Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

The Vasoview Hemopro 3 is an endoscopic vessel harvesting system for minimally invasive surgery, primarily used in coronary and peripheral artery bypass procedures. It cuts tissue and controls bleeding through heat-based coagulation using direct current heating elements in curved jaws, and enables blunt dissection of blood vessels, ducts, and surrounding structures under endoscopic visualization.

The device has the same intended use, operating principles, basic design, sterilization method, and sterile packaging as predicate devices. The only modification is a material change to the C-Ring component of the harvesting cannula. Both jaw designs include insulation protecting adjacent tissue, with three heating elements (two for cauterization, one for cutting) powered by direct current only, not radiofrequency.

Bench testing used ANSI/AAMI ES60601-1, ANSI/AAMI HE75, IEC 60601-1-2, IEC 60601-1-6, ISO 15223-1, ISO 20417, ISO 14971, ISO 17664-2, ISO 11137-3, and ASTM D4169-22. No clinical testing was conducted.

The C-Ring material change does not affect the device's core function because design verification and validation testing—including mechanical/thermal characterization, durability, and extreme-use cadaver testing—demonstrated that the modified component maintains equivalent performance. Since the modification raises no new safety or effectiveness questions and all other technological characteristics remain identical to the predicate, substantial equivalence is established.