INFANT FEEDING TUBES

K020005 · Promedic, Inc. · KNT · Jul 16, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020005
• Device Name: INFANT FEEDING TUBES
• Applicant: Promedic, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 16, 2002
• 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) PVC tube used for nasogastric or orogastric fluid delivery in infants. Features include integral female luer fitting, two distal eyelets, shaft markings, and radiopaque line. Device is provided sterile for single-patient use in hospital or clinical environments. Placed by healthcare professionals to facilitate enteral nutrition or fluid administration. Benefits include reliable access for infant feeding; limited to short-term (<30 days) use.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: PVC tubing and connector. Design: 5, 6, 8 French diameters; 14.5", 35", 41" lengths. Features: Integral female luer fitting, two distal eyelets, shaft markings, radiopaque line. Sterile. No energy source.

Indications for Use

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

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

• Vygon - Infant Feeding Tubes (K925854)
• Klein-Baker - Neo-Care Feeding Tube (K861090)
• Knott Gastric tube (K971354)

Submission Summary (Full Text)

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# 'JUL 1 6 2002

### Non-Confidential Summary of Safety and Effectiveness

| | Page 1 of 2<br>April 16, 2002 |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Classification Name: | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices: | Vygon - Infant Feeding Tubes - K925854<br>Klein-Baker - Neo-Care Feeding Tube - K861090<br>Knott Gastric tube - K971354 |

### Device Description: ----------------------------------------------------------------------------------------------------------------------------------------------------------

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 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.

| Intended Use: | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated 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.<br>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. |

rate of the comments of

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### Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 April 16, 2002

## Comparison to Predicate Devices: Devices: 10 Comparison 1

| Attribute | Proposed device | Predicate Vygon Infant<br>Feeding Tube - K925854 |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------|
| Intended use | | |
| To be placed into the stomach to<br>permit the introduction of fluids<br>as directed by the physician.<br>Nasogastric or orogastic<br>placement. | Yes | Yes |
| Intended for single patient use for<br>a duration of < 30 days | Yes | Yes Klein-Baker - Neo-<br>Care Feeding Tube -<br>K861090 |
| 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 |
| Design Features | | |
| Provided in various diameters<br>from 4 - 12 Fr | 5,6,8 Fr | Yes, 4 - 12 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 |
| Materials | | |
| Tubing and Connector - PVC | Yes | Yes- Knott Gastric tube -<br>K971354 |
| Packaging | | |
| Sterile | Yes | Yes |
| Performance | | |
| 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 - Vygon Infant Feeding Tube - K925854, Knott Gastric tube - K971354, and Klein-Baker - Neo-Care Feeding Tube - K861090.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 1 6 2002

Re: K020005

Trade/Device Name: Infant Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories

Regulatory Class: II Product Code: 78 KNT Dated: April 16, 2002 Received: April 17, 2002

#### Dear Mr. Dryden:

Mr. Paul Dryden

6329 W. Waterview Ct.

MCCORDSVILLE IN 46055

President ProMedic, Inc.

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. Ilisting 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 mav 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 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 Cbrogdon

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

| 510(k) Number: | K020005 (To be assigned) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Infant Feeding Tube |
| Intended Use: | The Infant Feeding tube is intended to be placed<br>into the stomach to permit the introduction of fluids as<br>directed by the physician. Intended for nasogastric or<br>orogastric placement. Limited to less than 30-day<br>placement. Not intended for transpyloric placement. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _XX (Per CFR 801.109)

or

Over-the-counter use__________________________________________________________________________________________________________________________________________________________

Nanay bradon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020005