Disposable Radiofrequency Cannula

The Disposable Radiofrequency Cannula is a small hollow needle with insulation and an exposed sharp tip used to create heat lesions on nerves for pain management. It is inserted parallel to a targeted nerve, and a stylet is removed to allow an RF electrode to pass through and deliver radiofrequency energy to lesion the nerve. It is indicated for use in managing peripheral nervous system pain, including facet denervation and trigeminal rhizotomy, and is single-use only.

The subject device is a product family comprising three model types (Classic, Select, and SMK Cannulas) that differ in hub material, hub design, insulation material, shaft length, active tip length, and gauge size. The device consists of a stylet, stylet cap, hub, and needle shaft, and is provided sterile using ethylene oxide. The subject device and predicate devices have similar technological characteristics with no differences that raise new safety or effectiveness questions.

ISO 10993-1, 10993-5, 10993-10, 10993-11, 10993-12, 10993-18, 10993-23 (biocompatibility); IEC 60601-1, 60601-1-2, 60601-2-2 (EMC and electrical safety); ISO 7864, 9626, 80369-7, 6009 (performance); ISO 11135 (sterilization); ASTM F2825, D4169 (packaging and shelf-life).

Abbott determined substantial equivalence based on the subject device and predicate devices sharing the same intended use (lesioning neural tissue by directing RF energy to target nerves), similar technological characteristics, and results of comprehensive performance, biocompatibility, sterilization, and packaging testing that confirm all requirements are met. Clinical studies were not required because differences between the subject and predicate devices do not raise new types of safety and effectiveness questions.