Valvuloplasty Balloon Catheter (ValvuloPro)

The ValvuloPro Valvuloplasty Balloon Catheter is a single-use, sterilized medical device indicated for balloon aortic valvuloplasty procedures. It consists of an inflatable balloon mounted on a coaxial catheter shaft with a 130 cm working length, a Y-shaped hub for balloon inflation and guidewire access, and radiopaque marker bands for fluoroscopic visualization during the procedure.

The subject device shares the same over-the-wire catheter design, balloon compliance characteristics, catheter materials, effective working length, and ethylene oxide sterilization method as the predicate device. It differs in offering expanded balloon size configurations and improved compatibility with standard commercially available guidewires and introducer sheath sizes, without changes to fundamental design or operating principles.

Testing was conducted in accordance with the FDA guidance document 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions' (April 14, 2023), applicable international standards, and internal test methods. Biocompatibility was evaluated per ISO 10993-1.

The subject device demonstrates substantial equivalence to the predicate device (K240967) because it shares identical intended use, materials, and core design principles, with differences limited to expanded size options and compatibility ranges. Non-clinical bench testing confirmed the device meets performance requirements without introducing new or increased risks, and no new patient-contacting materials or manufacturing changes were introduced.