Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)

The Disposable Microwave Ablation Antenna is a single-use device used with a compatible Microwave Ablation Device to deliver microwave energy for coagulation and ablation of soft tissue. The device consists of an antenna, antenna shaft with temperature monitoring and cooling components, handle, and coaxial cable. It is not intended for cardiac use.

The proposed device offers expanded applicator lengths (100–1200 mm versus 80–180 mm), additional outer diameter options (1.4–2.2 mm versus 1.4–2.0 mm), different radiation pole exposed lengths (3, 5 mm versus 3.5, 10 mm), and adjusted maximum power (50, 80 W versus 60, 70 W). It uses PTFE, polyimide, and copper materials and operates at 2450 MHz ± 50 MHz compared to the predicate's ± 25 MHz tolerance.

IEC 60601-1:2005 and amendments (electrical safety), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), IEC 60601-2-6:2012 and amendments (performance), ISO 10993-1:2018 (biocompatibility), and FDA guidance on thermal effects testing for electrosurgical devices.

The proposed device has identical indications for use, the same intended purpose (soft tissue ablation), and similar operating principles to the predicate device. Differences in applicator dimensions and power parameters do not raise new safety or effectiveness concerns, and non-clinical performance testing demonstrates safety and effectiveness equivalent to the predicate device.