ENTRACARE GASTROSTOMY FEEDING TUBE

K092418 · Entracare, LLC · KNT · Oct 23, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K092418
• Device Name: ENTRACARE GASTROSTOMY FEEDING TUBE
• Applicant: Entracare, LLC
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning stomach who require long term feeding support.

Device Story

The EntraCare Gastrostomy Feeding Tube is a medical device designed for long-term enteral nutrition. It is inserted into an established stoma tract in patients with a functioning stomach who are unable to maintain adequate oral intake. The device serves as a conduit for delivering nutritional support directly to the stomach. It is intended for use in clinical or home settings under the guidance of healthcare providers. The device facilitates patient nutrition, thereby supporting physiological health in individuals with compromised oral feeding capabilities.

Clinical Evidence

bench testing only

Technological Characteristics

Gastrostomy feeding tube; intended for placement in an established stoma tract. Technical specifications and material composition are not detailed in the provided documentation.

Indications for Use

Indicated for patients with a functioning stomach requiring long-term enteral feeding support who cannot consume an adequate oral diet; intended for use as a replacement gastrostomy tube in an established stoma tract.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Susan Curry Director of QA/QC & Regulatory Compliance EntraCare, LLC 11315 Strang Line Road LENEXA KS 66215

OCT 2 3 2009

Re: K092418

Trade/Device Name: EntraCare Gastrostomy Feeding Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 5, 2009 Received: August 6, 2009

Dear Ms. Curry:

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 conceming your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Ms. Susan Curry

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 (reporting of medical device-related 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/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,

Vorgu H. Whay

Janine M. Morris, Director (Acting) ڪم Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Premarket Notification 510(k) Traditional

KD92418
181

## 4.0

## INDICATIONS FOR USE STATMENT

The statement of Indications for Use for the Gastrostomy Tube, in compliance with 21 CFR 807.87(e), is provided below:

| Applicant: | EntraCare LLC |
|----------------------|------------------------------------|
| Device Name: | EntraCare Gastrostomy Feeding Tube |
| Indications For Use: | |

The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement
gastrostomy tube in an established stoma tract for patients who cannot consume an
adequate diet orally. Gastrostomy feeding may be indicated for patients with a
functioning stomach who require long term feeding support.

(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 Devices | |
| 510(k) Number | K092418 |
| | (Per 21 CFR 801.109) |

EntraCare, LLC – Gastrostomy Feeding Tube