Volta AF-Xplorer II

The Volta AF-Xplorer II is a cardiac mapping system that uses machine learning and signal processing to assist electrophysiologists in real-time annotation of 3D anatomical and electrical maps of the human heart. It identifies regions exhibiting spatiotemporal dispersion of electrograms during atrial fibrillation or atrial tachycardia procedures, helping operators locate areas of interest for ablation.

The device supports updated catheter compatibility (Advisor HD Grid X replaces Advisor HD Grid; Lasso 20 remains the only compatible 20-pole catheter). The operating system was upgraded to Ubuntu 22.04LTS from 20.04LTS. Output categories were simplified from separate orange/red (high/very high likelihood) to unified red (high likelihood) with added dispersion stability analysis. The algorithm architecture was modernized with state-of-the-art classifiers and expanded training dataset, though the methodology remains unchanged. Unidirectional digital communication was added with the MacLab CardioLab EP Recording System.

Not stated in this summary.

The Volta AF-Xplorer II maintains the same intended use, indications, regulatory classification, product code, and fundamental principles of operation as its predicate (Volta AF-Xplorer K243812). Both are signal processing-based atrial mapping systems with identical inputs (multipolar intracardiac signals) and similar outputs (dispersion detection). Changes in catheter compatibility, output visualization, algorithm implementation, and operating system do not affect safety or performance—bench testing confirmed autotagging functionality and dispersion detection perform at equivalent levels, and unitary testing achieved 100% conformity. These modifications represent refinements rather than new risks, addressing only technical improvements already validated by predicate clearance.