Microwave Ablation Device

The Microwave Ablation Device is a generator that delivers microwave energy at 2450 MHz through a disposable antenna to ablate (thermally destroy) soft tissue. It consists of a generator, disposable temperature probe, foot switch, and software-controlled system. The device is indicated for coagulation and ablation of soft tissue and is not intended for cardiac use.

Key differences from the predicate include: single-channel design versus one-way ring; adjustable temperature monitoring range of 35–90°C versus fixed at 45°C; adjustable over-temperature protection range; continuous-only output mode versus continuous/pulse/foot mode in the predicate; and slightly wider frequency tolerance (±50 MHz versus ±25 MHz). Max power is 50–80W versus 60–70W in the predicate.

IEC 60601-1:2005 and amendments (electrical safety); IEC 60601-1-2:2014+AMD1:2020/EN 60601-1-2:2015+A1:2021 (electromagnetic compatibility); IEC 60601-2-6:2012 and amendments (performance); ISO 10993-1:2018 (biocompatibility); FDA Guidance on Electrosurgical Devices for General Surgery.

The proposed device has the same indications for use, similar design features, and comparable technological characteristics as the predicate device (K232240). The differences in temperature monitoring, output modes, and power specifications do not raise new safety or effectiveness questions. Performance testing data demonstrates safety and effectiveness equivalent to the predicate device.