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510(k) Data Aggregation

    K Number
    K132233
    Device Name
    K-PACK II NEEDLE - 27G X 3/4 THIN WALL
    Manufacturer
    TERUMO EUROPE N.V.
    Date Cleared
    2013-09-06

    (50 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K984576,K001572,K110850
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 27G x 3/4" Thin Wall 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

    The 27G x 3/4" Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the K-Pack II Needle - 27G x ¾" Thin Wall, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    The device passed all validation activities as indicated by the submission of the 510(k), which implies that the reported device performance met the specified acceptance criteria. The summary states: "All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995)."

    TESTACCEPTANCE CRITERIAReported Device Performance (Implied)
    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.Met Criteria
    2. Limits for acidity or alkalinityΔ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.Met Criteria
    3. Limits for extractable metalsThe extract solution of the 27G Thin Wall K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid:
    $Σ$ Pb, Sn, Zn, Fe ≤ 5 mg/l
    Cd
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