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510(k) Data Aggregation
K Number
K080168Device Name
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
Manufacturer
Date Cleared
2008-05-16
(114 days)
Product Code
Regulation Number
882.5550Why 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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