CARTO™ 3 EP Navigation System V9.0 with PIU Plus

The CARTO™ 3 EP Navigation System V9.0 is a catheter-based cardiac mapping system that acquires and displays three-dimensional 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, for use in patients eligible for conventional EP procedures.

The V9.0 version maintains identical intended use, fundamental scientific technology, magnetic and ACL location mapping technology, and location accuracy as the predicate CARTO™ 3 V8.1. The primary difference is the addition of an improved Patient Interface Unit (PIU Plus) and supporting software modifications; all other hardware components remain unchanged.

IEC 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances – Requirements), and IEC 60601-1-6 (Usability). Testing included proof of design, functional verification, unit tests, electrical safety and electromagnetic compatibility testing, and animal testing under simulated clinical conditions.

The CARTO™ 3 V9.0 is substantially equivalent to the CARTO™ 3 V8.1 predicate device because it has identical indications for use, the same technological characteristics and scientific principles, an unchanged hardware platform with only an improved Patient Interface Unit, identical location mapping technology and accuracy, and verification and validation testing demonstrating that modifications did not adversely affect existing features or raise new safety or effectiveness concerns.