OptiMap Catheter - 50mm (OPTI-CATH2-50)

The OptiMap Catheter is a sterile, single-use cardiac electrophysiology device with an expandable basket containing 64 electrodes (8 splines with 8 electrodes each) that detects electrical potentials from the heart's inner surface. It is indicated for diagnosing complex arrhythmias that are difficult to identify with conventional linear mapping catheters and can also deliver external pacing stimuli.

The subject device shares the same fundamental basket-shaped mapping catheter design with 8 radially spaced splines, same working length, electrode spacing, and electrical ratings as the predicate. Differences exist in tip design and assembly, basket assembly, and circuit design and assembly, but these do not affect overall performance.

Not stated in this summary. The document references Design Verification Testing, Design Validation, Formative Usability Evaluation, Pre-clinical Animal Testing, Biocompatibility Testing, Sterilization Validation, Packaging Validation, and Electrical Safety Testing, but does not cite specific ISO, IEC, or ASTM standards.

The subject and predicate devices share identical intended use and indications for intracardiac electrophysiology mapping and pacing with similar underlying technological characteristics. The differences in tip design, basket assembly, and circuit design do not result in differences in overall device performance or fundamental scientific technology, making the subject device substantially equivalent to predicate K223666.