Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

RFMagik is an RF electrosurgical device intended for use in dermatologic and general surgical procedures to perform electrocoagulation and hemostasis. It consists of a main control unit with an LCD screen, three interchangeable handpieces (RO, AGNES F RF, and AGNES B RF), disposable electrodes, and a foot switch, allowing operators to select and adjust modes, parameters, and power output.

The device operates at 1 MHz monopolar radiofrequency with maximum output power of 32W at 200 ohm impedance. Key differences from the predicate (RFMagik Lite) include: (1) expanded electrode options with slightly increased needle thickness (0.2–0.3 mm vs. 0.2–0.25 mm) and additional needle types (AN series); (2) inclusion of two AGNES RF handpieces versus one in the predicate; and (3) addition of a VVIP handpiece. All other specifications—frequency, power, sterilization method (EO gas), shelf life (3 years), and electrode materials—remain identical.

Biocompatibility per ISO 10993-1, 10993-5, 10993-10, and 10993-23; sterilization per ISO 11135, 11138-1, 11138-2, and 10993-7; packaging and shelf life per ISO 11607-1 and 11607-2; electrical safety per IEC 60601-1, 60601-1-2, and 60601-2-2; and ex vivo thermal testing per FDA's August 2014 Guidance for Electrosurgical Devices.

The device is substantially equivalent because it shares identical indications for use, mode of operation (monopolar RF), output frequency, maximum power, and fundamental technology with the predicate RFMagik Lite. Although the subject device adds handpiece options and electrode variants with marginally different needle geometries, these differences do not raise new safety or effectiveness questions; bench and ex vivo testing demonstrated safe operation within design specifications. The lower maximum power (32W vs. predicate 32W) and expanded electrode range represent engineering enhancements that do not alter the fundamental electrosurgical mechanism or risk profile.