OneRF Trigeminal Nerve Radiofrequency Probes

The NeuroOne OneRF Trigeminal Nerve Radiofrequency (TN-RF) Probe is a radiofrequency ablation device designed to create lesions in trigeminal nerve tissue for treatment of facial pain and functional neurosurgical procedures. The probe is connected to a radiofrequency generator and uses thermal energy to destroy targeted nerve tissue through operator-controlled ablation.

The subject device features a single open-lumen probe (closed at tip) with 0.8 mm diameter and 5–8 electrode contacts, compared to the primary predicate's single closed-lumen probe with 1 contact. Temperature measurement occurs via an accessory inserted into the probe lumen (matching the secondary predicate sEEG-RF), not embedded in the tip. The probe uses polyimide electrodes with platinum contacts and is compatible with the cleared OneRF Generator.

ISO 14971 (risk management), ISO 11135 (ethylene oxide sterilization with SAL 10⁻⁶), ISO 11607-1 (package integrity), ISTA 3A, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88 (packaging and distribution testing), FDA guidance on Human Factors and Usability Engineering (February 3, 2016).

The subject device shares identical intended use and indications (RF lesioning for pain treatment and functional neurosurgery) with the primary predicate (Cosman TEW RF Probe). Although the subject probe has multiple contacts and an external temperature sensor (differing from the primary predicate's single contact and embedded sensor), these differences are not novel: the subject probe's design is identical to the already-cleared secondary predicate (sEEG-RF Probe, K231675). Non-clinical testing demonstrated lesion sizes proportional to time and temperature, comparable to predicate performance, and all mechanical, sterilization, and usability validation testing passed. Since the probe design, mechanism of action (thermal cellular necrosis), and performance characteristics are established via an already-cleared device, and new accessories (cannula, Tuohy Borst adapter) are conventional components with validated dimensional and mechanical properties, no new safety or effectiveness questions arise.