(84 days)
Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.
Moss Tubes, Inc. All Silicone Gastrostomy Tube
The provided document is a 510(k) clearance letter from the FDA for the Moss Tubes All Silicone Gastrostomy Tube. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on novel performance studies with detailed acceptance criteria as one might find for a new, high-risk device or an AI/ML-based device.
Therefore, I cannot provide the requested table and information based solely on the text provided. The document confirms the device's clearance but does not elaborate on the specific studies and acceptance criteria that would typically be detailed for performance evaluation.
§ 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.