Visualase V2 MRI-guided Laser Ablation System (9736422)

The Visualase V2 MRI-Guided Laser Ablation System is a neurosurgical device that uses a 980 nm laser with MRI-based thermal monitoring to ablate, necrotize, or coagulate intracranial brain tissue for treatment of brain tumors, radiation necrosis, and epileptic foci. It is intended for adults and pediatric patients age 2 years and older and combines a diode laser, coolant pump, workstation, and software that displays real-time tissue temperature changes during ablation procedures.

The V2 includes a single touchscreen compared to the predicate's dual screen, adds a light mast with laser mode indicators not present in the predicate, and increases temperature targets from up to 6 to up to 15 per MRI slice. Both systems use 980 nm lasers software-limited to 14.55 W, peristaltic pumps, and are compatible with 1.5T and 3.0T MRI scanners with identical thermal damage estimation and temperature default limits (85°C high, 43°C low).

IEC electrical safety and applicable horizontal standards verified through UL certification; software verification and validation and system verification performed per Medtronic 21 CFR 820.30 compliant Design Control procedures.

The V2 is substantially equivalent because it maintains identical intended use, laser wavelength, power output, thermal monitoring methodology, and MRI compatibility as the predicate Visualase system. The modifications (increased temperature targets, single touchscreen, light mast indicators, clarified pediatric indications) do not change the fundamental technology or risk profile, represent refinements in user interface and software capability rather than functional changes, and were verified through design controls to meet product requirements without altering intended use.