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510(k) Data Aggregation
K Number
K093787Device Name
IGUIDE CAPPA
Manufacturer
Date Cleared
2010-03-11
(92 days)
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
**CAS INNOVATIONS GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
iGuide CAPPA is intended to be an intraoperative image-guided computer-assisted navigation system for minimally invasive interventions for interventional radiology. iGuide CAPPA can be used combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-arm systems.
It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account.
The device is intended to be used in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.
Device Description
iGuide CAPPA is a navigation system that assists in the planning of different traiectories to selected targets and the navigated positioning of tools (e.g. biopsy needles, injection needles for vertebroplasty and kyphoplasty procedures) inside these targets. The navigation system can be used within the scope of interventional radiology.
Navigation System:
The navigation station consists of an industrial PC with an integrated touch-screen as user interface and specific navigation software. The PC is mounted on a mobile rack. For image acquisition the navigation system is connected to an imaging system (CT, MRT, C-Arm). A DICOM network application using the DICOM standard protocol provides the communication between the navigation system and the imaging system.
In order to track the navigation devices, an electromagnetic (EM) tracking system is used. This tracking system consists of a field generator producing an alternating electromagnetic field. The EM field induces voltage in the small coils implemented in the tips of the navigation devices. The voltage is measured by the EM tracking system and used to calculate the current position and orientation of the coil, thus determining the sensor's coordinates in five degrees of freedom (DoF).
The navigation hardware (PC, monitor, rack and tracking system) is combined to form NaviBase, a hardware and software platform for navigation applications.
Accessory Needles:
Electromagnetic needles with small coils embedded in their tips are used as navigation devices. For image-to-patient registration a reference plate (RP) is used. This plate makes it possible to map the patient image data to the actual physical data.
Motion Sensor:
Residual patient motion is monitored by an additionally tracked device (motion sensor) affixed to the patient's skin. The tracking system detects the motion sensor and sends its position relative to the RP to the navigation system. Patient motion is visualized on the monitor enabling the radiologist to recognize the motion and react accordingly.
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