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THE NORTECH HYDROTOWER FLUID MANAGEMENT SYSTEMS SHALL BE USED FOR SUPPLYING FLUID FOR GENERAL ENDOSCOPIC PROCEDURES.

The Hydrotower ® Fluid Management System incorporates a peristaltic pump, motor, controller, power supply, and associated tubing and a sensor. The product allows continuous flow to an Endoscopic instrument by the constant refilling of a fluid "reservoir" bag. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the "reservoir" bag.

This document is a 510(k) premarket notification for the Hydrotower® Fluid Management System. It states that the device is substantially equivalent to legally marketed predicate devices and is intended for supplying fluid for general endoscopic procedures.

However, the provided text does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or any aspects of a clinical study or performance evaluation.

Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily an FDA clearance letter and a summary of safety and effectiveness, not a detailed performance study report.

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