MEDLINE GASTROSTOMY TUBE

K073718 · Medline Industries, Inc. · KGC · Mar 19, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073718
• Device Name: MEDLINE GASTROSTOMY TUBE
• Applicant: Medline Industries, Inc.
• Product Code: KGC · Gastroenterology, Urology
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral formula and medications directly into the stomach.

Device Story

Medline Gastrostomy Tube is a percutaneous replacement device for enteral feeding. It is inserted into a well-healed, mature gastric stoma to facilitate the delivery of liquid enteral formula and medications directly into the stomach. The device is intended for use by healthcare professionals or trained caregivers in clinical or home settings. It functions as a conduit for nutritional support and medication administration, bypassing the oral cavity. By providing a direct route to the stomach, it ensures consistent delivery of nutrition and therapy for patients unable to ingest food orally.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous gastrostomy tube; silicone or similar biocompatible material construction; designed for placement in mature gastric stomas; non-powered, mechanical device.

Indications for Use

Indicated for patients requiring a percutaneous replacement tube for the delivery of liquid enteral formula and medications directly into the stomach via a well-healed, mature gastric stoma.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its head, representing the agency's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9

Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Inc. Enteral / OTC Division One Medline Place MÜNDELEIN IL 60060

K073718 Re:

> Trade/Device Name: Medline Gastrostomy Tube Regulation Number: 21 CFR \$876,5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KGC Dated: March 6, 2008 Received: March 13, 2008

Dear Mr. Clausen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|-----------------|-----------------------------------------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a series of numbers and letters in a stylized, handwritten font. The characters appear to be "K07318". The characters are bold and black, set against a white background.

## Indications for Use

510(k) Number (if known): K073718

Device Name: Medline Gastrostomy Tube

Indications for Use:

The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral formula and medications directly into the stomach.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Hulu Heumer

(Division Sign-Division of Reproductive, Abdomin and Radiological Devices

510(k) Number K073718