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    K Number
    K150263
    Device Name
    K-Pack II Needle-21G x 2
    Manufacturer
    TERUMO EUROPE N.V.
    Date Cleared
    2015-04-01

    (56 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Special
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K984576,K001572
    Why did this record match?
    Device Name :

    K-Pack II Needle-21G x 2

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

    The 21G x 2" K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

    Device Description

    Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information provided in the document:

    Device: K-Pack II Needle - 21G x 2"
    General Type of Device: Hypodermic Single Lumen Needle

    Acceptance Criteria and Reported Device Performance

    TESTACCEPTANCE CRITERIAREPORTED DEVICE PERFORMANCE (Implied "Meets Criteria" since all tests were performed and the device was found substantially equivalent)
    1. CleanlinessInspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x2.5 magnification, the hub socket shall appear free from particles and extraneous matter.Meets Criteria
    2. Limits for acidity or alkalinity$\triangle$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.Meets Criteria
    3. Limits for extractable metalsThe extract solution of the 21G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma$ Pb, Sn, Zn, Fe ≤ 5 mg/l; Cd
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