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510(k) Data Aggregation

    K Number
    K090117
    Device Name
    AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
    Manufacturer
    AUTOSAFE-REFLEX INC.
    Date Cleared
    2009-09-29

    (251 days)

    Product Code
    FMI,FPA
    Regulation Number
    880.5570
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passine needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the AutoSafe-Reflex® Safety Huber Infusion Set. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria as would be found in a performance study report for a diagnostic AI device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval, not a detailed description of device performance and underlying studies that would typically include such data.

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