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Acculis Accu2i pMTA Applicator with SulisVPMTA Generator software release 2.1.0 is indicated for the intraoperative coagulation of soft tissue.

The Acculis Accu2i pMTA (Mk2) Applicator is a surgically invasive, sterile single patient use device that delivers microwave energy for the purpose of the coagulation of soft tissue and represents modifications of the predicate generally to add an intermediate length and reduce system output power range. Based on the modifications within this submission the generator software will also include respective changes to control the output and add multi lingual capabilities. The Acculis MTA System as a whole includes the (1) Acculis Accu2i pMTA (Mk2) Applicator, (2) Sulis VMMA Generator with ver. 2.1.0 software, (3) Acculis Local Control Station and (4) optional MTA temperature probes. The Acculis Accu2i pMTA (Mk2) Applicator is a surgically invasive, sterile, single patient use device designed to deliver microwave energy for the purpose of the coagulation of soft tissue. The Acculis Accu2i pMTA (Mk2) Applicator is available in three lengths 14cm (standard); 19cm (intermediate) and 29cm (long). These lengths permit the user to select the appropriate length to reach the target tissue area. The Acculis Accu2i pMTA (Mk2) Applicator incorporates a bespoke connector which interfaces with the SulisVaMTA Generator via the Acculis pMTA Local Control Station (LCS). The LCS, used to control coolant flow to the applicator, is connected to the generator using a microwave coaxial cable and an integrated 12V power supply and data cable. The SulisVPMTA Generator is controlled via software version 2.1.0.

The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Acculis Accu2i pMTA Microwave Tissue Ablation Applicator