KNOTT NG TUBE

K971354 · Michael M. Knott, M.D. · FEG · Nov 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971354
• Device Name: KNOTT NG TUBE
• Applicant: Michael M. Knott, M.D.
• Product Code: FEG · Gastroenterology, Urology
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.

Device Story

Knott nasogastric tube; double-lumen PVC tube; inserted through nostril into stomach. One lumen for suction/fluids; one for venting. Features pre-formed tip and markings to assist clinician with rotation and advancement during insertion. Used in hospitals, ORs, ICUs, and nursing homes by clinicians. Connects to various vacuum sources. Benefits patient by facilitating gastric decompression or enteral feeding/medication administration.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Double-lumen nasogastric tube made of PVC. Features pre-formed tip and markings for insertion guidance. Connects to external vacuum sources. Provided sterile. No applicable performance standards under Section 514.

Indications for Use

Indicated for adults > 100 lbs requiring nasogastric tube placement for fluid withdrawal, fluid introduction, or stomach gas removal. Used in hospital, OR, nursing home, and ICU settings.

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

• Sherwood - Salem Sump Tube (K810156)

Submission Summary (Full Text)

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Michael M. Knott, M.D. 355 Pine Rose Court Tahoe City, CA 96145

| Non-Confidential Summary of Safety and Effectiveness<br>page 1 of 2<br>November 19, 1997 | | NOV | 19 1997 |
|------------------------------------------------------------------------------------------|--------------------------------------|-----|---------|
| Michael M. Knott, M.D. | Tel - 916-583-9371 | | |
| 355 Pine Rose Court | | | |
| Tahoe City, CA 96145 | | | |
| | | | |
| Official Contact: | Michael M. Knott, M.D. | | |
| Proprietary or Trade Name: | Knott nasogastric tube | | |
| Common/Usual Name: | Nasogastric tube | | |
| Classification Name: | Nasogastric | | |
| Predicate Devices: | Sherwood - Salem Sump Tube - K810156 | | |

## Device Description:

The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inserted through the nostril and into the stomach.

| Indicated Use -- | To permit withdrawal or introduction of fluids into the stomach via<br>a tube placed through the nostril. |
|-----------------------|-----------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Operating Room (OR), nursing homes, ICU and where<br>nasogastric tubes are required. |
| Patient population -- | Adults > 100 lbs. |

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## Non-Confidential Summary of Safety and Effectiveness (continued) page 2 of 2 November 19, 1997

| Comparison to Predicate Devices: | | |
|-----------------------------------------------------------------------------------------------------|------------------|----------------------------------------|
| Attribute | Knott<br>NG Tube | Sherwood Salem<br>Sump Tube<br>K810156 |
| Design | | |
| Provided in various diameters | Yes | Yes |
| Double lumen tube | Yes | Yes |
| One lumen for suction or fluids / one for venting | Yes | Yes |
| Connects to various vacuum sources | Yes | Yes |
| Tip has various holes leading to each lumen | Yes | Yes |
| May be packaged with reflux valve | Yes | Yes |
| Tubing has marking for assisting clinician<br>Pre-formed tip to help with insertion and advancement | Yes | Yes |
| Materials | | |
| Made of PVC | Yes | Yes |
| Packaging | | |
| Provided sterile | Yes | Yes |
| Performance Standards/Specification | | |
| None applicable under Section 514 | Yes | Yes |

## Differences between Other Legally Marketed Predicate Devices

The only difference in the intended device and the predicate device is the pre-formed curve and appropriate markings on the tube to assist the clinician when to rotate the tube while inserting/advancing the tube. This difference is not viewed to be significant when addressing patient safety and effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 9

Michael M. Knott, M.D. c/o Paul E. Dryden, President ProMedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055 Re: K971354

Knott Nasogastric Tube Dated: August 18, 1997 Received: August 22, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 FEG

Dear Dr. Knott:

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 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 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 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 (2) 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/dsmamain.html".

Sincerely yours.

W. Liao 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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Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number: 《♀♀﹛3≤¶ -------------------------------------------------------------------------------------------------------------------------------------------------------(To be assigned)

Device Name: Knott Nasogastric Tube

Intended Use :

To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Rathbun/
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 1971354

or

Prescription Use (Per CFR 801.109)

Over-the-counter use

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