LIBERTY Endovascular Robotic System (LIBERTYOS)

The LIBERTY Endovascular Robotic System is a single-use, sterile, disposable device that enables physicians to remotely deliver and manipulate guidewires, catheters, and guide catheters to navigate to targets in the peripheral vasculature. The physician controls the system wirelessly from a handheld remote controller while seated away from X-ray radiation, reducing radiation exposure during peripheral endovascular procedures.

The LIBERTY system features a motorized bedside robotic drive, a wireless handheld remote controller (Bluetooth), and a mechanical articulated mounting arm. Compared to the Magellan predicate, LIBERTY has a more compact, portable, single-use design with wireless control instead of a wired console. Both systems use master-slave servo motor/encoder control to enable independent linear and rotational movement of guidewires and catheters.

Not stated in this summary. The document references V&V testing but does not cite specific ISO, IEC, ASTM, or other consensus standards.

LIBERTY is substantially equivalent to the Magellan predicate because both devices share the same regulatory class (Class II), product code (DXX), and core operational principle: remote manipulation of guidewires and catheters using motorized servo control in peripheral vascular interventions. Although LIBERTY differs in design (compact, single-use, wireless), these differences do not raise new safety or effectiveness questions because performance testing—including human factors validation, GLP-certified animal studies, and a clinical study showing 100% success rate with no serious adverse events—demonstrates equivalent safety and effectiveness profiles.