RF Cannula

The RF Cannula is a sterile, single-use medical device intended for use in radiofrequency heat lesion procedures to relieve pain. It consists of a stainless steel cannula with an insulating layer, stylet, hub, depth stop, and protection tube, and is used with a radiofrequency generator to create lesions in nerve tissue or perform percutaneous nerve blocks.

The subject device is composed of SUS 304 stainless steel, K-Resin, polyethylene, and polyethylene terephthalate. It is available in gauges 18G, 20G, and 22G, with lengths of 50mm, 100mm, and 150mm, and active tip lengths of 2mm, 5mm, and 10mm. It features straight bevel, curved bevel, and curved blunt tip options and is sterilized using ethylene oxide. The predicate device has similar gauges and lengths but includes a 200mm option and does not specify active tip lengths.

Testing used ISO standards including ISO 14971 (risk management), ISO 10993 series (biocompatibility and cytotoxicity), ISO 11135 and ISO 11138-1 (ethylene oxide sterilization), ISO 9626 (stainless steel needle tubing), ISO 7864 (hypodermic needles), ISO 80369-7 (small-bore connectors), IEC 60601-1 and IEC 60601-2-2 (electrical safety), ASTM F1980-16 (package aging), and ISO 11607 (packaging).

The device is substantially equivalent because it shares identical indications for use (RF heat lesion procedures for pain relief), identical performance characteristics and mechanics of operation (manual instrument), and identical sterilization method (ethylene oxide sterilization) as the predicate. The design, materials, and technological characteristics are substantially similar, with minor variations in available tip configurations and dimensions that do not affect fundamental safety or effectiveness. All non-clinical performance testing passed, demonstrating biocompatibility, proper sterilization, mechanical integrity, and electrical safety.