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DOBBHOFF™ Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feeding tubes include an external proximal access port for connection to enteral feeding sets and to oral tip, enteral syringes. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube and, if a stylet was in place during tube insertion, to assist with removal of the stylet. The stylet is made of specially designed metal wire which may be optionally utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the amount of tube inserted into the alimentary tract.

The provided text is a 510(k) summary for the DOBBHOFF™ Dual Port Feeding Tubes. It describes the device, its intended use, and its comparison to legally marketed predicate devices. Critically, it states:

"No clinical evaluations were performed or relied upon for a determination of substantial equivalence."

This means that the information needed to answer the user's request, which focuses on acceptance criteria and a study proving the device meets those criteria, is not present in the provided text. The device's clearance was based on nonclinical testing (EN1615:2000 for performance and ISO 10993-1:2009 for biocompatibility) and a demonstration of substantial equivalence to predicate devices, not on a clinical study with acceptance criteria for device performance.

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