(153 days)
AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).
AMSure™ Enteral Delivery Pump Set with Spike
The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure™ Enteral Delivery Pump Set with Spike. This document confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.
This letter, typical for medical device regulatory approval, does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies. These details are usually found in the original 510(k) submission document, which is not provided here.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided document is a regulatory approval letter and not a technical study report.
§ 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.