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510(k) Data Aggregation

    K Number
    K111797
    Device Name
    27 G X 1/2 K-PACK SURSHIELD NEEDLE
    Manufacturer
    TERUMO EUROPE N.V.
    Date Cleared
    2011-09-22

    (90 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K110527
    Why did this record match?
    Device Name :

    27 G X 1/2 K-PACK SURSHIELD NEEDLE

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

    The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection.

    Device Description

    The 27G K-Pack Surshield™ Needle is a hypodermic single lumen needle, 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. Furthermore the needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. The K-Pack Surshield™ Needle is packed in a hard pack (cap - case) which is sealed with a perforated self-adhesive paper label.

    AI/ML Overview

    The manufacturer of the 27G x ½" K-Pack Surshield™ Needle established acceptance criteria and performed verification activities to prove its compliance.

    1. Table of Acceptance Criteria and Reported Device Performance (Summary of Verification Activities):

    TESTACCEPTANCE CRITERIAReported Device Performance*
    1. CleanlinessInspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 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.The device met the acceptance criteria. (Implied by the submission of the 510(k) and general statement "All necessary verification and validation tests have been performed..." - Specific numerical results are not provided in the document for each test).
    2. Limits for acidity or alkalinityA pH for K-Pack Needles extract solution is within 1 unit of the control fluid.The device met the acceptance criteria.
    3. Limits for extractable metalsThe extract solution of the K-Pack Surshield Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\sum$ Pb, Sn, Zn, Fe $\le$ 5 mg/l; Cd
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