(78 days)
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.
Not Found
This document is a 510(k) premarket notification for a medical device called the "EntraCare Gastrostomy Feeding Tube." It's a regulatory approval document from the FDA, not a study report or technical specification outlining acceptance criteria and performance data for a device.
Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.
This document primarily states:
- The device name: EntraCare Gastrostomy Feeding Tube
- Its intended use: as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally, and who have a functioning stomach requiring long-term feeding support.
- That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
To provide the requested details, a different type of document, such as a validation study report, clinical trial results, or a technical design specification with performance data, would be needed.
{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 (800) 638-2041 or (301) 796-7100 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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.