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510(k) Data Aggregation

    K Number
    K991758
    Device Name
    MONOJECT INSULIN SYRINGE
    Manufacturer
    THE KENDAL CO.
    Date Cleared
    1999-06-14

    (21 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K851090,K922522,K955235,K980580
    Predicate For
    K033373,K081547,K160589
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.

    Device Description

    Monoject Insulin Syringes are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for Monoject Insulin Syringes. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include a study proving the device meets specific acceptance criteria. This type of regulatory submission typically focuses on demonstrating equivalence to existing legally marketed devices rather than presenting a performance study with detailed acceptance criteria.

    Therefore, I cannot provide the requested information as the document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Details of a study for the device.
    3. Sample size used for a test set or data provenance.
    4. Number of experts and their qualifications for ground truth establishment.
    5. Adjudication method for a test set.
    6. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
    7. Information on a standalone algorithm performance study.
    8. Type of ground truth used (expert consensus, pathology, outcome data).
    9. Sample size for a training set.
    10. How ground truth for a training set was established.

    The document primarily focuses on regulatory compliance, specifically the device's design, materials, and intended use being substantially equivalent to predicate devices, and its conformity to ISO 8537:1991(E) where applicable (with an exception for the new 30-gauge needle not covered by the standard).

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