NON-IV ADAPTER FOR INFANT NG TUBE

K072756 · Promedic, Inc. · KNT · Dec 19, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072756
• Device Name: NON-IV ADAPTER FOR INFANT NG TUBE
• Applicant: Promedic, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 19, 2007
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

A non-IV connector for use with Infant Feeding tubes that are 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 < 30 day placement. Not intended for transpyloric placement.

Device Story

Infant feeding tube kit consisting of small-diameter PVC tube (5, 6, 8 French) with integral female non-IV connector, two distal eyelets, shaft markings, and radiopaque line; includes non-sterile syringe with matching non-IV male connector. Used in hospital or home settings by clinicians or caregivers to deliver fluids into the stomach. Modification from standard slip-fit luer to non-IV connector prevents accidental IV connection. Device provides enteral access; healthcare providers use markings and radiopaque line to verify placement; output is fluid delivery to stomach. Benefits include reduced risk of misconnection errors.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: PVC tubing and connector. Dimensions: 5, 6, 8 French diameters; 14.5", 35", 41" lengths. Features: Two distal eyelets, shaft markings, integral radiopaque line. Connector: Non-IV slip-fit female. Sterilization: Sterile (tube), non-sterile (syringe). Connectivity: None.

Indications for Use

Indicated for infants and pediatric patients requiring nasogastric or orogastric feeding tube placement for fluid administration. Limited to < 30 days duration. Contraindicated 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 - K052903

Submission Summary (Full Text)

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## Non-Confidential Summary of Safety and Effectiveness

| | Page 1 of 2 |
|--|-------------|
| | 26-Sept-07 |

| ProMedic, Inc. | Tel [phone] |
|-------------------------------|--------------------|
| 3460 Pointe Creek Court #102. | Fax [phone] |
| Bonita Springs, FL 34134 | |

| Official Contact: | Paul Dryden |
|-------------------|-------------|
|-------------------|-------------|

| | DEC 1 9 2007 |
|--|--------------|
|--|--------------|

| Proprietary or Trade Name: | Infant Feeding Tube with Non-IV fittings |
|----------------------------|-------------------------------------------|
| Common/Usual Name: | Feeding Tube or NG /OG Tube |
| Classification Name: | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices: | ProMedic - Infant Feeding Tubes - K052903 |

#### Device Description:

The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are 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. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.

### Indications for Use:

A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stornach to permit the introduction of fluids as directed by the physician. Intended for nasogastric placement. Limited to < 30 day placement. Not intended for transpyloric placement.

### Environment of Use:

Hospital or environment where placement of a feeding tube is required.

| Attribute | Proposed device with<br>modification | Predicate ProMedic Infant<br>Feeding Tube - K052903 |
|---------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Indications<br>General | To be placed into the stomach to<br>permit the introduction of fluids<br>as directed by the physician. | To be placed into the stomach<br>to permit the introduction of<br>fluids as directed by the<br>physician. |
| Type of placement | Nasogastric or orogastric<br>Not for transpyloric placement. | Nasogastric or orogastric<br>Not for transpyloric<br>placement. |
| Length of placement | < 30 days | < 30 days |
| Intended for single patient use | Yes | Yes |
| Prescription | Yes | Yes |

### Comparison to Predicate Devices:

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4072056
may 2012

# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 26-Sept-07

| Attribute | Proposed device with modification | Predicate ProMedic Infant<br>Feeding Tube – K052903 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended population | Infants / pediatrics | Infants / pediatrics |
| Intended Environment of Use | Hospital, home or environments<br>where placement of a Feeding<br>tube is required. | Hospital, home or environments<br>where placement of a Feeding tube is<br>required. |
| Design Features | | |
| Provided in various diameters<br>from 4 - 12 Fr | 5, 6, 8 Fr | 5, 6, 8 Fr |
| Connector | Non-IV slip fit female<br>connection<br>Must be used with an<br>appropriate syringe with non-<br>IV male mating connector | Standard slip fit female luer |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length<br>of tubing | Yes | Yes |
| Markings along the length of<br>the tubing | Yes | Yes |
| Materials | | |
| Tubing and Connector - PVC | Yes | Yes |
| Packaging | | |
| Sterile | Yes<br>Syringe offered non-sterile | 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 - ProMedic Infant Feeding Tube - K052903.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

Mr. Paul Dryden President ProMedic, Inc. 3460 Pointe Creek Court, #102 BONITA SPRINGS FL 34134

Re: K072756

> Trade/Device Name: Feeding tube adapter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 26, 2007 Received: September 27, 2007

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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# Page 2 - Mr. Paul Dryden

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 the labeling regulation, 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). 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.dsmamain.html.

Sincerely yours,

Herbert Lemon for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# 1072756

# Indications for Use Statement

Page 1 of 1

(To be assigned) 510(k) Number:

Device Name:

Feeding tube adapter

Indications for Use:

A non-IV connector for use with Infant Feeding tubes that are 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 < 30 day placement. Not intended for transpyloric placement.

Prescription Use XX (Part 21 CFR 801 Subpart D) 01

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)

Herbert Leiner

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