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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.

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