Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter is an intravascular imaging device designed to provide high-resolution, real-time images of coronary arteries using fiber-optic near-infrared light technology. It is indicated for use in coronary arteries during transluminal interventional procedures in vessels 1.3 to 6.0 mm in diameter, and may be used before or after intervention, but not in vessels with prior bypass grafts.

The device incorporates materials changes and minor design modifications to the catheter, converts packaging from a sealed-lid tray to a clamshell tray format, changes sterilization method from e-beam to gamma irradiation, and resolves software anomalies in the console. The intended use and indications for use remain unchanged from the predicate device.

ISO 10993-1 for biocompatibility evaluation; ISO 11137-1 and ISO 11137-2 for sterilization validation; FDA Class II Special Controls Guidance for PTCA catheters (2010) for particulate and coating integrity; 21 CFR Part 58 for Good Laboratory Practice in animal testing.

Substantial equivalence is demonstrated because the device maintains identical intended use and indications for use as the predicate (K242239), performs the same basic function of OCT intravascular imaging, and all modifications (materials, design, packaging, sterilization method, software) are characterized as minor changes. Comprehensive biocompatibility, sterilization validation, and animal study testing all met applicable acceptance criteria, confirming the modified design maintains safety and performance parity with the predicate.