(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.
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SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
InnerDyne, Inc. Submitter: 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 Estab. Reg. No: 1721520
Date Prepared: 15 March 1997
- Rick Gaykowski Contact: Vice President, Regulatory Affairs and Quality Assurance
- Sherwood Medical Company Sponsor: 1915 Olive Street St. Louis, MO 63103 Estab. Reg. No.: 1924954
Classification Name: Gastrointestinal Tube & Accessories Generic Name: Gastrostomy Tube & Accessories Trade Name: Sherwood Medical Company, Kangaroo®, EntriStar®, "Percutaneous Gastrostomy Kit"
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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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JUN 1 3 1997
Sherwood Medical Company % Mr. Rick Gaykowski Corporate Vice President, Regulatory Affairs --------------------------------------------------------------------and Quality Assurance InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 货971230 Re:
Sherwood Medical Company, Kangaroo®, EntriStar®, "Percutaneous Gastrostomy Kit" Dated: March 31, 1997 Received: April 2, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 KNT
Dear Mr. Gaykowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act You may, therefore, market the device, subject to the general controls (Act) . . provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 300 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMF) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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Page 2 - Mr. Rick Gaykowski
for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. । ਇ you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K977123 O
Sherwood Medical Company, Kangaroo®, EntriStar®, Device Name: "Percutaneous Gastrostomy Kit"
Indications for Use: The Sherwood Medicat Company; Kangaroo®, EntriStar®; "Percutaneous Gastrostomy Kit" is a medical device for the percutaneous placement of a long-term enteral feeding tube.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
参
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Carlyn Y. Neuland for R. Casting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number
InnerDyne, Inc. Kangaroo®, EntriStar® Gastrostomy Kit Premarket Notification
§ 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.