(26 days)
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to
The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
This document describes a 510(k) premarket notification for a medical device, the "Infant Feeding Tube." The submission seeks to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically the characteristics and performance of the predicate device. The "reported device performance" demonstrates that the new device meets or is equivalent to these characteristics.
| Attribute | Acceptance Criteria (Predicate ProMedic Infant Feeding Tube – K020005) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Indications for Use | ||
| To be placed into the stomach to permit the introduction of fluids as directed by the physician. Nasogastric or orogastric placement. | Yes | Yes |
| Intended for single patient use for a duration of |
§ 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.