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510(k) Data Aggregation
K Number
K042728Device Name
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
Manufacturer
NOVUS MONITORING LTD
Date Cleared
2004-10-22
(21 days)
Product Code
GWM
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
NOVUS MONITORING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Camino Slim-Line™ Intracranial Monitoring System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
Device Description
The Camino Slim-Line™ system consists of a single-use 1.3mm diameter parenchymal and sub-dural catheter for the real-time measurement of intracran pressure (ICP) and an in-line cable monitor for the display of measured pressure. The Camino Slim-Line™ monitor can be connected to an external patient monitoring system to relay ICP measurements. ICP is monitored directly by a solid state sensor mounted on the side of the Camino Slim-Line™ ICP catheter close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use. The Camino Slim-Line™ monitor uses a small LCD display to show the measured ICP continuously in real time, both in digital form and as a real-time trace. The monitor can relay this measured information to an external patient monitoring system. In parenchymal applications, the Camino Slim-Line™ ICP catheter is used with an ing single-use Camino cranial access port or bolt, and an existing C ence procedure kit for cranial access. For Sub-dural applie eTM ICP catheter may be used with an existing tunneling trocar and convenience procedure kit for cranial access.
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K Number
K013930Device Name
NEUROSENSOR
Manufacturer
NOVUS MONITORING LTD
Date Cleared
2002-02-20
(84 days)
Product Code
GWM, DPW
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
NOVUS MONITORING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeuroSensor™ System is intended for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
Device Description
The NeuroSensor™ system consists of a single-use combined 2mm diameter parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables. CBF is measured using Laser Doppler flowmetry and provides real-time measurements of local blood flow in the brain. In the NeuroSensor™ system, low power laser light at 780nm is transmitted down a central fiber to the tip of the probe and illuminates the cerebral tissue. The laser light is scattered by the moving red blood cells and is collected by an array of collecting fibers at the tip of the probe. The reflected light is measured and the resulting signal processed to produce a measure of the perfusion or flux of blood in the local tissue sample volume. The flow measurement is converted into absolute units of ml/min/100g using an algorithm determined by a comparison between measurements made using the combined Laser Doppler probe and the reference method of Quantitative Autoradiography. ICP is monitored directly by a solid state sensor mounted on the side of the NeuroSensor™ probe close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use. The NeuroSensor™ monitor uses a color LCD display to show the two measured variables CBF and ICP continuously in real time, both in digital form and as a realtime trace. The monitor can accept measured arterial pressure from an external patient monitor, and can use this data and the measured CBF and ICP to derive cerebral perfusion pressure (CPP) and cerebrovascular resistance (CVR). Data is stored by the monitor and can be displayed as a trend graph over a period of 15 minutes, or 1,2,8 or 24 hours. Completing the system is a single-use cranial access port featuring a titanium alloy bolt, and a convenience procedure kit for cranial access.
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