SpydrBlade Flex Instrument (PRD-RG1-001)

The SpydrBlade Flex Instrument is a single-use, sterile endoscopic electrosurgical instrument for cutting and coagulating soft tissue in gastrointestinal procedures. It uses radiofrequency energy for cutting and microwave energy for coagulation, delivered through a bipolar antenna mechanism with an opening and closing jaw function. The device is used with the CROMA electrosurgical generator and is not intended for cardiac procedures.

The subject device has similar design to the predicate (handle, shaft, distal tip) and uses identical RF and MW energy delivery from the same generator. Key difference: the subject device is composed of the same materials as the predicate except for one material with direct patient contact; biocompatibility evaluation confirmed no new concerns. The bipolar antenna dimensions and technical characteristics are similar to the predicate, and jaw mechanism does not impact RF and MW energy delivery.

ISO 11135:2014 and AAMI TIR28:2016 for sterilization; ISO 10993-1:2009 for biocompatibility; IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6, and IEC 60601-2-18 for electrical safety and EMC; FDA guidance on software verification and validation for premarket submissions.

The subject device performs identical cutting and coagulation functions to the predicate using the same RF and MW energy principles delivered through the same generator and coaxial connector. Although the subject device lacks the predicate's fluid injection feature, this feature is not applicable to the subject device's intended use and is provided by standalone injection tools. Design, materials (except one biocompatible variant), and energy delivery mechanisms are substantially equivalent, with all nonclinical testing passing acceptance criteria, demonstrating substantial equivalence without raising safety or effectiveness concerns.