NEXT GENERATION SALEM SUMP

K040388 · Kendall · FEG · May 17, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040388
• Device Name: NEXT GENERATION SALEM SUMP
• Applicant: Kendall
• Product Code: FEG · Gastroenterology, Urology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.

Device Story

Next Generation Salem Sump is a dual lumen nasogastric tube featuring a multiport connector/valve. Device facilitates gastric decompression and delivery of fluids (irrigation, nutrition, medication). Operates via dual lumen PVC tubing with external ports for connection to vacuum adaptors, feeding sets, and irrigation syringes. Includes integrated mechanism to prevent gastric reflux from vent lumen. Used in clinical settings for patients requiring gastric decompression. Healthcare providers operate the device to manage gastric contents and administer fluids/medication. Benefits include efficient decompression and simplified switching between device functions via the multiport valve.

Clinical Evidence

Bench testing only. Testing conducted to demonstrate design equivalence to predicate devices and compliance with EN1615:2000 standards.

Technological Characteristics

Dual lumen PVC nasogastric tube; multiport connector/valve; external connection ports for vacuum/feeding/irrigation; anti-reflux mechanism. Complies with EN1615:2000.

Indications for Use

Indicated for patients requiring gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.

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

• Kendall Salem Sump (naso gastric) tube with Anti-Reflux Valve (K935781/A)
• Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter (K960176)
• ICU Medical Lopez Valve (K915171)
• ICU Medical Lopez Valve with NG tube (K921104)

Submission Summary (Full Text)

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K040388
lct 2

15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 * [phone]

| MAY 1 7 2004 | 510(k) Premarket Notification<br>Next Generation Salem Sump |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Section H - 510(K) Summary | |
| Date Summary<br>Was Prepared: | February 12, 2004 |
| Submitter's<br>Information: | The Kendall Company<br>Division of Tyco Healthcare Group, LP<br>15 Hampshire Street<br>Mansfield, MA 02048<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Jim Welsh<br>Director, Regulatory Affairs<br>The Kendall Company<br>Division of Tyco Healthcare Group, LP<br>Telephone: [phone]<br>Fax: [phone] |
| Device Trade<br>Name: | Next Generation Salem Sump |
| Device Common<br>Name: | Tube, double lumen for intestinal decompression and/or intubation |

Classification Panel: Gastroenterology

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Kendall Salem Sump (naso gastric) tube with Anti-Reflux Valve, 510(k) number K935781/A, u cleared on January 10, 1995.
- Bard (Davol) NasoGastric Sump tube with PreVent Anti-Reflux filter, 510(k) number K960176, cleared on July 24, 1996.
- ICU Medical Lopez Valve, 510(k) number K915171, cleared February 7, 1992
- . ICU Medical Lopez Valve with NG tube, 510(k) number K921104, cleared on October 26, 1992.

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510(k) Premarket Notification Next Generation Salem Sump

## Section H - 510(K) Summary

Device Description: The Next Generation Salem Sump is a dual lumen Naso Gastric tube with a multiport connector/valve to facilitate switching among the various function of the device.

Intended Use: The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.

Product Comparison: The proposed device has the same technological characteristics as the predicate devices. Both the proposed device and the predicate devices are intended to be used for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication. The construction of both the proposed and predicate devices is based upon a dual lumen PVC nasogastric tube, with external connection ports suitable for connection with commonly available devices such as vacuum adaptors, feeding sets, and irrigation syringes. Both the proposed device and the predicate devices are equipped with a mechanism to prevent gastric reflux from the vent lumen of the device.

Nonclinical Testing: Testing was conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the industry accepted criteria for such devices, as defined in EN1615:2000.

James E. Clark

alm Welsh Director, Regulatory Affairs Tyco Healthcare/Kendall

2-12-04

Date

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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol of an eagle with three stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2004

Mr. James Welsh Director, Regulatory Affairs The Kendall Company Tyco Healthcare Group, LP 15 Hampshire Street MANSFIELD MA 02048

Re: K040388

Trade/Device Name: Next Generation Salem Sump Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 FEG Dated: February 12, 2004 Received: February 17, 2004

Dear Mr. Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bated in the 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) that do not require approval of a premarket approval application (PMA). and Ocometer for , roy the 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 (Spccial Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device in your Section 510(k)
. I alleging to begin of the first of also to tick answelesses of your device to a logally This letter will allow you to ocgli marketing of substantial equivalence of your device to a legally premarket nothication. The PDA intonty of submands of Erray of 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), please If you desire specific advice to your device on our lasting of the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the promotion to , please note the regulation entitled, "Misbranding Office of Compliance at [phone]. Fab 1.97.97) you may obtain. Other general by reference to premarket notification (21 or Fr x are events and from the Division of Small information on your responsionalities uncer assistance at its toll-free number [phone] or
Manufacturers, International and Consuminent in associaded damamain huml Manufacturers, International and Collisamer Assisterial Assisted on the Contracted on the Collection of the Collection of the Internet

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048  •  [phone]

510(k) Premarket Notification Next Generation Salem Sump

## Appendix 1

## Indications for Use Statement

Device Name:

Next Generation Salem Sump

Indications for Use:

The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, The Next Generation Oalch Outlip is internable for gast on, during the time period that gastric decompression is required.

Please Do Not Write Below This Line – Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Nancic Brogdon
(Division Sign-Off)

Division of Reproductive, Abo and Radiological Devic

**510(k) Number** K040388