(279 days)
The Stomach (Gastric) Tube is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
All Silicone Stomach (Gastric) Tube (Model 2020)
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) clearance letter from the FDA for a device called "All Silicone Stomach (Gastric) Tube (Model 2020)".
This letter primarily focuses on:
- Device Name: All Silicone Stomach (Gastric) Tube (Model 2020)
- Regulatory Information: Regulation number, name, and class.
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Indications for Use: Gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
The document does not include details on:
- Acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- Ground truth establishment for the training set.
§ 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.