CORFLO ANTI IV ENTERAL FEEDING TUBE

K083210 · Corpak Medsystems · FPD · Dec 29, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K083210
• Device Name: CORFLO ANTI IV ENTERAL FEEDING TUBE
• Applicant: Corpak Medsystems
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Dec 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CORFLO® ANTI IV Enteral Feeding tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

Device Story

CORFLO Anti IV Enteral Feeding Tube (Model 20-xxx) is a medical device designed for enteral nutrition delivery. It is inserted via nasogastric or nasoenteric routes to provide intermittent or continuous feeding to patients. The device is intended for use by healthcare professionals in clinical settings. It functions as a conduit for nutritional fluids, ensuring proper delivery into the gastrointestinal tract. The 'Anti IV' designation indicates design features intended to prevent accidental connection to intravenous systems, thereby enhancing patient safety by mitigating the risk of misconnection errors.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use characteristics.

Technological Characteristics

Enteral feeding tube; nasogastric/nasoenteric form factor; designed with anti-IV connection features to prevent misconnection; materials and construction consistent with standard gastrointestinal feeding tubes.

Indications for Use

Indicated for patients requiring intermittent or continuous enteral nutrition via nasogastric or nasoenteric routes.

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

## DEC 2 9 2008

Ms. Stephanie Wasielewski VP, Regulatory Affairs/Quality CORPAK MedSystems 100 Chaddick Drive WHEELING IL 60090

Re: K083210

> Trade/Device Name: CORFLO Anti IV Enteral Fecding Tube Model number 20-xxx Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: October 29, 2008 Received: October 31, 2008

Dear Ms. Wasielewski:

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 such 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.

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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.

This letter will allow you to begin marketing your device as described in your Section 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;

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Jorpu M. Whang

Joyce M. Whang, Ph.D. Acting 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

The CORFLO® ANTI IV Enteral Feeding tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

or Over-the-counter use

Arqui M. Whang

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(Division Sign Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number.