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510(k) Data Aggregation

    K Number
    K955772
    Device Name
    CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
    Manufacturer
    TTK BIOMED, LTD.
    Date Cleared
    1996-07-08

    (200 days)

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

    The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.

    Device Description

    The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864. Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use. The sterile disposable syringes are made with prolypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.

    AI/ML Overview

    This 510(k) summary describes a submission for Clinicare Sterile Disposable Syringes, Sterile Disposable Syringes With Needles, and Sterile Disposable Needles. It does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The document is a regulatory submission intended to demonstrate substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria. It focuses on:

    • General Information: Submitter and device names, classification.
    • Predicate Devices: Lists Becton, Dickinson & Company products.
    • Description of Device: States compliance with relevant ISO standards (ISO 7886, ISO 7864, ISO 594, ISO 9626, ISO 6009) and material composition (polypropylene, SS304 capillary tubes, natural rubber, polydimethyl silicone lubricant).
    • Intended Use: General purpose injections.
    • Technological Characteristics & Tests for Substantial Equivalence: States "None," implying the device is substantially equivalent to predicates without requiring new technological characteristics or specific performance tests for this particular submission type.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

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