ULTRANEB

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Bremed Italia, S.R.L. c/o Mr. Mark Hebensteit Consultant 1337 Rockwood Forest Drive Arnold, MO 63010 FEB 18 1998 Re: K974379 ULTRANEB Regulatory Class: II (Two) Product Code: 73 CAF Dated: October 24, 1997 Received: November 20, 1997 Dear Mr. Hebenstreit: 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 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 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 (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. {1} Page 2 - Mr. Mark Hebenstreit 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) 594-4648. 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/dsmamain.html." Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} # INDICATIONS FOR USE STATEMENT 510(k) Number: Pending K474379 Device Name: ULTRANEB ULTRASONIC Indications for Use: This product is an ultrasonic nebulizer that is used to provide aerosolized broncho dialator medication to persons with asthma and emphysema. The device creates aerosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the tubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders. This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices. The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe. The components found within this product are common items. The product consists of a thermally protected, simplistic circuit board, a piezoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use XXXXX OR Over-The-Counter (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K474379