Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

The Thermoguide Therapy System is a neurosurgical laser device that uses a 1064 nm laser to necrotize or coagulate soft tissue through minimally invasive procedures under MRI guidance. It consists of a mobile laser unit, sterile single-use laser applicators with introducers, and a workstation with software that processes MRI images to calculate real-time tissue temperature maps and estimate thermal damage during the ablation procedure.

The subject device expands MRI compatibility from 3.0T only to both 1.5T and 3.0T field strengths (Siemens and GE scanners), while maintaining identical laser wavelength (1064 nm), output power specifications (up to 10 W), thermometry methodology (PRF shift analysis), thermal dose calculation (CEM43 algorithm), and software architecture (Thermoguide Workstation) as the primary predicate. All technological components and operating parameters remain the same between subject and predicate.

The device was tested for compliance with ISO, IEC, and FDA safety and performance standards including IEC 60825-1:2014 (laser safety), IEC 60601-2-22:2019 (medical electrical equipment), and functional safety, basic safety, essential performance, and effectiveness standards. Performance testing addressed interoperability with MRI scanners, thermometry algorithm accuracy via correlation to physical measurements, temperature map update rates and real-time behavior, and product specification compliance.

The primary predicate is substantially equivalent because the subject device uses identical technical components, operating parameters, and software as the predicate—the only change is expanded MRI field strength compatibility (1.5T added to existing 3.0T). Comparative testing in both 1.5T and 3.0T environments using identical protocols and acceptance criteria demonstrated equivalent safety and effectiveness. The secondary predicate (NeuroBlate System, also cleared for 1.5T and 3.0T) supports equivalence by demonstrating that a substantially similar device with the same thermometry methodology and identical indications is already cleared for both field strengths.