(62 days)
To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the "AMT Introducer: MINI Button Delivery System" does not contain information about acceptance criteria or a study that proves the device meets such criteria.
The 510(k) letter is primarily a regulatory document confirming that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. It focuses on:
- Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
- Regulatory Determination: Stating that the device is substantially equivalent, allowing it to be marketed.
- General Controls: Reminding the applicant of ongoing regulatory compliance requirements (annual registration, listing, good manufacturing practice, labeling, etc.).
- Indications for Use: What the device is intended to be used for.
There is no mention of:
- Specific performance metrics or acceptance criteria (e.g., accuracy, precision, reliability).
- Any study data, sample sizes, data provenance, ground truth establishment, or expert involvement.
- Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of information would typically be found in the more detailed technical sections of the 510(k) submission itself, which are not included in this letter.
§ 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.