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510(k) Data Aggregation

    K Number
    K142946
    Device Name
    TIVA
    Manufacturer
    Velano Vascular, Inc.
    Date Cleared
    2015-01-08

    (90 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K081229
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velano Vascular, Inc.

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

    The TIVA™ device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or a syringe.

    Device Description

    The TIVATM device is a sterile, single use device. It is a needle-free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes 20 and 22 gauge.

    AI/ML Overview

    The provided text is a 510(k) summary for the TIVA™ blood specimen collection device. It describes the device, its intended use, and its substantial equivalence to a predicate device based on functional and performance requirements and a comparison of design specifications.

    However, the document does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or information regarding sample sizes for training/test sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    The section titled "Functional and Safety Testing" briefly mentions that "representative samples of the device underwent biocompatibility, sterilization, and mechanical testing in accordance with the following industry standards," but it does not provide the results of these tests or specific acceptance criteria for them.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on the study specifics as the input document does not contain this level of detail.

    In summary, the document states that functional and safety testing was performed according to industry standards, but it does not report the acceptance criteria or the specific performance results for the TIVA™ device.

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