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510(k) Data Aggregation

    K Number
    K972464
    Device Name
    VITALMIX PLUS EMPTY I.V. CONTAINER
    Manufacturer
    PACIFIC DEVICE, INC.
    Date Cleared
    1997-11-05

    (127 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITALMIX PLUS EMPTY I.V. CONTAINER

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

    The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications.

    Device Description

    VITALMIX PLUS I.V. Containers and Transfer Set Components

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Vitalmix Plus I.V. Containers and Transfer Set Components." This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The document primarily focuses on:

    • Confirming that the device is substantially equivalent to a legally marketed predicate device.
    • Stating that the manufacturer can market the device subject to general controls and existing regulations.
    • Providing contact information for regulatory inquiries.
    • Listing the intended use of the device: "The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications."

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, standalone performance, or training set details) from this document. This typically requires reviewing a more detailed submission or study report, which is not part of this FDA clearance letter.

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