STAR RF Ablation System

The STAR RF 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 6 months of chronic pain unresponsive to conservative care and who have Type 1 or Type 2 Modic changes visible on MRI imaging.

The subject device is a bipolar, high-frequency electrosurgical system with a MetaSTAR RF Generator (operating at 480 kHz, 3-10W output), SpineSTAR Ablation Instrument with articulated distal shaft, StabiliT Introducer, and PowerCURVE Navigational Osteotome. Key differences from predicate: larger shaft OD (3.0 mm vs 1.98 mm), user-articulated vs pre-curved design, single thermocouple at 5 mm from ablation zone center vs at center, faster temperature rise (0.2-2.9°C/sec vs 0.5-1°C/sec), and shorter ablation duration (18-178 sec vs 420-900 sec).

Device tested per ISO 10993 biocompatibility standards (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity), IEC 60601-1/1-2/2-2 electrical safety and EMC, ISO 11137/11135 sterilization validation, ASTM standards for shipping/aging/corrosion, and IEC 62304 software verification. Temperature accuracy and mechanical properties (insertion force, tensile strength, articulation, lifetime) also validated.

The subject device is substantially equivalent because it has identical indications for use, intended use, mechanism of action (bipolar RF energy delivery for basivertebral nerve ablation), and similar technological characteristics to the predicate Intracept System. Performance testing demonstrates that minor design differences—such as shaft dimensions, articulation capability, and ablation parameters—do not introduce new safety or effectiveness questions and meet all specifications for the intended clinical use.