Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

These are sterile, single-use bipolar electrosurgical applicators for otorhinolaryngeal (ENT) surgery. CelonProBreath reduces hypertrophic nasal turbinates in patients aged 2+; CelonProSleep plus treats snoring by shrinking and coagulating soft palate tissue in patients aged 18+. Both use radiofrequency-induced thermotherapy (RFITT) and connect to compatible electrosurgical generators.

Subject devices share bending angle, active length, diameter, cable length, maximum RF power output, gamma sterilization, and sterile packaging with predicates. New versions (WB990310, WB990311) add a 2-pin plug for the CELON ELITE ESG-200 generator with multiple modes and an RFID tag restricting certain coagulation modes, versus older 3-pin versions for LabENT. Sheath tube material changed within the same material group; gamma sterilization dose recalculated to 42 kGy per ISO 11137.

ISO 10993-1, 5, 10, 11 (biocompatibility); IEC 60601-1 and 60601-2-2 (electrical and thermal safety); IEC 60601-1-2 (EMC); ISO 11137-1 and -2 (sterilization validation); ISO 14971:2019 (risk management); IEC 62366-1:2015 and IEC 60601-1-6:2010 (usability).

Both device generations are mechanically and functionally identical to their predicates in critical design parameters (dimensions, power, sterilization). The new 2-pin connector and RFID tag merely enable compatibility with an updated generator (ESG-200) that supports multiple modes while restricting unsafe combinations through software—the fundamental ablation and coagulation mechanism remains unchanged. Bench testing confirmed comparable tissue effects at applicable power settings. The minor material substitution and sterilization dose adjustment are within established material groups and regulatory standards, demonstrating equivalent safety and performance.