Volta AF-Xplorer

The Volta AF-Xplorer is a machine learning and deep learning-based software system that assists operators in real-time annotation of 3D anatomical and electrical heart maps to identify atrial regions with dispersed electrograms (abnormal electrical signals exhibiting spatiotemporal dispersion) in patients with atrial fibrillation or atrial tachycardia. It works with standard EP catheters and compatible data acquisition systems to display analysis results on a computer monitor outside the sterile operating room.

The subject device is technologically identical to its predicate (K232616). Both devices have the same computing platform (Intel Core i7-7700 CPU, 32GB RAM, Debian-based Linux OS), the same input (intra-cardiac multipolar signals) and output (presence or absence of electrogram dispersion), the same compatible acquisition systems (LabSystem Pro, MacLab CardioLab, EnSite X), and identical hardware design including custom analog and ethernet cables. Both support manual annotation of dispersed areas and automatic tagging via bidirectional digital communication with the 3D mapping system.

Not stated in this summary.

The subject device is substantially equivalent to the predicate because it is technologically identical in design, materials, computing platform, software algorithm, inputs, outputs, and intended use. The only difference is removal of qualifying language from the indications for use statement regarding clinical significance; this change is supported by the Tailored-AF clinical trial on the VX1 device (the predicate's predecessor using the same primary algorithm), which demonstrated superior effectiveness of dispersed EGM ablation versus pulmonary vein isolation alone. Since the device functionality and principles of operation remain unchanged and the updated labeling reflects new clinical evidence without altering the device's role as an electrophysiological evaluation tool, it does not raise different questions about safety and effectiveness.