AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

K100526 · Kentec Medical, Inc. · FPD · Apr 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100526
• Device Name: AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
• Applicant: Kentec Medical, Inc.
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Amertius Entral™ Feeding Tube is intended for nasogastric 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

Ameritus Entral™ Feeding Tubes are single-lumen catheters used for nasogastric delivery of liquid nutrition and medication. Available in polyurethane or silicone, the tubes feature an orange color-coded enteral connector, a tethered closure plug, and a radiopaque stripe for X-ray visualization. Centimeter markings and printed French size/length assist in placement and migration monitoring. The device is sterile, latex-free, and DEHP-free. Used in clinical settings for neonatal and pediatric patients, the tube is placed by healthcare professionals. The radiopaque stripe allows clinicians to confirm placement via X-ray, ensuring safe delivery of nutrition directly to the gastrointestinal tract. The device is intended for short-term use (up to 30 days).

Clinical Evidence

Bench testing only. Performance testing and design verification demonstrated that both polyurethane and silicone tube families perform according to intended use and are equivalent to predicate devices.

Technological Characteristics

Single-lumen catheter; materials: polyurethane or silicone; radiopaque stripe for visualization; orange color-coded enteral connector; tethered closure plug; sterile; latex-free; DEHP-free; centimeter markings for placement.

Indications for Use

Indicated for nasogastric delivery of liquid nutritional media in neonatal and small pediatric patients; not for use exceeding 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 Polyurethane Enteral Feeding Tube (K082238)
• NeoMed Silicone Enteral Feeding Tube (K072881)

Submission Summary (Full Text)

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Premarket Notification - Ameri

Image /page/0/Picture/1 description: The image shows the logo for KENTEC MEDICAL, INC. The logo features a stylized letter "A" on the left, with the company name "KENTEC" in bold, sans-serif font to the right. Below "KENTEC" is the text "MEDICAL, INC." in a smaller font size.

# APR 2 2 2010

## SUMMARY OF SAFETY & EFFECTIVENESS

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

| APPLICANT | Kentec Medical, Inc.<br>17871 Fitch<br>Irvine, CA 92614<br>Tel: [phone]<br>Fax: [phone] |
|---------------|---------------------------------------------------------------------------------------------------|
| OFFICIAL | Keith Books |
| OFFICIAL | Keith Rooks |
| CORRESPONDENT | QA/RA Manager |
| | Tel: [phone] |
| | Fax: [phone] |
| | [e-mail] |

| TRADE NAME | Ameritus® Entral™ Polyurethane Feeding Tube |
|------------|---------------------------------------------|
| | . Ameritus® Entral™ Silicone Feeding Tube |

| COMMON OR USUAL NAME | Feeding Tube |
|---------------------------|------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME | Gastrointestinal Tubes and accessories |
| DEVICE CLASSIFICATION | Class II per 21CFR §876.5980 |
| PRODUCT CODE | FPD |
| PREDICATE DEVICE<br>NAMES | NeoMed Polyurethane Enteral Feeding Tube (K082238)<br>NeoMed Silicone Enteral Feeding Tube (K072881) |

## SUBSTANTIAL EQUIVALENCE

The Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are substantially equivalent to the Neomed Polyurethane and Silicone Enteral Feeding Tubes.

The devices have the same method of operation, delivery of fluids including liquid nutrition media and medication through single lumen catheter. Bench testing demonstrated that Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are functionally equivalent to the predicate devices and that any minor differences do not affect safety or effectiveness.

## DESCRIPTION OF DEVICE

The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.

The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding

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Premarket Notification - Ameritu

Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.

The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.

## INDICATIONS FOR USE

The Amerius Entral™ Feeding Tube is intended for nasogastric 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

Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices.

#### CONCLUSION

Based on performance testing test results, Kentec Medical can conclude that the Ameritus Entral™ Feeding tube two families made of either Polyurethane or Silicone are equivalent to their respective predicate device with respect to intended use and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a stamp or seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

Mr. Keith Rooks RA/QA Manager Kentec Medical, Inc. 17871 Fitch IRVINE CA 92614

APR 2 2 2010

· Re: K100526 Trade/Device Name: Ameritus Entral" Feeding Tubes Regulation Number: 21 CFR §876.5980 · Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: April 13, 2010

Received: April 13, 2010

Dear Mr. Rooks:

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 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); 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 (OS) 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/CDRHOffices/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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K100526 510(k) Number (if known):

Device Name: Ameritus Entral™ Feeding Tubes

Indications For Use:

The Amertius Entral™ Feeding Tube is intended for nasogastric 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 (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)

(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Device 510(k) Number

Kentec Medical, Inc.

CONFIDENTIAL

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