LOBO Vascular Occlusion System

The LOBO Vascular Occlusion System is a single-use, sterile medical device designed to obstruct or reduce blood flow in peripheral arteries. It consists of a self-expanding nitinol mesh implant with radiopaque markers, connected to a pusher and handpiece, delivered through a catheter to the treatment site. The device is not indicated for use in areas subject to crush or bend forces, such as joint areas or superficial vasculature.

The subject device has the same or similar technological characteristics as the predicate devices, including identical intended use and principle of operation as a self-expanding nitinol mesh device. All fundamental design characteristics are present in either the primary or reference predicate, with any minor design differences between the primary predicate and subject device covered by the reference predicate.

Not stated in this summary. The document references ISO 13485 clauses for design controls, nonconforming product, corrective action, and preventative action in regulatory requirements, but does not cite specific consensus standards used in the device testing.

The LOBO Vascular Occlusion System is substantially equivalent because it shares identical indications for use, the same principle of operation, and comparable technological and performance characteristics with its predicates. Nonclinical performance verification testing including bench and GLP animal studies demonstrated successful device delivery, deployment, blood flow reduction, and no device-related migration or vessel damage, supporting substantial equivalence to the predicate device.