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The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor®. The new EndoRotor® will be referred to as the "modified EndoRotor" in this 510(k) Summary. The overall device description remains unchanged since initial FDA clearance. Both the predicate and modified EndoRotor® are powered resection tools consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The design modifications to the EndoRotor® described in the current 510(k) premarket notification include enhancements to improve the ease of use of the console and catheter components as well as provide flexibility to the gastroenterologist.

The EndoRotor is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection).

The EndoRotor is a powered resection tool consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The catheter consists of an outer cylindrical cannula attached to a braided catheter and a second inner cylindrical cannula positioned inside the lumen of the outer cannula. The inner tube has blades cut into the distal end, which is oriented adjacent to the distal end of the outer tube. A torque coil, located inside the braid, is attached directly to the inner tube, and provides rotation to the cutting tool when actuated by a foot pedal controlled drive motor. The inner tube rotates relative to the outer tube along its longitudinal axis to simultaneously cut tissue at the distal end only when the user actuates suction aspirating tissue through the lumen. The specimen is collected by a micron filter that is positioned in the flow path (in the single use specimen trap) that is mounted in a dedicated slot on the console.