(72 days)
The Sherwood Medicat Company; Kangaroo®, EntriStar®; "Percutaneous Gastrostomy Kit" is a medical device for the percutaneous placement of a long-term enteral feeding tube.
The Kangaroo®, EntriStar®, "Percutaneous Gastrostomy Kit" is a sterile, single use system containing a gastrostomy tube for enteral feeding and the components required to insert the tube percutaneously, which may include endoscopic and/or laparoscopic methodology. The kit consists of a radially expanding access device, gastrostomy tube, obturator, insertion/removal device, "Y" connector, luer adapter, external retention disk, retention band, #11 scalpel, drape, gauze pads, lubricant, and Instruction for Use (IFU).
The radially expanding access device is an expandable dilator sheath assembly with an access needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal tissue into the gastric cavity.
If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the gastrostomy tube.
This document is a 510(k) premarket notification for a medical device and does not contain a study describing acceptance criteria and device performance.
Instead, it's a submission to the FDA to demonstrate that the Sherwood Medical Company's "Percutaneous Gastrostomy Kit" is substantially equivalent to legally marketed predicate devices. The FDA's letter confirms this substantial equivalence.
Therefore, I cannot provide the requested information based on the provided text. There is no performance study, acceptance criteria, sample sizes, expert qualifications, or ground truth details within this regulatory document.
§ 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.