PEDIATRIC FEEDING TUBE

K052903 · Promedic, Inc. · KNT · Nov 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052903
• Device Name: PEDIATRIC FEEDING TUBE
• Applicant: Promedic, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30 day placement. Not intended for transpyloric placement.

Device Story

Infant Feeding Tube is a small-diameter (5, 6, 8 French) medical tube used for nasogastric or orogastric fluid delivery in infants. Device features include an integral female luer fitting, two distal eyelets, shaft markings, and an integral radiopaque line for visualization. Used in hospital or clinical environments by healthcare professionals. Device is provided sterile for single-patient use. Radiopaque line allows clinicians to verify tube placement via imaging. Benefits include safe, temporary access for enteral nutrition or fluid administration.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: PVC (DEHP-free). Dimensions: 5, 6, 8 French diameters; 14.5", 35", 41" lengths. Features: Integral female luer fitting, two distal eyelets, shaft markings, radiopaque line. Sterile. Standalone device.

Indications for Use

Indicated for infants requiring nasogastric or orogastric feeding tube placement for fluid introduction. Limited to <30 days use. Not for transpyloric placement.

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

• ProMedic - Infant Feeding Tubes (K020005)

Submission Summary (Full Text)

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## NOV - 9 2005

# Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

| | | 13-Oct-05 |
|-------------------------------------------------------------------|--------------------------------------------|-----------|
| ProMedic, Inc.<br>6329 W. Waterview Ct.<br>McCordsville, IN 46055 | Tel [phone]<br>Fax [phone] | |
| Official Contact: | Paul Dryden - President | |
| Proprietary or Trade Name: | Infant Feeding Tube | |
| Common/Usual Name: | Feeding Tube or NG /OG Tube | |
| Classification Name: | Tubes, Gastrointestinal (and Accessories) | |
| Predicate Devices: | ProMedic - Infant Feeding Tubes -- K020005 | |

#### Device Description:

The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

| Indications for Use: | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use -- | The Infant Feeding tube is intended to be placed into the stomach<br>to permit the introduction of fluids as directed by the physician. |
| | Intended for nasogastric or orogastric placement. Limited to less<br>than 30 day placement. |
| | Not intended for transpyloric placement. |
| Environment of Use -- | Hospital or environment where placement of a feeding tube is<br>required. |

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### Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 13-Oct-05

| Attribute | Proposed device | Predicate ProMedic Infant<br>Feeding Tube – K020005 |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------|
| <b>Indications for Use</b> | | |
| To be placed into the stomach to<br>permit the introduction of fluids<br>as directed by the physician.<br>Nasogastric or orogastric<br>placement. | Yes | Yes |
| Intended for single patient use for<br>a duration of < 30 days | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population infants | Yes | Yes |
| Intended Environment of Use -<br>Hospital or environments where<br>placement of a Feeding tube is<br>required. | Yes | Yes |
| <b>Design Features</b> | | |
| Provided in various diameters | 5,6,8 Fr | 5,6,8 Fr |
| Standard slip fit female luer<br>connector | Yes | Yes |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length of<br>tubing | Yes | Yes |
| Markings along the length of the<br>tubing | Yes | Yes |
| <b>Materials</b> | | |
| Tubing and Connector – PVC<br>with no DEHP | Yes | Yes |
| <b>Packaging</b> | | |
| Sterile | Yes | Yes |
| <b>Performance</b> | | |
| None under Section 514 | Yes | Yes |

#### Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicate -- ProMedic Infant Feeding Tube - K020005.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text appears to be "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged along the top and sides of the circle. The central symbol resembles a bird with three curved lines extending from its body, creating a sense of motion or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Mr. Paul Dryden President ProMedic, Inc. 6329 W. Waterview Court MCCORDSVILLE IN 46055

Re: K052903

Trade/Device Name: Infant Feeding Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: October 13, 2005 Received: October 14, 2005

Dear Mr. Dryden:

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 (Premarket Approval), 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.

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 (0S) 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) 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.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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Infant Feeding Tube

Page 1 of 1

| 510(k) Number: | K052903 (To be assigned) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Infant Feeding Tube |
| Indications for Use: | The Infant Feeding tube is intended to be placed into the<br>stomach to permit the introduction of fluids as directed by<br>the physician. Intended for nasogastric or orogastric<br>placement. Limited to < 30 day placement. Not intended<br>for transpyloric placement. |

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C hogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 052903 510(k) Number _ 1