Starlight Imaging Catheter

The Starlight Imaging Catheter is a single-use, sterile imaging catheter designed for coronary artery visualization during interventional procedures. It uses near-infrared light delivered via a rotating fiber-optic core to create cross-sectional images of coronary vessels measuring 2.0 to 5.2 mm in diameter, and is not intended for use in vessels with prior bypass procedures.

The subject device shares the same intended use, functionality, and operating principle as the predicate (K221257). Key differences include different materials on the monorail and optical window, and different outer and inner diameters on the shaft. These material and dimensional modifications do not introduce new worst-case scenarios or impact safety and effectiveness.

ISO 10993-1 for biocompatibility testing, including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, hemocompatibility assays, and surface morphology comparison. Well-established bench test methods and animal study protocols used for predicate devices were applied.

The Starlight Imaging Catheter is substantially equivalent because it employs identical technology, indications for use, and operating principles as the predicate device. Confirmatory testing using predicate device methodologies—including biocompatibility, bench testing (optical performance, deliverability, pullback, trackability, kink resistance, tensile strength), and animal studies—demonstrated the minor material and dimensional changes do not compromise safety or effectiveness.