(136 days)
The AMT Transgastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
Not Found
The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Applied Medical Technology, Inc., regarding their "AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit."
The letter acknowledges receipt of their submission, informs them that the device has been determined to be substantially equivalent to a legally marketed predicate device, and outlines regulatory responsibilities. It also states the indications for use and contraindications for the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them based on the provided input.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2013
Applied Medical Technology, Inc. % Mr. Grant W. Phillips Engineer 8000 Katherine Boulevard BRECKSVILLE OH 44141
- Re: K123716
Trade/Device Name: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 28, 2013 Received: April 1, 2013
Dear Mr. Phillips:
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. 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. 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
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Page 2 - Mr. Grant W. Phillips
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 (reporting of medical device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION - 4
c. - INDICATIONS FOR USE STATEMENT
Traditional 510(k) Number (if known): Original 510(k) Number: K110804
Trade Name: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit Common Name: Gastroenterology Device (GJ-Tube)
Indications For Use:
The AMT Transgastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
Contraindications:
Contraindications for placement of a transgastric-jejunal feeding tube include, but are not limited to ascites, colonic interposition, portal hypertension, peritonitis and morbid obesity.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE) Benjamin Rafisher 2013.04119 16:36:24 -04'00
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Applied Medical Technology, Inc. - 510(k) Submission AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit Section 4 - Page 4.2
§ 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.