EVAC

The Phasor EVAC is a subdural evacuation system indicated for accessing and draining cranial subacute or chronic hematomas and hygromas to an external suction reservoir. It is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures to remove chronic or subacute subdural hematomas.

The EVAC system uses battery-powered drill technology (compared to the manual SEPS predicate), includes a bolt that screws into the skull with comparable inner diameter, connects via similar silicon tubing to a 100cc drain reservoir, and includes a side port for occlusion relief or additional aspiration without requiring needle puncture through tubing.

Not stated in this summary.

The EVAC device is substantially equivalent because it shares the same intended use, patient population, and classification as the predicates (subdural drainage system, Class II, JXG/HBE). Although EVAC uses battery-powered drilling versus manual operation in SEPS, and includes design refinements like a side port precluding tubing puncture, these differences do not negatively impact safety or effectiveness. Performance and design validation testing demonstrated the device performs equivalently to stated predicates, with all core technological elements (sterile single-use construction, skull bolt insertion, reservoir connection) being comparable or supported by documentation.