OptaBlate Radiofrequency (RF) Generator System

The OptaBlate Radiofrequency (RF) Generator System is an electrosurgical device used for bone tumor ablation in surgical procedures. It is intended for palliative treatment of metastatic malignant lesions in vertebral bodies, coagulation and ablation of bone tissue to relieve pain from metastatic lesions, and ablation of benign bone tumors such as osteoid osteoma. The device uses flexible probes with microinfusers that enable a unipedicular (single-needle) approach for tumor access and ablation.

The subject device shares identical technological characteristics with the predicate: both use radiofrequency energy at 500 kHz, operate in bipolar mode, deliver a maximum system output of 30 W (7.5 W per channel), employ temperature-controlled feedback, and are operator-controlled via the OptaBlate RF Generator. The key modification is incorporation of OptaBlate Curve flexible probes (10mm, 15mm, 20mm sizes) with microinfusers, enabling a unipedicular approach compared to the predicate's bipedicular approach, though both target the same anatomical site (bone) via percutaneous access.

Testing was determined by relevant standards and FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (March 9, 2020). Specific tests included sterilization, biocompatibility, packaging, and electrical safety and EMC testing. The specific ISO, IEC, or ASTM standards are not individually enumerated in this summary.

The subject device is substantially equivalent because it maintains identical intended use, indications for use, energy type, operating principles, output specifications, and feedback mechanisms as the predicate device. Although the subject incorporates new flexible Curve probes enabling unipedicular access (versus the predicate's bipedicular approach), this architectural modification does not introduce new safety or effectiveness concerns—both approaches target bone tissue using the same RF energy parameters and fundamental ablation mechanism. Non-clinical testing (sterilization, biocompatibility, electrical safety) and design verification testing confirmed equivalent performance, and no new questions of safety or effectiveness were raised by the access approach change.