ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. MAY 2 0 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Joseph E. Harms Needle & Infusion Technologies, Inc. 917 Klosterman Road, East Tarpon Springs, FL 34689 Re: K972595 Aldrete Single Shot Epidural Needle Regulatory Class: II (two) Product Code: 73 BSP Dated: February 23, 1998 February 24, 1998 Received: Dear Mr. Harms: 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. Joseph E. Harms 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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | EXHIBIT I | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known): | K972595 | | Device Name: | Aldrete Single Shot Epidural Needle | | Indications For Use: | The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia. | (FLUASE DO NOT WRITE BELOW TIMS LINE - CONTINUE ON ANOTHER PAGE IF NERIDED) ## Concurrence of CDRH, Office of Dovice Evaluation (ODE) Christy Foreman for wigs (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number: k972595 Image /page/2/Picture/6 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801.109)" in a bold, serif font. An arrow points down at the text. The text is likely part of a medical or pharmaceutical label, indicating that the product is intended for use only with a prescription. ﺘﻨ 1888 - 199 ાર Over-The-Counter Use (Optional Formal 1-2-96) 1