(228 days)
The Sensei Robotic Catheter System, Artisan Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
The Hansen Medical Sensei Catheter Control, Artisan Catheter and accessories and are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, whilst enabling a physician to remain seated and away from the x-ray radiation source The Catheter Control System has been modified to display 3D electroanotomic maps from a 30 party mapping system in the center screen of the Sensei system.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Hansen Medical Sensei Catheter Control System, which describes the device, its intended use, comparison to predicate devices for substantial equivalence, and regulatory communication from the FDA. It does not include performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment details.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).