ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET

K092628 · Alan Reid · KNT · May 20, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092628
• Device Name: ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET
• Applicant: Alan Reid
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpylorie placement. The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".

Device Story

Pediatric enteral feeding tubes and extension sets facilitate delivery of fluids/formula into the stomach. Tubes feature integral female fittings, two distal eyelets, shaft markings, and radiopaque lines; available in 4-10 Fr diameters. Extension sets connect feeding formula bags to tubes. Components are manufactured from PVC, silicone, or polyurethane. Used in hospitals or clinical environments by healthcare professionals. Connectors include standard IV luer lock or non-IV options to prevent misconnection. Devices are provided sterile. Clinical benefit includes reliable, short-term enteral nutrition delivery for pediatric populations.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with ISO 594/1, BS EN 1615:2000, and BS EN 1618:1997. Tests included gauging of luer/non-luer fittings, tensile strength, air/liquid leakage, separation force, stress cracking, unscrewing torque, and ease of assembly. Results demonstrated that the feeding tubes and extension sets met industry standard requirements.

Technological Characteristics

Materials: PVC, silicone, polyurethane. Design: 4-10 Fr diameters, integral radiopaque line, two distal eyelets, shaft markings. Connectors: IV luer lock or non-IV slip fit. Standards: ISO 594/1, BS EN 1615:2000, BS EN 1618:1997. Sterilization: Provided sterile.

Indications for Use

Indicated for neonates, infants, and pediatric patients requiring nasogastric or orogastric enteral feeding for < 30 days. Not indicated 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

• NeoDevices - K020005 - Infant Feeding Tubes
• NeoChild - K082710 - Infant Feeding Tube
• Argyle / Kendall - K820442 Feeding Tube

Reference Devices

• K890396 - Multi-Med enteral feeding set

Submission Summary (Full Text)

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K092628
Page 1 of 3

## 510(k) Summary Page 1 of 3 12-May-10

MAY 2 0 2010

| Alan Reid | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| PO Box 660 | |
| 2 South Winchester Street | Tel - 603-357-8733 |
| West Swanzey, NH 03459 | Fax - 603-357-0732 |
| Official Contact: | Alan Reid |
| Proprietary or Trade Name: | Pediatric Enteral Feeding Tube and Accessories<br>Pediatric Enteral Feeding Tube Extension sets |
| Common/Usual Name: | Feeding Tube or NG /OG Tube |
| Classification Name: | Tubes. Gastrointestinal (and Accessories) |
| Predicate Devices: | NeoDevices - K020005 - Infant Feeding Tubes<br>NeoChild -- K082710 - Infant Feeding Tube<br>Argyle / Kendall - K820442 Feeding Tube |

#### Device Description:

The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".

The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.

The Enteral extension sets are provided in various lengths and various configurations of components.

### Indications for Use:

The Pediatric Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric placement, limited to < 30 day placement and not intended for transpyloric placement.

The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings (which have been marked "For enteral feeding only").

#### Environment of Use:

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

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| rison to Predicate Devices: Attribute | Proposed device | Predicates |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Locations<br>General | To be placed into the stomach to permit the introduction of fluids as directed by the physician. | To be placed into the stomach to permit the introduction of fluids as directed by the physician.<br>K020005-Infant Feeding Tube |
| Type of placement | Nasogastric or orogastric<br>Not for transpyloric placement. | Nasogastric or orogastric. Not for transpyloric placement.<br>K020005 - Infant Feeding Tube |
| Length of placement | < 30 days | < 30 days - K020005 - Infant Feeding Tube |
| Intended for single patient use | Yes | Yes - K020005-Infant Feeding Tube |
| Prescription required | Yes | Yes - K020005-Infant Feeding Tube |
| Intended population | Neonates, Infants, Pediatrics | Neonates / Infants / Pediatrics -K020005 - Infant Feeding Tube |
| Intended Environment of Use | Hospital or environments where placement of a Feeding tube is required. | Hospital or environments where placement of a Feeding tube is required. K020005 - Infant Feeding Tube |
| Design Features | | |
| Provided in various diameters | 4, 5, 6.5, 8, 10 Fr | Yes-K020005-Infant Feeding Tube (4, 5, 6.5, 8 Fr)<br>Yes-K820442 - Argyle / Kendall (10 Fr) |
| Extension sets for use with enteral feeding tubes to deliver fluids and connector between the feeding tube and the fluid source | Yes, made of PVC<br>Available in various lengths<br>Intended for use with enteral feeding tubes | Yes, made of PVC<br>K890396-Multi-Med enteral feeding set<br>K082710-NeoChild extension set |
| Connector options | Non-IV slip fit female connection<br>Must be used with the specified syringe with integral mating non-IV connector<br>Standard IV luer | IV and Non-IV<br>K082710-NeoChild with non-IV connector |
| (2) eyelet holes near tip | Yes | Yes-K020005 - Infant Feeding Tube |
| Radiopaque line | Yes | Yes - K020005 - Infant Feeding Tube |
| Markings along the length of the tubing | Yes | Yes - K020005-Infant Feeding Tube |
| Materials | PVC<br>Silicone<br>Polyurethane | K020005 - Infant Feeding Tube - PVC<br>K082710-NeoChild - silicone, polyurethane |
| Attribute | Proposed device | Predicates |
| Packaging | Feeding tubes<br>Extension Sets<br>Syringe – non-sterile | K020005 - Infant Feeding Tube<br>K890396 – Multi-Med<br>K082710 - NeoChild – Infant Feeding Tube and accessories with non-IV connector<br>K082710 - NeoChild – Infant Feeding Tube and accessories with non-IV connector |
| Sterile | Offered with and without extension sets of various lengths and connectors | Yes |
| Performance Testing | None under Section 514 | Yes |
| | Performance testing was performed in accordance to<br>ISO 594/1<br>BS EN 1615:2000<br>BS EN 1618:1997 | Gauging of 6% luer conical fittings<br>Gauging of non-luer conical fittings<br>Tensile strength and properties of tubing and connectors<br>Air leakage test of tubing and connectors<br>Liquid leakage test of tubing and connectors<br>Separation force<br>Stress cracking<br>Unscrewing torque of fitting assembly<br>Ease of assembly<br>Resistance to overriding the threads of lugs of the fitting |
| The above listed performance / bench tests were performed and shown to demonstrate that the Enteral<br>Feeding tube, accessories and Enteral extensions sets either met the requirements of the industry standards | | |

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K092628
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510(k) Summary

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Mr. Alan Reid c/o Mr. Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-2958

MAY 2 0 2010

Re: K092628

Trade/Device Name: Pediatric Enteral Feeding Tube and Accessories Pediatric Enteral Feeding Tube and Extension sets Regulation Number: 21 CFR §876. 5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 12, 2010 Received: May 14, 2010 . . . .

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You must of the new with all the Act's requirements, including, but not limited to: registration and listing (21 CFP Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting 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

Page 1 of 1

## 510(k) Number:

K092628

Device Name:

Pediatric Enteral Feeding Tube and Accessories Pediatric Enteral Feeding Tube Extension sets

Indications for Use:

The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpylorie placement.

The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".

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)

Heili Lému

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

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