MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

K043027 · Applied Medical Technology, Inc. · KNT · Dec 2, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K043027
• Device Name: MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
• Applicant: Applied Medical Technology, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 2, 2004
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monarch™ G-Tube is to be used as a percutaneous replacement gastrostomy tube for use through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Monarch TM G-Tube can also deliver medication and allow for decompression of the stomach.

Device Story

Capsule Monarch™ is a percutaneous replacement gastrostomy tube. Device inserted through established stoma in patients unable to consume nutrition orally. Functions to deliver enteral nutrition, administer medication, and provide gastric decompression. Used in clinical settings by healthcare providers. Mechanical design facilitates replacement of existing gastrostomy tubes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous gastrostomy tube. Form factor designed for replacement through established stoma. Materials and construction consistent with standard gastrointestinal tube requirements under 21 CFR 876.5980.

Indications for Use

Indicated for patients with an established gastrostomy tract/stoma who are unable to consume nutrition by conventional means. Used for enteral nutrition delivery, medication administration, and gastric decompression.

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)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2004

Mr. Derek Williams Engineering Manager/Project Lead Engineer Applied Medical Technology, Inc. 15653 Neo Parkway CLEVELAND OH 44128-3150

Re: K043027

Trade/Device Name: Capsule Monarch™, Transshaping Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: October 29, 2004 Received: November 3, 2004

Dear Mr. Williams:

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). You may, therefore, market the device, subject to the general controls 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 (PMA), it may be subject to 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.

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Page 2 - Mr. Derek Williams

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 (21 CFR Part 807); 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 requirements as bet ronic 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 prerieted 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

\$\$

Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal, and Radiological Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION - D

## b. - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Capsule Monarch™, Transshaping Gastrostomy Tube Trade Name: Frace Name:

Indications For Use (as shown in labeling):

The Monarch™ G-Tube is to be used as a percutaneous replacement gastrostomy tube for The Moharon - O-Fubo 15 to be assurostomy tract. This device will assist in providing a patient with a well established gas are through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Monarch TM G-Tube can also deliver medication and allow for decompression of the stomach.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David Simpson

(Division Sign-O Division of Reproductive. Abdo and Radiological Devices 510(k) Number ver-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

> Applied Medical Technology, Inc. -510(k) Submission Capsule Monarch Section D - Page D.2