(386 days)
The Nasogastric Bridle System with Maynetic Retrieval is intended to prevent inadvertent displacement or removel of nas sogastric to tubes from patients requiring naso enteric feed
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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on:
- Device Name: Nasogastric Bridle System with Magnetic Retrieval
- Applicant: Applied Medical Technology, Inc.
- Regulatory Information: 510(k) number (K030784), regulation number (21 CFR §876.5980), regulatory class (II), product code (78 KNT).
- FDA Determination: Substantial equivalence to a legally marketed predicate device.
- Indications for Use: To prevent inadvertent displacement or removal of nasogastric tubes from patients requiring naso-enteric feeding.
To answer your questions, I would need access to the 510(k) Premarket Notification submission itself, which would contain the performance data and study details.
§ 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.