EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

The EnSite X EP System is a catheter navigation and mapping system that displays the 3D position of electrophysiology catheters and visualizes cardiac electrical activity as waveform traces and 3D isopotential and isochronal maps during electrophysiology procedures. It is indicated as a diagnostic tool in patients for whom electrophysiology studies have been indicated.

The subject device adds a new software license feature called AutoMark Index to the predicate EnSite X v3.1 system. There were no changes to the hardware. Both devices use the same fundamental scientific technology to facilitate catheter position and orientation, as well as cardiac mapping and model creation based on patient anatomy.

IEC 62304:2015-06 Edition 1.1 (Medical Device Software - Software Life Cycle Processes), ISO 14971:2019 (Application of Risk Management to Medical Devices), and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The subject and predicate devices share identical intended use and indications for use, employing the same fundamental scientific principles for catheter positioning and cardiac mapping. The only modification is a software feature addition with no hardware changes. Design verification testing confirmed the new feature met acceptance criteria with all risks mitigated to acceptable levels, and no new safety or effectiveness questions were raised, demonstrating substantial equivalence.