OptiMap™ System

The OptiMap System is an electrophysiology mapping system that analyzes electrogram (EGM) signals from a 64-electrode basket catheter and displays the results in visual format to assist physicians in diagnosing complex cardiac arrhythmias. It is intended for use during electrophysiology procedures by trained medical professionals.

Both the subject device (OptiMap System) and predicate (Ablamap System) are Class II programmable diagnostic computers with identical indications for use, intended use, system components, compatible catheters, EGF recording parameters, and QRS detection thresholds. The subject device adds a new Activation Cycle Path (ACP) mapping feature and incorporates cybersecurity hardening per FDA guidance, neither of which were present in the predicate.

Not stated in this summary.

Substantial equivalence is established because: (1) both devices share the same regulatory classification, product code (DQK), and regulatory name (Programmable Diagnostic Computer under 21 CFR 870.1425); (2) they have identical indications and intended use with only device name differences; (3) all fundamental technological characteristics including system components, compatible catheters, and signal processing parameters are identical; (4) the new ACP feature and cybersecurity updates are software enhancements that do not alter hardware design, and verification/validation testing confirmed the device performs as designed and is suitable for its intended use; (5) no additional physical, electrical safety, or EMC testing was needed since hardware is unchanged.