PhysCade System

The PhysCade System is an AI-enabled medical decision support device that analyzes cardiac electrograms collected during electrophysiology procedures to assist clinicians in identifying regions of interest in the heart during atrial arrhythmias. It processes intracardiac electrical data and displays multipolar maps indicating the earliest site of activation and other activation characteristics to support clinical decision-making.

PhysCade uses USB flash drive data transfer (versus predicate's connector cable), is compatible with three data acquisition systems (predicate has two), analyzes early activation sites rather than dispersed electrograms, and accepts a broader range of catheter specifications (electrode sizes 0.5–3 mm, spacing 2–10 mm, 8–64 electrodes) compared to the predicate (1 mm electrodes, 2–3 mm spacing, fixed dipole counts). Both use color monitors, standard keyboards/mice, and proprietary software algorithms on off-the-shelf hardware.

IEC 62304 Edition 1.1 2015-06 was used for device development and testing. Referenced guidance documents include FDA's cybersecurity guidance, software premarket submission guidance, off-the-shelf software guidance, human factors/usability engineering guidance, and good machine learning practice guidance.

Both devices are programmable diagnostic computers (Class II, 21 CFR 870.1425, product code DQK) analyzing intra-cardiac atrial electrograms to generate multipolar maps supporting physician decision-making in atrial arrhythmia management. While PhysCade focuses on early activation sites versus the predicate's dispersed electrograms, and uses different connection methods and slightly broader catheter compatibility, these represent minor technological variations that do not raise new safety or effectiveness questions. The devices serve the same fundamental purpose using equivalent signal processing on digitized electrogram data from compatible acquisition systems.