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510(k) Data Aggregation

    K Number
    K992347
    Device Name
    CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1999-10-08

    (86 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS

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

    The Super Torque MB Angiographic Catheter with radiopaque marker bands is intended to provide angiographic visualization and linear measurements of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

    Device Description

    The Cordis Super Torque MB Angiographic Catheter with radiopaque marker bands consists of a 5.0 F single lumen, braided catheter having a minimum of two and maximum of twenty radiopaque, gold-alloy, marker bands circumferentially mounted on the a non-braided catheter tip.

    The Super Torque MB Angiographic Cathete with radiopaque marker bands will be offered in catheter lengths ranging from 65 cm to 125 cm.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands. It asserts substantial equivalence to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text. The submission focuses on comparing the new device's design, materials, and intended use to existing, approved devices.

    The document indicates:

    1. Acceptance Criteria and Reported Device Performance: This information is not provided. The document states: "The Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is substantially equivalent to the predicate devices. The equivalence was confirmed through non-clinical tests and analyses." It does not specify performance-based acceptance criteria or actual performance data.

    2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study with a test set generating performance metrics is described. The "non-clinical tests and analyses" are not detailed in terms of sample size or provenance.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

    4. Adjudication method for the test set: Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

    7. The type of ground truth used: Not applicable, as detailed performance validation against a "ground truth" is not described for this type of 510(k) submission focused on substantial equivalence based on design and materials.

    8. The sample size for the training set: Not applicable.

    9. How the ground truth for the training set was established: Not applicable.

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