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510(k) Data Aggregation

    K Number
    K961499
    Device Name
    LAGUNA SOFTIP DIAGNOSTIC CATHETERS
    Manufacturer
    BOSTON SCIENTIFIC SCIMED, INC.
    Date Cleared
    1996-10-17

    (182 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LAGUNA" Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.

    Device Description

    The LAGUNA" diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7. FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.

    AI/ML Overview

    The provided 510(k) summary for the LAGUNA™ Softip® diagnostic catheter does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

    This document describes a traditional medical device (a diagnostic catheter) and its technological characteristics and equivalence to predicate devices through physical tests. It does not involve any AI/ML components, image analysis, or performance metrics like sensitivity, specificity, or AUC that would be associated with AI/ML device studies.

    Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is entirely absent from the provided text.

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