Ascblue (8010)

The Ascblue 8010 is an electrosurgical generator for cutting and coagulation of tissue in general surgery procedures using both monopolar and bipolar modes. It operates by applying high-frequency radiofrequency current to biological tissue to achieve precise surgical cutting with effective hemostasis and minimized bleeding.

The 8010 and predicate 8070 share the same energy source, operating modes (monopolar cut, monopolar coagulation, bipolar), and waveforms (sinusoidal constant/modulated). Maximum output powers differ slightly (300 W vs. 320 W for monopolar cut; 120 W vs. 100 W for monopolar coagulation; 90 W vs. 240 W for bipolar), with differences in output voltage, crest factor, and operating frequency remaining within the normal performance range defined by IEC 60601-2-2 standards.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and FDA's "Electrosurgical Devices for General Surgery" Guidance (March 9, 2020). Testing included ESU output performance, mechanical and electrical safety of accessories, neutral electrode thermal performance, and tissue ex vivo studies.

The 8010 is substantially equivalent to the predicate 8070 because both devices share identical intended use (monopolar and bipolar electrosurgery for cutting and coagulation), the same energy source and operating modes, and comparable technological characteristics. The observed differences in output power, voltage, and crest factor fall within acceptable ranges defined by consensus standards and do not raise new safety or effectiveness questions.