(144 days)
The Nutrisafe Extension Tube is intended for use with the Nutrisafe Feeding Tube, which incorporates safety luer lock hub connectors, which eliminate the risk of I.V. administration through the feeding tube. The Nutrisafe Extension Tube will allow 150 cm of additional tubing for the clinician to utilize, where necessary.
Nutrisafe® Extension Tube
This document is a 510(k) clearance letter from the FDA for a medical device called the "Nutrisafe Extension Tube." It is not a study report and therefore does not contain the information requested regarding acceptance criteria, study details, or performance metrics of a device.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices. It grants permission to market the device, subject to general controls provisions of the Act.
Therefore, I cannot provide the requested table or answer the questions based on the provided text. The document is administrative, not a scientific study report.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Vygon Corporation c/o Robert Schiff, Ph.D., RAC, CQA(ASQC) President Schiff & Company 1129 Bloomfield Avenue West Caldwell, NJ 07006
Re: K991918
NUTRISAFE® EXTENSION TUBE Dated: August 31. 1999 Received: September 1, 1999 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT
Dear Dr. Schiff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Not assigned yet ( 1 9 9 19 8
Device Name:
Nutrisafe® Extension Tube
Indications for Use:
The Nutrisafe Extension Tube is intended for use with the Nutrisafe Feeding Tube, which incorporates safety luer lock hub connectors, which eliminate the risk of I.V. administration through the feeding tube. The Nutrisafe Extension Tube will allow 150 cm of additional tubing for the clinician to utilize, where necessary.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)
Signature
Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
§ 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.