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510(k) Data Aggregation

    K Number
    K170002
    Device Name
    Medline Blood Collection Set
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2017-09-19

    (259 days)

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

    The Medline Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood collection or short term IV administration (up to 2 hours), under the direct supervision of a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) summary for the "Medline Blood Collection Set" does not contain information regarding detailed acceptance criteria for device performance, the specifics of a study conducted to prove these criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or whether MRMC or standalone studies were performed.

    The document is a letter from the FDA confirming substantial equivalence for the device based on a 510(k) submission, and an "Indications for Use" statement. It does not delve into the technical validation studies of the device's performance against specific metrics.

    Therefore, I cannot provide the requested table and study details based on the information given.

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