NEOMED POLYURETHANE FEEDING TUBE

K082238 · Neomed, Inc. · FPD · Oct 1, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082238
• Device Name: NEOMED POLYURETHANE FEEDING TUBE
• Applicant: Neomed, Inc.
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Oct 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

Device Story

Polyurethane single lumen catheter for delivery of liquid nutritional media to neonatal and small pediatric patients via nasogastric or orogastric route. Device components include feeding tube, hub with tethered connection closure plug, and connector. Used in clinical settings for short-term enteral feeding (up to 30 days). Provides a pathway for nutrition; does not involve active sensing, processing, or electronic output. Benefits patient by facilitating enteral nutrition delivery.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Design verification testing demonstrated performance equivalent to predicate device.

Technological Characteristics

Polyurethane single lumen catheter; hub with tethered connection closure plug; connector. Biocompatible materials per ISO 10993. Mechanical delivery system; no energy source or software.

Indications for Use

Indicated for nasogastric or orogastric delivery of liquid nutritional media in neonatal and small pediatric patients. Not for use beyond 30 days.

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

• NeoMed Silicone Enteral Feeding Tube (K072881)

Submission Summary (Full Text)

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K082238

SUMMARY OF SAFETY & EFFECTIVENESS

Image /page/0/Picture/3 description: The image shows the logo for "NEOMED incorporated". The word "NEOMED" is in a sans-serif font, with a stylized "O" that has a small swirl above it. Below "NEOMED" is the word "incorporated" in a smaller, cursive font.

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | NeoMed<br>FDA Owner/Operator #10022926<br>507 Hickory Ridge Trail<br>Suite 120<br>Woodstock, GA 30188<br>Tony Lair, President<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT | Penny Northcutt, RAC, CQA<br>Regulatory Consultant for NeoMed, Inc.<br>REGSolutions, LLC<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME: | NeoMed Polyurethane Feeding Tube |
| CLASSIFICATION NAME: | Gastrointestinal Tube and Accessories |
| DEVICE CLASSIFICATION<br>AND PRODUCT CODE | Class II per 21 CFR §876.5980<br>Product Code: 78 FPD |
| PREDICATE DEVICE NAME | NeoMed Silicone Enteral Feeding Tube (K072881)<br>Cleared January 8, 2008 |

#### SUBSTANTIAL EQUIVALENCE:

The NeoMed Polyurethane Feeding Tube is substantially equivalent to the NeoMed Silicone Enteral Feeding Tube cleared under K072881.

Both devices have the same method of operation, delivery of liquid nutrition media through a single lumen catheter. Bench testing has demonstrated that the NeoMed Polyurethane Feeding Tube is functionally equivalent to predicate NeoMed Silicone Enteral Feeding Tube, and that any minor differences do not affect safety or effectiveness.

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K082238
292

### DESCRIPTION OF THE DEVICE:

The NeoMed Polyurethane Feeding Tube is a polyurethane single lumen catheter that is used to deliver liquid nutritional media.

The device consists of the following main components: a feeding tube single lumen catheter, a hub with tethered connection closure plug, and a connector.

#### INDICATIONS FOR USE:

The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

#### PERFORMANCE DATA:

The NeoMed Polyurethane Feeding Tube materials that come in direct contact with the patient have a long history of use in catheter and feeding tube manufacture and are biocompatible according to ISO 10993. Design verification performance test results demonstrate that the NeoMed Polyurethane Feeding Tube performs its intended use and is equivalent to the predicate device.

#### CONCLUSION:

Based on the performance testing, it can be concluded that the NeoMed Polyurethane Feeding Tube is equivalent to the predicate NeoMed Silicone Enteral Feeding Tube with respect to intended use and technological characteristics.

NeoMed Polyurethane Feeding Tube Confidential

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

OCT 01 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NeoMed, Inc. c/o Ms. Penny Northcutt, RAC Official Correspondent Regsolutions, LLC 717 Lakeglen Drive SUWANEE GA 30024

K082238 Re:

> Trade/Device Name: NeoMed Polyurethane Feeding Tube Regulation Number: 21 CFR \$876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD, BSS Dated: September 17, 2008 Received: September 19, 2008

Dear Ms. Northcutt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 (PMA), 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.

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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 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/odrh/industry/support/index.html.

Sincerely yours,

Joppu M. Whang

Joyce M. Whang, Ph.D. 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

510(k) Number (if known):

K082238

Device Name: NeoMed Polyurethane Feeding Tube

Indications For Use:

The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulsen

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

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Special 510(k): Design Modification NeoMed, Inc.

NeoMed Polyurethane Feeding Tube Confidential

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