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510(k) Data Aggregation

    K Number
    K120206
    Device Name
    MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
    Manufacturer
    MEDTRONIC MINIMED
    Date Cleared
    2012-03-29

    (66 days)

    Product Code
    LZG,MDS
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Paradigm Insulin Pump system is indicated for the continuous delivery of insulin, at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

    Device Description

    Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-512); Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-712); Medtronic MiniMed Paradigm Insulin Pumps (Model Nos. MMT-515, MMT-715)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Medtronic MiniMed Paradigm Insulin Pump System, outlining its substantial equivalence to predicate devices and general regulatory information. It does not include details on specific performance criteria or a study describing how those criteria were met.

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