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510(k) Data Aggregation

    K Number
    K073356
    Device Name
    PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
    Manufacturer
    MEDTRONIC MINIMED
    Date Cleared
    2008-04-25

    (148 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K030531,K031390,K040676
    Why did this record match?
    Device Name :

    PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715

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

    The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for an insulin infusion pump. It does not contain information on acceptance criteria, device performance, study details, ground truth, or sample sizes related to a medical device's performance in a study. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

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