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    K Number
    K040899
    Device Name
    MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
    Manufacturer
    MEDEX, INC.
    Date Cleared
    2004-04-30

    (24 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

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

    The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:

    • in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
    • in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
    • in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
    • in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
    • inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.

    The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Medex, Incorporated regarding their Medex 3000 Series MRI Syringe Infusion Pump. This document does not include information about acceptance criteria or a study that proves the device meets those criteria.

    The letter confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the device.

    Therefore, I cannot provide the requested information based on the input text. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with/without AI assistance.
    6. Information about a standalone (algorithm only) performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.
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