Vasoview Hemopro 3 Power Supply

The Vasoview Hemopro 3 Power Supply is a reusable, AC-powered device that converts AC power to DC current for use with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. It enables cutting and coagulation of vessels and tissue during minimally invasive vessel harvesting procedures, primarily for coronary artery bypass grafting and peripheral artery bypass. The device is positioned outside the sterile field and does not make direct contact with the patient.

The device has the same intended use, operating principles, and DC current output as its predicates (Starion Universal Power Supply and Vasoview Hemopro Power Supply components). The key modification is fixed DC energy output rather than variable output, but design verification testing demonstrates this difference does not raise new or different safety or effectiveness questions.

ISO 15223-1, ISO 20417, ISO 14971, ISO 17664-2, ASTM F2825-18, ASTM D4169-22, ANSI/AAMI HE75:2009, ANSI/AAMI ES60601-1:2005/A2:2021, IEC 60601-1-6:2010/AMD2:2020, and IEC 60601-1-2:2018 were used or referenced for electrical safety, EMC, human factors, labeling, cleaning, and packaging validation.

The device is substantially equivalent because it shares the same indications for use, operating principles, and DC current output as the predicate devices. Design verification and validation testing, including electrical safety, EMC, and human factors studies, demonstrated equivalent performance and no new safety or effectiveness issues. The modification of fixed versus variable DC output does not raise new or different safety concerns, as supported by the successful bench testing and usability validation.