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510(k) Data Aggregation

    K Number
    K232647
    Device Name
    Microcatheter
    Manufacturer
    Surmodics. Inc.
    Date Cleared
    2023-09-29

    (29 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K173560
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

    Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

    Device Description

    The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.

    The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the distal end. The catheter is available in working lengths of 135 cm and 150 cm to facilitate access to various target sites.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a microcatheter, not an AI/ML device. Therefore, it does not contain any of the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.

    The document states:

    • The device is a "Microcatheter" (Trade/Device Name).
    • Its classification is "Percutaneous catheter" (Regulation Name, Class II, Product Code DQY).
    • It's a medical device for use in coronary and peripheral vasculatures.
    • "No clinical studies were required for the Surmodics Microcatheter." (Section 8.5)
    • Performance testing focused on "Coating Integrity (Particulate, Track Force), Simulated Use (part of track force testing), Pinch testing lubricity, and Biocompatibility." (Section 8.4)

    Since this document pertains to a physical medical device (microcatheter) and explicitly states no clinical studies were required, the questions regarding AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable and cannot be answered from this source.

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