(63 days)
The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances.
I am sorry, but the provided text does not contain the specific information required to answer your request. The document describes a medical device (NUVISION™ NAV Ultrasound Catheter) and its substantial equivalence to predicate devices for FDA clearance. However, it does not include details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML development and validation.
The document primarily focuses on:
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- Device Description
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§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).