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510(k) Data Aggregation

    K Number
    K152088
    Device Name
    IV-eye
    Manufacturer
    Date Cleared
    2016-02-24

    (212 days)

    Product Code
    Regulation Number
    880.6970
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novarix Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IV-eye is a hand-held, non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture. The IV-eye should only be used in conjunction with standard techniques of visualization and palpation in assessing and locating veins. The IV-eye is intended only for skin contact via a disposable single use cover.
    Device Description
    The IV-eye is a hand-held, battery powered electronic non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture. The IV-eye transmits near infrared light into a patient's tissue at a wavelength of 850nm. As the light hits a vascular structure it is absorbed by the hemoglobin in the blood, whereas it passes through other tissue. The camera in the device captures the light that has passed through the patient and, in identifying the blocked light and applying a number of algorithms, the IV-eye is able to produce an image on its LCD display of the patient's vascular structure directly underneath the device. This appears as a darker color to the contrasting tissue. The picture is updated in real-time and is close to actual size. Trained medical personnel can use the image of the patient's vascular structure to assist them in choosing a suitable vein for cannulation and venipuncture. The IV-eye is intended to be used only by trained medical personnel to assist them in locating suitable veins for venipuncture and cannulation. It does not differentiate between arteries and veins and should therefore only be used in conjunction with standard techniques of locating veins. Other than regular cleaning and replacement of batteries, the IV-eye requires no routine or preventative maintenance. The IV-eye includes a single-use cover which prevents the lower casing and wings of the device having direct contact with the patient, and is intended to reduce cross-contamination risk in using the device. The IV-eye is intended only for skin contact via this disposable single use cover.
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