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510(k) Data Aggregation

    K Number
    K151398
    Device Name
    K-Pack II Needle - 29G x 5/16 Thin Wall
    Manufacturer
    TERUMO EUROPE N.V.
    Date Cleared
    2015-06-25

    (30 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K984576,K082820
    Why did this record match?
    Reference Devices :

    K984576,K082820

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

    The 29G x 5/16" Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices 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

    Acceptance Criteria and Device Performance Study for K-Pack II Needle - 29G x 5/16" Thin Wall

    This document describes the acceptance criteria and a summary of verification activities conducted for the K-Pack II Needle - 29G x 5/16" Thin Wall, as presented in the provided 510(k) summary. The study aims to demonstrate substantial equivalence to predicate devices (K-Pack II Needles (K984576) and 29G x 1/2" Thin Wall K-Pack II Needles (K082820)).

    1. Table of Acceptance Criteria and Reported Device Performance

    TESTACCEPTANCE CRITERIAREPORTED DEVICE PERFORMANCE
    1. Visual appearanceSilicon amount on cannula not visible as droplets.Complies
    2. Limits for acidity or alkalinity$\Delta$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.Complies
    3. Limits for extractable metalsThe extract solution of the 29G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma Pb, Sn, Zn, Fe \le 5 mg/l$, $Cd
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