(365 days)
The CARTO™ RMT EP Navigation System is intended to acquire real time catheter based cardiac electrophysiolgical maps in patients who are eligible for a conventional electrophysiological study. The CARTO™ RMT EP Navigation System is restricted for use by licensed medical practitioner who participated in a CARTO™ training course. There are no special contraindications when using the CARTO™ RMT EP Navigation System.
The intended use of the CARTO™ RMT mapping system is catheter-based atrial and ventricular mapping.
The CARTO XP RMT mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the Stereotaxis Magnetic Navigation System in real time on the display screen.
The CARTO™ RMT System is intended to support EP procedures in the presence of the high metallic environment created by the Stereotaxis Magnetic Navigation System, as well as in a regular EP lab.
The CARTO " RMT EP Navigation system is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
In the conventional procedure both the patient and the physician are exposed to ionizing radiation during the course of the procedure. The CARTO™ RMT mapping system enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the enhanced magnetic navigation capabilities of the Stereotaxis Magnetic Navigation System (remote catheter navigation). In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the exposure to dangerous ionizing radiation.
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, sample size for test or training sets, data provenance, ground truth establishment methods, or whether a multi-reader multi-case study was conducted for the CARTO™ RMT EP Navigation System. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on regulatory aspects and substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).