MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE

K984310 · Moss Tubes, Inc. · KNT · Feb 24, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984310
• Device Name: MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
• Applicant: Moss Tubes, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.

Device Story

All-silicone gastrostomy tube designed for enteral feeding. Device inserted through abdominal stoma to deliver nutrients directly into stomach. Functions as replacement device for existing gastrostomy tubes. Used in clinical settings by healthcare professionals. Provides access for nutritional support; facilitates patient feeding.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of silicone. Gastrostomy tube form factor. Intended for enteral feeding.

Indications for Use

Indicated for patients requiring enteral nutrition delivered directly into the stomach via an abdominal stoma. Intended as a replacement 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K984310 Moss Tubes All Silicone Gastrostomy Tube

Dated: November 30, 1998 Received: December 2, 1998 Regulatory Class: II 21 CFR876.5980/Procode: 78 KNT

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

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 regult 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.

provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of

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 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,

J.J.J.

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

Image /page/0/Picture/15 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

FEB 2 4 1999

Dear Mr. Schlakman:

Moss Tubes, Inc. c/o Mr. Harry A. Schlakman Consultant to the Medical Device and Pharmaceutical Industries 304 Verona Avenue Elizabeth, NJ 07208

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Exhibit IU

## 510(k) NUMBER (IF KNOWN): ___ K 98 431 O

DEVICE NAME:

Moss Tubes, Inc. All Silicone Gastrostomy Tube

## INDICATIONS FOR USE:

Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.

(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) | <div> <span style="text-decoration: overline;">✓</span> </div> |
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OR

| Over-The-Counter-Use (Optional Format 1-2-96) | <div> <span style="text-decoration: overline;"></span> </div> |
|-----------------------------------------------|---------------------------------------------------------------|
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K984310 |
|---------------|---------|
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