| K-number | K251234 |
| Device name | EnSite X EP System |
| Applicant | ABBOTT MEDICAL |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jul 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
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. It is indicated as a diagnostic tool for patients undergoing electrophysiology studies to provide information about heart electrical activity and catheter location during conventional EP procedures.
EnSite X v5.0 maintains the same fundamental scientific technology as the predicate (v3.1) for catheter positioning and cardiac mapping. New features include compatibility with ViewFlex X ICE Catheter Sensor Enabled, compatibility with Shenzhen Mindray ViewMate Multi Ultrasound System V2.0, and introduction of 2D ICE features. All risks from these additions were mitigated to acceptable levels.
IEC 62304:2015-06 Edition 1.1 (Medical Device Software Life Cycle Processes), IEC 60601-1-2:2020-09 Edition 4.1 (Electromagnetic disturbances), ISO 14971:2019 (Risk Management), and FDA Guidance for Software Contained in Medical Devices.
Subject and predicate devices share identical intended use and indications for use, operating via the same fundamental scientific technology for catheter positioning and cardiac mapping. Software revisions added new catheter and ultrasound system compatibilities and 2D ICE visualization features without changing the core diagnostic function or raising new safety/effectiveness questions. Design verification testing confirmed the modified system meets user requirements and is substantially equivalent to the predicate device.
View the full FDA submission: accessdata.fda.gov