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510(k) Data Aggregation

    K Number
    K113673
    Device Name
    MYSAFETY SYRINGE
    Manufacturer
    MEDICALCHAIN INTERNARTIONAL CORPORATION
    Date Cleared
    2012-08-03

    (234 days)

    Product Code
    FMF,MEG
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K111734
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MySafety Syringe for Insulin is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of insulin into the body.

    Device Description

    The MySafety Syringe for Insulin is a sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with attached needle, which is intended for the injection of U-100 insulin into a diabetic patient, while minimizing the potential for accidental injury and preventing syringe reuse.

    AI/ML Overview

    The provided document is a 510(k) summary for the MySafety® Syringe for Insulin. It focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized consensus standards for medical devices. It does not describe a study involving an AI algorithm or software device that processes data to inform a diagnosis or treatment.

    Therefore, I cannot extract information related to:

    • Acceptance criteria and reported device performance for an AI algorithm.
    • Sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set in the context of an AI study.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone performance of an algorithm.
    • Sample size and ground truth for a training set in an AI context.

    The document describes the performance summary for a physical medical device (syringe) by stating that it "have been designed and successfully tested to meet the applicable requirements outlined in the FDA Recognized Consensus Standards." These standards are primarily related to physical/mechanical properties, biocompatibility, sterilization, and packaging for syringes, not AI performance.

    The listed standards are:

    • ISO 6009
    • ISO 7864
    • ISO 7886-1
    • ISO 8537
    • ISO 9626
    • ISO 10993 series
    • ISO 11135-1
    • ISO 11607-1
    • USP 33: 2010 Pyrogen Test

    To reiterate, this document pertains to a physical insulin syringe with a safety feature, not an AI/software device.

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