(30 days)
The MIC-KEY Low Profile Gastrostomy Tube is designed as a replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would benefit the patient.
Gastrostomy tubes are indicated for patients with inability to swallow, other neurological disorders, and other conditions for which tube feeding would benefit the patient in the judgment of the physician.
MIC-KEY® Low Profile Gastrostomy Tube
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "MIC-KEY® Low Profile Gastrostomy Tube." This letter approves the device based on its substantial equivalence to a legally marketed predicate device.
It is important to understand that this document describes a regulatory approval process based on equivalence, not a study performing specific acceptance criteria for a novel AI/software device. This document does not contain information about:
- Acceptance criteria in the context of device performance metrics (like sensitivity, specificity, AUC).
- A study proving the device meets acceptance criteria in the way an AI/software device would.
- Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for performance evaluation.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fill out the requested table and provide the detailed information about a "study that proves the device meets the acceptance criteria" because this document does not contain that type of information. It's a regulatory approval notice for a physical medical device.
§ 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.