OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

The OptaBlate BVN Intraosseous Nerve Ablation System is a radiofrequency ablation device designed to treat chronic low back pain by ablating basivertebral nerves in the L3-S1 vertebrae. It is intended for patients with at least six months of pain unresponsive to conservative care who have Type 1 or Type 2 Modic changes visible on MRI.

The subject device operates at 95°C with a ~0.27°/second temperature ramp and 7-minute RF duration, compared to the predicate's 85°C, 1°/second ramp, and 15-minute duration. It features a 1.75mm diameter stainless steel electrode with gold plating and includes saline infusion at 6 ml/hour via a Microinfuser, whereas the predicate uses a 2.0mm electrode without saline. Both use a 10mm active electrode length and Pebax insulation, and both are single-use percutaneous systems.

ISO 10993 series (cytotoxicity, irritation, acute systemic toxicity, sensitization), ISO 11135:2014 and ISO 11137 (sterilization), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, and IEC 60601-2-2 (electrical safety and EMC), plus ASTM D4169, ASTM F2096, ASTM F88 (packaging and mechanical testing).

Both devices share identical intended use, anatomical site, method of access, and mechanism of action (RF-induced thermal coagulation for basivertebral nerve ablation). The subject device's operational differences—higher temperature, faster ramp rate, shorter duration, and saline infusion—are designed to produce equivalent or superior lesions while maintaining safety; ex vivo lesion testing confirmed appropriate RF lesion formation. All biocompatibility, electrical safety, and performance testing passed, with no new safety or effectiveness concerns identified relative to the legally marketed predicate.