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510(k) Data Aggregation

    K Number
    K042182
    Device Name
    Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
    Manufacturer
    ICU MEDICAL, INC.
    Date Cleared
    2004-09-01

    (21 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K080007
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ICU Needleless Connector is a single use , sterile, non pyrogenic Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the "Y Clave Connector Will Integrated Check Valve, Model XI-3432", an intravascular administration set.

    This document describes the regulatory approval of a physical medical device, not a software algorithm or AI model. Therefore, the information you're asking for, such as acceptance criteria, study details (sample sizes, ground truth, expert qualifications, etc.), MRMC studies, or standalone algorithm performance, is not contained within this regulatory letter. These types of details are typically found in the scientific studies or technical documentation submitted as part of the 510(k) application, but they are not summarized or presented in the clearance letter itself.

    To answer your request, I would need a description of a study or documentation related to an AI/algorithm-based medical device.

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