ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S

K021493 · Andersen Products, Inc. · KNT · Aug 30, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021493
• Device Name: ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
• Applicant: Andersen Products, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis, cholecystitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed.

Device Story

Sterile, disposable, bilumenal medical-grade vinyl nasogastric tube; features radiopaque vent tube, 24 round aspirating ports, anti-reflux filter, and lubricated polyethylene stylet. Tubes include markings to assist physician during insertion/positioning. Used in clinical settings to maintain continuous gastric evacuation in fasting patients. Device facilitates removal of swallowed air, saliva, gastric secretions, or fresh blood; aids management of conditions like pancreatitis, cholecystitis, post-operative ileus, and peptic ulcers. Physician-operated.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Medical-grade vinyl tube; polyethylene stylet; bilumenal design; radiopaque vent; 24 round aspirating ports; anti-reflux filter. Sterile, disposable. No electronic components or software.

Indications for Use

Indicated for fasting patients requiring continuous gastric evacuation of air, saliva, secretions, or blood due to conditions like pancreatitis, cholecystitis, post-operative ileus, or peptic ulcer management.

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

• Andersen® Nasogastric Tube with Stylet (AN 10S), K935688

Submission Summary (Full Text)

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# AUG 3 0 2002

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# 510 (k) Summary

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| Trade Name | Andersen® Nasogastric Tube with Stylet (AN 11S, 13S, 14S and<br>18S) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Andersen Products, Inc. 3202 Caroline Drive Haw River, NC 27258 |
| Device Generic<br>Name | Nasogastric tube |
| Classification | Nasogastric tubes have been classified as Class II. No performance<br>standards have been established under Section 514 of the Food, Drug<br>and Cosmetic Act for gastrointestinal tubes. |
| Predicate<br>Device | Andersen® Nasogastric Tube with Stylet (AN 10S), K935688 |
| Device<br>Description | Sterile, disposable, bilumenal, medical grade vinyl nasogastric tube<br>with radiopaque vent tube, 24 round aspirating ports, and anti-reflux<br>filter. Includes a lubricated polyethylene stylet. The tubes are<br>marked to aid in positioning the tube during passage. |
| Indications for<br>Use | The Andersen® Nasogastric Tube is indicated in those situations<br>where the physician desires to keep the stomach continuously and<br>completely evacuated of swallowed air, swallowed saliva, gastric<br>secretions or fresh blood in a fasting patient for a prolonged period,<br>such as pancreatitis, cholecystitis, post-operative ileus and non-<br>operative management of peptic ulcer. It is also indicated to keep the<br>stomach evacuated of fresh blood once clots have been removed. |
| Safety and<br>Performance | No new risks were added by the modification. In support of this<br>Special 510(k), Andersen Products, Inc. has provided a declaration of<br>conformity to 21 CFR § 820.30 Design Control requirements. |
| Conclusion | Based on the indications for use and comparison to its predicate<br>device, the Andersen® Nasogastric Tube with Stylet has been shown<br>to be safe and effective for its intended use. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### AUG 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wendy Hedrick Director Quality Assurance/Regulatory Affairs Andersen Products. Inc. Health Science Park 3202 Caroline Drive HAW RIVER NC 27258

#### Re: K021493 Trade/Device Name: Andersen Nasogastric Tube with Stylet (AN 11S, 13S, 14S and 18S) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II

Dated: July 29, 2002 Received: July 31, 2002

Product Code: 78 KNT

Dear Ms. Hedrick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (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.

MP

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

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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## Indications for Use Statement

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| 510(k) Number | K021493 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Andersen® Nasogastric Tube with Stylet (AN 11S, 13S, 14S and 18S) |
| Indications for Use | The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis. cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;"></span> ✓ </div> | OR | Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
|-------------------------|------------------------------------------------------------------------|----|----------------------|--------------------------------------------------|
| (Per 21 CFR § 801. 109) | | | | |

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | <span style="text-decoration: overline;">K021493</span> |
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