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510(k) Data Aggregation

    K Number
    K140442
    Device Name
    MEDSOURCE SELECTABLE IV SET
    Manufacturer
    MEDSOURCE INTERNATIONAL, LLC.
    Date Cleared
    2014-04-22

    (60 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDSOURCE SELECTABLE IV SET

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

    The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "MedSource Selectable IV Set." This document confirms the device's substantial equivalence to legally marketed predicate devices.

    However, the letter does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered medical device. It is a regulatory clearance document for a physical medical product (an IV set), not a software or AI product.

    Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance") are typically associated with performance studies for AI/ML diagnostic or assistive technologies, which are not described in this document.

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