A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE

K971434 · Applied Medical Technologies · KNT · Aug 17, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K971434
• Device Name: A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
• Applicant: Applied Medical Technologies
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Aug 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.

Device Story

AMT G-Tube Balloon Replacement Gastrostomy Tube is a medical device used to deliver nutrition directly into the stomach. It is inserted through an established stoma in patients unable to consume food orally. The device features a balloon mechanism to secure the tube in place within the stomach. It is intended for use by healthcare professionals in clinical settings. The device facilitates enteral feeding, providing a direct route for nutritional support to improve patient health outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gastrostomy tube with balloon retention mechanism. Materials and specifications are consistent with standard medical-grade tubing and balloon components for enteral access. Device is intended for use in established stomas.

Indications for Use

Indicated for patients unable to consume nutrition by conventional means requiring direct gastric nutrition via an established 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | 7 1998

Mr. Gary Austin Leader - Ouality Assurance and Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128

Re: K971434

AMT G-Tube Balloon Replacement Gastrostomy Tube Dated: June 1, 1998 Received: June 3, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

Dear Mr. Austin:

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 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 (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

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Page 2 - Mr. Gary Austin

the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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. If 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 [phone]. Additionally, for questions on the promotion 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/dsma/dsmamain.html".

Sincerely yours,

Rober R. Itting/

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K971434

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Anthony/

Division of Reproductive, Abdominal, ENT, and Radiological Devices ( 4 510(k) Number ,

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

(Optional Format 1-2-

96)