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    K Number
    K110527
    Device Name
    K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
    Manufacturer
    TERUMO EUROPE N.V.
    Date Cleared
    2011-06-06

    (102 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K050106,K051865
    Why did this record match?
    Device Name :

    K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE

    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 as well as for injection in infusion lines.

    Device Description

    The 25G 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 provided document describes the K-Pack Surshield™ Needle, a hypodermic needle with a passive sharps protection feature. It includes a summary of verification activities and acceptance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document outlines acceptance criteria but does not explicitly state the reported device performance for each criterion in numerical or qualitative terms in the provided text. It only states that "All necessary verification and validation tests have been performed by testing the K-Pack Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm in accordance with EN ISO 7864 (1995) and ISO/FDIS 23908 (2010)." This implies that the device met all acceptance criteria, but the specific results are not detailed.

    TESTACCEPTANCE CRITERIAReported Device Performance (Implied)
    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.Met acceptance criteria (tests performed).
    2. Limits for acidity or alkalinityA pH for K-Pack Needles extract solution is within 1 unit of the control fluid.Met acceptance criteria (tests performed).
    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: Σ Pb, Sn, Zn, Fe ≤ 5 mg/l Cd
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