STAR Apollo™ Mapping System

The STAR Apollo™ Mapping System is software that assists physicians in interpreting 3D anatomical and electrical maps of the human atria during atrial fibrillation procedures. It processes electrogram data exported from FDA-cleared cardiac mapping systems (CARTO 3, Ensite X, Ensite Precision) to identify Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA), displayed as visual overlays on cardiac geometry. The system is never directly connected to patients and provides supplementary information to guide further physician-directed mapping and examination.

Both the subject device (v1.8) and predicate (v1.6) are standalone signal-processing software systems that accept multipolar intracardiac electrogram data from compatible mapping catheters and generate identical graphical outputs (ESA and RPA visualizations with WaveTrail color maps). The v1.8 adds compatibility with the OPTRELL™ Mapping Catheter and CARTO™ 3 EP Navigation System V8.1, plus ethernet data transfer capability via LiveSync; both versions use fixed algorithms, run on Windows 11 laptops, and are air-gapped with no network connectivity.

IEC 62304:2015-06 Edition 1.1 (Medical Device Software - Software Life Cycle Processes), ISO 14971:2019 (Risk Management to Medical Devices), and FDA's Content of Premarket Submissions for Device Software Functions guidance.

The STAR Apollo v1.8 performs equivalent functions to the predicate v1.6: both analyze the same input data (multipolar atrial electrograms), employ fixed signal-processing algorithms based on electrophysiology principles, generate identical outputs (ESA/RPA maps and WaveTrail visualization), and have identical intended use and indications. Software design verification and validation testing, including physician use studies, demonstrated equivalent functional performance and map generation across both predicate and subject mapping systems and catheters. The minor technological differences (new catheter/system compatibility and ethernet data transfer) do not raise different safety or efficacy concerns.