INFANT FEEDING TUBE

K042112 · Marian Medical, Inc. · KNT · Jan 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042112
• Device Name: INFANT FEEDING TUBE
• Applicant: Marian Medical, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.

Device Story

The GuardianCatheter™-Infant Feeding Tube is a sterile, disposable silicone catheter; designed for enteral nutrition delivery. The device is inserted by a clinician through the nares or mouth into the stomach or small bowel of an infant. It functions as a conduit for liquid nutritional diets. The device is intended for use in clinical settings where patients require supplemental or primary enteral feeding due to a functional GI tract. It provides a direct pathway for nutrition, bypassing oral intake difficulties while maintaining GI function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Silicone. Form factor: Catheter. Usage: Sterile, disposable. Energy source: None (mechanical). Connectivity: None.

Indications for Use

Indicated for infants requiring delivery of liquid nutritional diets via the stomach or small bowel through the nares or mouth, provided the patient has a functional GI tract.

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 Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2005

Ms. Sandra Winkler Owner/President Marian Medical, Inc. P.O. Box 5193 DESTIN FL 32540

Re: K042112

K042112
Trade/Device Name: Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: December 24, 2004 Received: January 6, 2005

Dear Ms. Winkler:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your bectorily be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to ttgans and ment date of the Medical Device Amendments, or to commerce prior to they 20, 2011 11:12 provisions of the Federal Food, Drug, de noos may been rout 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 I ou may, dicrororo, maines of the Act include requirements for annual registration, listing of general volurold provisions 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 it may of surfect to additions, 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 I Tease be actived that I termination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must of any I ederal statues and reguirements, including, but not limited to: registration and listing Comply with an the river requirement 801); good manufacturing practice requirements as set (21 CFR Part 807), as only (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 5 0 (k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket notification. THE PDA midnig of saostantial equice 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 if you desire specific advice for your device of our 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 Also, please note the regulation entired, common on your responsibilities under the Act from the 807.97). Tou may obtain other gollerer mironal and Consumer Assistance at its toll-free number (800) DVNSlor of Stilan Manufacturers, internet address http://www.fda.gov/cdrh/dsmadsmamain.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:

510(K) Number: K-042112

Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube) Device Name: Indications For Use:

The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.

Prescription Use Yes (Part 21 CFR 801 Subpart) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

042112

David h. Ferguson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number _

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