MOSS TUBES, INC. NASAL TUBE - MARK IV

K984629 · Moss Tubes, Inc. · BSS · Mar 2, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984629
• Device Name: MOSS TUBES, INC. NASAL TUBE - MARK IV
• Applicant: Moss Tubes, Inc.
• Product Code: BSS · Gastroenterology, Urology
• Decision Date: Mar 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for decompression and simultaneous internal feeding.

Device Story

The Moss Tubes, Inc. Nasal Tube - Mark IV is a medical device designed for nasogastric use. It facilitates simultaneous gastric decompression and internal feeding. The device is intended for use by healthcare professionals in clinical settings. By providing a dual-function pathway, it allows for the removal of gastric contents while simultaneously delivering nutritional support, thereby managing patient gastrointestinal needs efficiently.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for patients requiring gastric decompression and simultaneous enteral feeding.

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

MAR - 2 1999

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

Re: K984629

Moss Tubes, Inc. Nasal Tube -- Mark IV Dated: December 22, 1998 -Received: December 30, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 BSS

Dear Mr. Schlakman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We have reviewed your ooking notify notications for use stated in the enclosure) to legally marked predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the mankeled predicate de not manded beliments of the been reclassified in accordance with the provisions of the sames been Medical Device Aniendhients, or to devices that have boon receive, subject to the general controls of coline r coelar rood, Drag, and Oountolo not (Nor) 100) 1000 requirements for annual regulrements for annual registration, listing of proviolo of the Fite Frie general ce, 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 n your action is than additional controls. Existing major regulations affecting your device can be found in the Code of De Subject o Succraditional obtirolo: Extrang Major Hajaritaliy equivalent determination assumes onnliance with r carran Regulations, This a r, - and otice requirements, as set forth in the Quality System Regulation (QS) for the Outlier. Good Manadatanny (11 CFR Part 820) and that, through periodic QS inspections, the Food and Mouldingstration (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 rogulatory action. In addition, - Dr. may pour 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 rinding 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 if you ucolle uposic da not for your control 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.

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/16 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus symbol, with three intertwined snakes representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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## Exhibit IU

510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME:

Moss Tubes, Inc. Nasal Tube - Mark IV

INDICATIONS FOR USE:

-

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Used for decompression and simultaneous internal feeding.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|--------------------------------------------------|----|
| | OR |
| Over-The-Counter-Use<br>(Optional Format 1-2-96) | |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K984629 |
|---------------|---------|
|---------------|---------|

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