LOW PROFILE FEEDING SET ACCESSORY

K971757 · Applied Medical Technologies · KNT · Nov 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971757
• Device Name: LOW PROFILE FEEDING SET ACCESSORY
• Applicant: Applied Medical Technologies
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.

Device Story

Low Profile Feeding Set Accessories function as replacement components for Mic-Key Skin Level gastrostomy systems. Devices facilitate delivery of enteral nutrition and medications, and allow for gastric decompression. Used in clinical or home settings by patients or caregivers. Accessories connect to existing gastrostomy tubes to maintain feeding access. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical feeding accessory components designed for compatibility with Mic-Key Skin Level gastrostomy devices. Materials and dimensions configured for secure connection to existing low-profile feeding ports.

Indications for Use

Indicated for patients requiring enteral feeding, medication administration, or gastric decompression via a Mic-Key Skin Level gastrostomy device.

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.

Reference Devices

• Mic-Key Skin Level feeding system

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 1997

Mr. Thomas W. Parkinson Leader - Quality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128

Re: K971757

Low Profile Feeding Set Accessory Dated: August 13, 1997 Received: August 18, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 KNT

Dear Mr. Parkinson:

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, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 for devices under 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W.Liau Yu

Lillian 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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## SECTION - 1

## 1.5. - INDICATIONS FOR USE STATEMENT

The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.

Roker R. Satting
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971257

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use_

Applied Medical Technology, Inc. - 510(k) Submission Low Profile Feeding Set Accessory Section 1 - Page 1.15. - As amended August 13, 1997