COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)

K991668 · Novartis Nutrition Corp. · KNT · Jul 26, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991668
• Device Name: COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
• Applicant: Novartis Nutrition Corp.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the arternal retainer provided and suture, or another appropriate fixation technique.

Device Story

Surgically placed small bowel feeding access port; single patient use. Delivers enteral solutions and medications directly into small intestine. Placed and positioned in small bowel via appropriate technique; fixed to outer abdomen skin using provided retainer and suture or other fixation. Used in clinical settings by healthcare professionals. Benefits patient by providing reliable enteral nutrition and medication delivery route.

Clinical Evidence

bench testing only

Technological Characteristics

Solid radiopaque silicone construction; 50cm length; side and open-end exit ports; includes external retainer for fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring direct small bowel feeding access for delivery of enteral solutions and medications. Suitable for patients where direct access to the small bowel lumen is necessary.

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.

Predicate Devices

• Medical Innovations Corp. MIC Jejunostomy Tube #300-014 (K880767)

Submission Summary (Full Text)

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# U NOVARTIS

JUL 26 1999

## 510(k) SUMMARY

## COMPAT®JEJUNOSTOMY FEEDING TUBE KIT

SUBMITTER: Robert J. Lang Novartis Nutrition Corporation P.O. Box 370 Minneapolis, MN 55440 TEL: [phone] FAX: [phone]

CONTACT PERSON: Sharon Martin

DATE PREPARED: May 5, 1999

NAME OF DEVICE:

Novartis Nutrition COMPAT® Jejunostomy Tube Kit TRADE NAME:

Jejunostomy Tube Kit COMMON NAME:

CLASSIFICATION NAME: Gastrointestinal Tubes and Accessories (per 21CFR 876.5980)

PREDICATE DEVICE: Medical Innovations Corp. MIC Jejunostomy Tube #300-014 510(k) Number: K880767

#### DESCRIPTION: The Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use.

INTENDED USE: The device delivers enteral solutions and medications directly into the small intestine.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The COMPAT® Jejunostomy Tube Kit has the same intended use as the MIC Jejunostomy Tube. Principle differences include:

- . Length of 50cm compared to 30cm
- Solid radiopaque silicone compared to clear with stripe .
- Exit ports located at the side and open-end of tube ● compared to open-end only
- No "wings" or suture cuff compared to 2 soft "wings" and . a Dacron cuff

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Mr. Robert J. Lang Director of Quality Operations Novartis Nutrition Corporation 5320 West 23rd Street PO Box 370 Minneapolis, MN 55440

Re: K991668 COMPAT® Jejunostomy Tube Kit Dated: May 5, 1999 Received: May 14, 1999 Regulatory Class: II 21 CFR §876.5980/Procode 78 KNT

Dear Mr. Lang:

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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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) premarkel notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 Compiiance 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/dsmaldsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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K991668 510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

COMPAT Jejunostomy Tube Kit DEVICE NAME:

### INDICATIONS FOR USE:

The Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the arternal retainer provided and suture, or another appropriate fixation technique.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counter-Use (Optional Format 1-2-

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number .