptance Criteria/Performance Metrics (for AI/ML): The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," but it does not specify what those criteria were in terms of performance metrics for an AI/ML system. It only generally refers to the device being comparable to currently marketed devices and supporting substantial equivalence.

    If you have a document describing an AI/ML device and its associated studies, I would be able to extract the requested information.

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