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The NuVision ICE Catheter™ is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediativ patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. The catheter can be advanced, retracted and rotated within the anatomy. The catheter is comprised of a 10 Fr outer shaft capable of being rotated and deflected, which houses an ultrasound transducer. The outer shaft rotation is driven directly from a probe knob on the handle, while a deflection knob on the handle drives the deflection by controlling a deflectable inner shaft situated within the outer shaft. The imaging ultrasound transducer is a 2D piezo-electric array capable of real-time 3D imaging. The imaging field emanates perpendicular to the axis of one side of the imaging tip, also referred to as a probe. The tip movement, in combination with deflection of the distal catheter, provide the user with the ability to adjust the orientation of the imaging tip to visualize the target anatomy. An electrical connector proximal to the handle allows connection to the NuVision Connector Cable which also connects to an ultrasound cardiac imaging console. Printed circuit boards within the catheter system's electrical connectors help with signal distribution and conditioning. The NuVision ICE Catheter System relies on power from the ultrasound cardiac imaging console to function. The NuVision ICE Catheter is used with a compatible ultrasound cardiac imaging system with software cleared for market in accordance with 21 CFR 807.81(a)(3).