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510(k) Data Aggregation

    K Number
    K202357
    Device Name
    Nutricare Clear-ISOSAF Nasogastric Feeding Tube
    Manufacturer
    Three Circles Consulting Limited
    Date Cleared
    2020-10-01

    (43 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nutricare Clear feeding tube is intented for insertion into the alimentary canal of pediatric subgroups; Newborn (Neonate), Infant, Child, Adolescent) through either the nasal or oral cavity for the purpose of supplying fluids, medication or nutrition, for up to 30 days.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the Nutricare Clear-ISOSAF Nasogastric Feeding Tube does not contain information about an AI/ML medical device, its acceptance criteria, or the study proving its performance.

    The document is a standard FDA clearance letter for a physical medical device (nasogastric feeding tube), outlining:

    • The device name and its intended use.
    • The regulatory classification and product code.
    • Confirmation of substantial equivalence to a predicate device.
    • General controls and other regulatory requirements applicable to the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.

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