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510(k) Data Aggregation

    K Number
    K080168
    Device Name
    SHUNTCHECK - CSF SHUNT FLOW DETECTOR
    Date Cleared
    2008-05-16

    (114 days)

    Product Code
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO DIAGNOSTIC DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ShuntCheck is an aid to the detection of flow in implanted cerebrospinal fluid (CSF) shunts. ShuntCheck cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.
    Device Description
    ShuntCheck is a non-invasive device which detects flow in a CSF shunt via transcutaneous thermal convection. The device consists of a single use disposable thermosensor array patch which is connected to a handheld "biodisplay" unit. The shunt is cooled transcutaneously by placing ice over the shunt cephalic to the thermosensor. The thermosensor array patch, which is placed on the skin over the shunt "downstream" of the ice, reads the change in skin temperature over the shunt as cooled fluid flows downstream and also at a nearby control location. Data is captured in the biodisplay unit. If the device detects a characteristic downstream transcutaneous temperature dip, the biodisplay reports "flow confirmed". If no temperature dip is detected, the unit reports "flow not confirmed"
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