(150 days)
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 provided document, "Navion Biomedical Corp. Premarket Notification Information", primarily describes a new medical device and seeks a substantial equivalent determination from the FDA. It details the device's purpose, operational mechanism, and comparison to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes for testing or training, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone studies.
The document is a Premarket Notification (510(k)) submission, which is typically a preliminary step for new devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed report of a clinical trial proving specific performance criteria.
Therefore, I cannot provide the requested information based on the given input. The document focuses on the description of the device and its intended use, not on specific performance metrics or the studies required to establish them.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.