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The Endoflip System is indicated for use in a clinical setting to measure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip System comprises a measuring system and a single use catheter to provide programmed balloon distensions.

The EsoFLIP® ES-310 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. Note: The EsoFLIP® ES-310 balloon catheter is to be used only with the EndoFLIP® system.

The EsoFLIP® ES-310 catheter is a balloon dilation catheter. It is used by surgeons or gastroenterologists to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux, and radiation therapy. This indication for use is identical to the predicate EsoFLIP® ES-series (ES-320) predicate, K142000. The EsoFLIP® catheter connects to the EndoFLIP® imaging system in the same fashion as the predicate EsoFLIP® catheter, to display an image of the cross-sectional-areas (CSAs) of the dilation balloon, and to allow the balloon to be inflated using the EndoFLIP® syringe driver. In all cases the catheters are to only be used with the EndoFLIP® system.

The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: - To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters) - For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory. The addition of the supplemental accessory FLIP Topography module does not modify the predicate EndoFLIP® System or change the intended use of the device. This modification does not alter the fundamental scientific technology; the EndoFLIP® System algorithm or change the hardware and accessories associated with the EndoFLIP® System. FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician.

The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus. pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus. pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus. Other indications for use include: · To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters) · For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

The EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997. The proposed modifications to the EndoFLIP® system is to expand the anatomical locations to encompass the measurement of pressures and dimensions in the esophagus, pylorus, and anal sphincters.