VYGON NEO-SUMP

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three heads, stacked on top of each other. The figure is black and white. The text "DEPARTMENT OF HEALTH" is written in a circular pattern around the figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 3 1998 Mr. John A. Leaity Vice President, Vygon Corp. c/o Ms. Ann Marie Cesario, R.A.C. Director, Regulatory Affairs Schiff & Company 1129 Bloomfield Avenue West Caldwell, NJ 07006 Re: K974806 Vygon Neo-Sump (Collection and aspirate measuring device) Dated: December 19, 1997 Received: December 23, 1997 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dear Mr. Leaity: 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 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 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 Regulations, 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 (OS) 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. This response to your premarket notification submission does not affect any obligation you might have under sections 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.gow/cdr/dsmaldsmam.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {1}------------------------------------------------ ## 510(k) Number (if known): Device Name: Vygon NEO-SUMP ## Indications for Use: The Vygon Neo-Sump is a collection and aspirate measuring device designed for the aspiration of the stomach contents in the newborn using wall line suction. (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) Roler R. Ratting/ (Division Sign Off) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 74806 ડી 510(k) Number.