CORTRAK

K041987 · Viasys Medsystems · KNT · Dec 17, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041987
• Device Name: CORTRAK
• Applicant: Viasys Medsystems
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of enteral feeding tubes of 8 Fr or larger in the stomach or small bowel of patients requiring enteral feeding. For the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

Device Story

CORTRAK System aids clinicians in placing enteral feeding tubes (8 Fr or larger) into stomach or small bowel. Device uses electrical signals to track tube tip position during insertion; provides real-time visual feedback to operator. System consists of electrical components to assist navigation; does not replace X-ray or standard hospital protocols for final placement confirmation before food delivery. Used in clinical settings by qualified operators to improve tube placement accuracy and reduce risk of malposition. Output allows clinician to monitor path of tube in real-time, facilitating bedside placement.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Electrical device for enteral feeding tube placement. Designed for tubes 8 Fr or larger. Operates via electrical signal tracking for navigation. Class II device under 21 CFR 876.5980.

Indications for Use

Indicated for patients requiring enteral feeding who need placement of feeding tubes (8 Fr or larger) in the stomach or small bowel. For use by qualified operators.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

Re: K041987

Trade/Device Name: CORTRAK TM Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: December 10, 2004 Received: December 13, 2004

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 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 as described in your Section 510(k) I mo reter notification. The FDA finding of substantial equivalence of your device to a legally premaince nodicate 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 rr you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/dsmadsmam.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

The CORTRAK™ System is an electrical device designed to aid qualified The CORTRAIR - - 3566m is and Systems feeding tubes of 8 FF or operators in the stomach or small bowel of patients requiring enteral feeding. Eroad mo the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ i (Per 21 CFR 801.109)

or Over-the-counter use ______________________________________________________________________________________________________________________________________________________

David A. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number_