CARTO™ 3 EP Navigation System V8.1

The CARTO™ 3 EP Navigation System V8.1 is a catheter-based cardiac mapping system that acquires and displays 3D anatomical and electroanatomical maps of the heart during electrophysiological procedures. It provides real-time information about the electrical activity of the heart and catheter location using magnetic sensor technology and Advanced Catheter Location (ACL) technology, and can be used on patients eligible for conventional electrophysiological procedures with no special contraindications.

The V8.1 version has identical hardware platform, intended use, fundamental scientific technology, and magnetic/ACL location mapping accuracy as the predicate V8.0. The differences are software enhancements: support for FARAWAVE catheter visualization with Tissue Proximity Indication, support for VARIPULSE catheter with TruPulse generator, SOUNDSTAR Crystal Ultrasound catheter compatibility, and minor enhancements to seven legacy feature modules including Complex Signal Identification, VISITAG Module Stability+, and CARTOSOUND variants.

Not stated in this summary.

Substantial equivalence is established through comprehensive verification and validation testing demonstrating that V8.1 meets identical accuracy specifications as V8.0, all new features and improvements function as designed, and regression testing confirms no degradation of legacy features. Animal testing under simulated clinical conditions confirmed expected functionality. The device maintains identical hardware, intended use, and core location-mapping technology as the predicate, with only software-level feature additions and enhancements that do not raise new safety or effectiveness questions.