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510(k) Data Aggregation

    K Number
    K030002
    Device Name
    LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2003-01-27

    (25 days)

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

    LIFESHIELD PRIMARY IV SET CONV. PIN.
    CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.

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

    For administration of I.V. fluids from a container to a patient's vascular system. The safety feature of this device aids in the prevention of needlestick injuries.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The document is a 510(k) clearance letter from the FDA for an Intravascular Administration device (Lifeshield Primary IV Set Convertible Pin), dated January 27, 2003.

    It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must comply with. The letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
    • Information about MRMC studies or effect sizes of human reader improvement with AI assistance.
    • Information about standalone algorithm performance studies.
    • The type of ground truth used.
    • Sample size or ground truth establishment for a training set.

    Therefore, I cannot fulfill your request based on the provided input.

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