(113 days)
The Moss Gastrostomy Tube is used for gastric and proximal duodenal decompression plus duodenal feeding in adult populations.
The Moss Nasal Tube is used for decompression and simultaneous feeding in adult populations.
The 18", triple-lumen, 18FR Moss Gastrostomy Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the gastric site with aspiration within the proximal duodenum. Multiple holes in the suction lumen are designed to prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon. Each device is individually packaged, and sterilized by Ethylene Oxide.
The 44", triple-lumen, 18FR Moss® Nasal Tube provides decompression while simultaneously feeding enterally. The suction channel supplements the aspiration within the distal esophagus and proximal duodenum. Multiple holes in the suction lumen prevent mucosal occlusion. The second bore delivers an elemental diet three inches farther downstream into the distal duodenum, utilizing an industry standard ENFit connector. Refluxing excess is automatically removed while still within the proximal duodenum. The third lumen inflates a gastric retention balloon at the esophagogastric junction. Each device is individually packaged, and sterilized by Ethylene Oxide.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (Moss Gastrostomy Tube and Moss Nasal Tube - Mark IV).
It primarily discusses:
- The FDA's decision of substantial equivalence to predicate devices.
- Regulatory information (e.g., product codes, classification, general controls).
- Device descriptions and intended uses.
- A limited device modification (change in ENFit connector and cap material from ABS to Nylon).
- Mention of compliance with design controls and design verification activities (e.g., ISO 80369-3 conformance, chemical/mechanical stress test, biocompatibility, sterilization, shelf life).
However, it does not include:
- A table of specific acceptance criteria (performance metrics with pass/fail thresholds).
- Detailed study results proving the device meets these criteria.
- Information on sample sizes for test or training sets.
- Data provenance (country, retrospective/prospective).
- Details about expert involvement (number, qualifications, adjudication methods).
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used or how it was established for training and testing.
Therefore, I cannot populate the table or answer the specific questions you posed based on the provided text. The document confirms that design verification activities were completed, and that the device meets the requirements for "substantial equivalence" based on these activities, but it does not detail the nature or results of those activities in the way your request specifies.
§ 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.