(87 days)
The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this product line.
The intended uses and components of the of Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System.
The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 106.
The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyetherbased polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French.
This document is a 510(k) summary for a medical device called the "Kangaroo® EntriStar Jejunal Feeding System." It is a submission to the FDA (Food and Drug Administration) for premarket notification.
However, the provided text does not contain any information about acceptance criteria, study data, sample sizes, expert ground truth, or any of the other specific details requested in your prompt.
The document only asserts substantial equivalence to a predicate device (BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube/System) based on:
- Identical intended uses and components.
- Identical technological and performance characteristics.
- The only change being the manufacturing site.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details, or ground truth information because that data is not present in the provided text.
This document is a regulatory submission focused on demonstrating equivalence rather than presenting an clinical performance study. For such details, one would typically look for a separate clinical study report, a performance study report, or a section within the 510(k) that explicitly addresses performance testing against defined acceptance criteria.
§ 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.