CARTO� 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc.The CARTO™ 3 EP Navigation System Software V8.0 is a catheter-based cardiac mapping system that helps clinicians map the electrical activity and anatomy of the heart in 3D during electrophysiological procedures. Using specialized catheters and advanced mapping technologies including machine learning algorithms, it improves visualization and identification of complex heart signals to guide interventions and improve procedural outcomes.
Intended Use
The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure, and it can be used on patients eligible for conventional electrophysiological procedures.
Technology
The CARTO™ 3 System uses specialized mapping catheters and reference devices to acquire catheter location and intracardiac ECG signals. It employs magnetic sensor technology and Advanced Catheter Location (ACL) technology for precise 3D mapping. It integrates machine learning algorithms like the Complex Signals Identification module for automatic tagging of fractionated signals and deep learning algorithms for automatic 3D segmentation of cardiac anatomy (CARTOSOUND™ FAM module).
Performance
The system underwent extensive verification and validation including software testing, bench usability testing, animal testing, retrospective validation on clinical data, and a Real-World Evidence clinical study demonstrating safety and effectiveness for catheter-based cardiac mapping procedures.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/27/2023
4 months - 2
FDA Approval
9/7/2023
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