OptiMap Catheter - 60mm (OPTI-CATH2-60)

The OptiMap Catheter is a sterile, single-use cardiac electrophysiology device with an expandable basket containing 64 electrodes (8 splines × 8 electrodes each) for detecting electrical potentials from the heart's endocardial surface. It is indicated to assist in diagnosing arrhythmias difficult to identify with conventional linear mapping catheters and can also deliver external pacing stimuli for use with a 3-D mapping system.

The subject device (OPTI-CATH2-60) differs from the predicate (OPTI-CATH2-50) only in basket size: 60mm versus 50mm. Both share identical intended use, principles of operation, 3-D basket-shape design with 8 radially spaced splines, same materials, same working length, same electrical ratings, same insertion method via 8.5 F sheath, and same pacing parameters.

Not stated in this summary. The document references ISO 13485 clauses for design controls, nonconforming product, corrective action, and preventive action in the regulatory requirements section, but no specific consensus standards are cited in the performance testing section.

The subject and predicate devices share the same intended use, indications, and underlying technological characteristics as basket-shape mapping catheters for intracardiac electrophysiology. The only difference—basket size (60mm vs. 50mm)—does not affect overall device performance or fundamental scientific technology. Performance testing including design verification, design validation, usability evaluation, animal testing, biocompatibility, sterilization, and electrical safety all met acceptance criteria with no new safety or effectiveness questions raised.