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The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding svringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients indicated for enteral feeding. This product is single use for no longer than 24 hours. The Mucosal Impedance Measurement System is equipped with sensors designed to collect and display real time and continuous gastric reactance "XL" measurements. The device is not for use as a sole diagnostic screening tool and is restricted to prescription use in a hospital environment.

The Mucosal Impedance Measurement System senses passive electrical features of the gastric tissue that corelate to of epithelial integrity through a technique known as 'bioimpedance spectroscopy'. Bioimpedance spectroscopy measures the ability of tissue to conduct electricity (resistance) and the ability of tissue to store charged particles (reactance). The Florence monitor model ISMO 1.0 is an electronic device that delivers electrical current to a small region of the gastric tissue through the Athena Catheter; the device measures the resultant voltage, and then calculates and displays impedance information in numeric and graphic representations. More specifically, to measure the bioimpedance of the gastric mucosa impedance, the device delivers electric current through the Athena Catheter. The resulting voltage developed between the two inner electrodes is sensed, filtered, amplified, and then digitized by the electronic circuits of the monitor. Once the measured voltage from the gastric tissue has been digitized, a proprietary algorithm processes the information and calculates the impedance spectrum and the Central Reactance parameter (XL). The device displays the information as either a function of frequency or as a function of time.

The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.

The Diversatek Healthcare MiVu Esophageal Endo Cap is the candidate accessory device for use with the approved predicate Diversatek Healthcare's MiVu Mucosal Integrity Testing system (MiVu System). The MiVu Esophageal Endo Cap is a new patient-contacting accessory that will be used in place of the MiVu Balloon Probe already approved as part of the MiVu System. The MiVu Esophageal Endo Cap device consists of a patient contacting sensor tip that is installed over the working end of an endoscope. The tip is a flexible thermoplastic elastomeric tube with a single row of four (4) gold plated pads, providing three (3) impedance sensors evenly spaced along the length of the impedance sensors are mounted on a pivoting platform to promote even contact of all sensor pads with the tissue. A polyurethane conduit tube containing interconnecting wires connects the individual impedance sensor pads on the sensor tip to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Endo Cap Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.

The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.

The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.