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The BioNavigation System for Placement of Enteral Feeding Tubes is intended to be assure to and in action information of the tube tip as it moves through a patient during the tube placement procedure.

The BioNavigation System for Placement of Enteral Feeding Tubes is designed to aid in the placement of an enteral feeding tube by providing a clinician with real-time information as to the location and direction of the tube tip during the placement procedure. Commonly used anatomical external markers used in auscultation procedures allow the clinician to approximate the internal position of the tube tip. Final tube position is confirmed using standard institutional procedures (x-ray, aspiration, or auscultation). The system includes a sensor device permanently mounted inside a sensor stylet (MAPCath) and an electronic transmitter / receiver instrument (NAVIGATØR) that emits low level electromagnetic signals that are sensed by the sensor device in the tip of the stylet. Prior to initiation of the enteral feeding tube insertion procedure, the MAPCath sensor stylet is positioned inside the lumen of the enteral tube adjacent to the standard stylet supplied with the tube. The sensor in the tip of the stylet is positioned near the tip of the tube and the stylet is locked in place. As the instrument is moved in the proximity of the sensor the instrument measures the change in response of the sensor and determines the relationship between the position of the sensor and the position of the instrument . The instrument provides an audible and visual display indicating when the NAVIGATØR instrument is positioned directly over the tube tip and also provides an indication of the direction the tube tip is pointing.

The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.

The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).