HYS-SURGIFLATOR 150P

{0}------------------------------------------------ W.O.M. GmbH Michael McGrail, Manager, Regulatory Affairs Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany. HYS-Surgiflator 150P Proprietary Name: Hysteroscopic Insufflator Common Name: The HYS-Surgillator J.50P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700). The HYS-Surgiflator / 50P described in this notification is substantially equivelant to the Hysteroflator OP, K922632/B, manufactured by W.O.M. GmbH. The HYS-Surgiflator OP incorporates the same design features as the Hysteroflator OP K922632/B. The only differences lie in the following: - 1. The max. intrauterine pressure has been reduced from 200 mm Hg to 150 mm Hg - 2. The HYS-Surgiflator 150P allows for preselection of the desired pressure within a range of 15 - 150 mm Hg. - 3. The HYS-Surgiflator / 50P incorporates a venting valve for automatic pressure regulation, including potential reduction of overpressure. - 4. The HYS-Surgiflator / 50P incorporates an audible and visible overpressure alarm. - 5. Use of a hydrophobic filter is required by the users manual The utility and safety of hysteroscopic techniques using modern electronic hysteroscopic insufflators is thoroughly reported in the literature, including a discussion of the associated advantages and risks. - A discussion of the advantages and disadvantages of the use of CO2 gas as a distention medium during hysteroscopic procedures is presented in "Hysteroskopie", K.J. Nies, J. Hucke (1). A discussion of appropriate performance parameters for hysteroscopic insufflators as well as complications associated with hysteroscopic surgery is also included. - · A discussion of techniques, including appropriate performance parameters for hysteroscopic insufflators is provided in "Hysteroscopy: the state of the art", Hans-Joachim Lindemann, (2). - · A thorough discussion of hysteroscopy, including the history, indications, equipment and risks is provided in "Kistner's Gynecology - Principles and Practice", Kenneth Ryan, Ross Berkowitz, Robert Barbieri (3). {1}------------------------------------------------ Summary of Safety and Effectiveness - 510(k) Summary H. > W.O.M. GmbH Kaiserin-Augusta-Allee 113 D-10553 Berlin Germany. Page -2- / -2- ## REFERENCES - K.J. Nies, J. Hucke. "Hysteroskopie". Stuttgart, Georg Thieme Verlag, 1993 (Chapter IV 1. (Van Belle) and Chapter VI (G. Göretzlehrer)). - 2. Hans-Joachim Lindemann, "Hysteroscopy: the state of the art". European Journal of Obstetrics & Gynecology and Reproductive Biology 53 (1994). Pages 79-80 - Kenneth Ryan, Ross Berkowitz, Robert Barbieri. " Kistners Gynecology Principles and 3. Practice". Chicago, Year Book Medical Publishers, Inc., 1990. Pages 713 - 722 Signed: M. McDanil Michael McGrail Agent for W.O.M. GmbH 24 Sept. 1908 Date: {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle's head, represented by three curved lines. JAN 1 4 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 W.O.M. GmbH c/o Mr. Michael McGrail Regulatory Consultant 194 Branch Street Mansfield, MA 02048 Re: K983889 HYS-SURGIFLATOR 150P (CO2 Hysteroscopic Insufflator) Dated: October 27, 1998 Received: November 2, 1998 Regulatory Class: II 21 CFR 884.1700/Procode: 85 HIG Dear Mr. McGrail: 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. 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 Qualify System Requlation (QS) for Medical Devices: General requlation (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 vours, Capt. Daniel C. Schultz, M.D. 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 {3}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE APPICANT: 510(K) NUMBER (if known): DEVICE NAME: W.O.M. GmbH K983889 HYS-Surgiflator 150P INDICATIONS FOR USE: The HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) Prescription Use X (Optional Format 1-2-96) Jamil G. Seaym (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number