AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR

{0}------------------------------------------------ ## BEI MEDICAL SYSTEMS MED SYSTEM Image /page/0/Picture/1 description: The image shows an address. The address is "83 Hobart Street, Hackensack, NJ 07601". The text is black and the background is white. Tel 201.489.4222 Fax 201.489.6745 K971492 Plol ## - 5 1997 ## PREMARKET NOTIFICATION [510(K)] SUMMARY - BEI Medical Systems Company, Inc. l. Submitter: 83 Hobart Street Hackensack, New Jersey 07601 (201) 489-4222 (phone) (201) 489-6745 (fax) Lorraine T. Montemurro, RN 11. Contact Person: Director, Regulatory Affairs & Quality Assurance April 24, 1997 III. Date: IV. Device Name: Automatic Electronic Hysteroscopic Insufflator - AEH-200 Hysteroscopic Insufflator V. Common Name: Hysteroscopic Insufflator (per 21 CFR section 884.1700) VI. Classification Name: Hamou Microhysteroflator - Karl Storz VII. Equivalent Device: Hystero-Insufflator Electronic - Wisap This device is intended to distend the uterus by filling the uterine VIII. Device Description: cavity with gas to facilitate viewing with a hysteroscope. The AEH-200 is intended to distend the uterus by filling the uterine IX. Intended Use: cavity with CO2 gas to facilitate viewing with a hysteroscope. ×. This device has demonstrated compliance with the recommendations Technological Summary: in the Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators. Specifically Sections II B through II F. XI. Nonclinical Performance: In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters. Conclusion: XII. This device has proved comparable to similar devices already available and has not demonstrated any safety issues. Image /page/0/Picture/7 description: The image shows a circled letter R. The letter R is in a sans-serif font. The circle around the letter R is slightly distressed, giving it a vintage or worn appearance. The image is in black and white. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of four abstract shapes that resemble human figures or stylized wings, arranged in a vertical stack. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 1997 Re: K971492 Ms. Lorraine Montemurro Director, Regulatory Affairs & Quality Assurance BEI Medical System Co., Inc. 83 Hobart Street __ _ _ _ _ _ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hackensack, New Jersey 07601 Automatic Electronic Hysteroscopic Insufflator (AEH-200) Dated: July 31, 1997 ... . Received: August 1, 1997 Regulatory class: II 21 CFR §887.1700/Product code: 85 HIG Dear Ms. Montemurro: 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 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 misbranion. 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure 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 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/dsmamain.html". Sincerely yours. W. Hiau Yu 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 {2}------------------------------------------------ BEI MEDICAL SYSTEMS 83 Hobart Street Hackensack, NJ 07601 Image /page/2/Picture/3 description: The image shows a logo with a black triangle pointing downwards at the top. Below the triangle, there are two lines of text. The first line reads "MEDICAL" and the second line reads "SYSTEMS". The text is in a sans-serif font and is centered below the triangle. 510(k) Number (if known): _ New Device Name: Automatic Electronic Hysteroscopic Insufflator Indications For Use: This device is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Roter R. Sitting/ Division of OM (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K971492 Prescription Use ___ (Per 21 CFR 801.109) OR Over-The-Counter Use _ Image /page/2/Picture/15 description: The image shows a logo with the letters 'R' and 'L' inside a circle. The letter 'R' is larger and positioned slightly above the letter 'L'. The circle is not a solid line but appears to be made of small dots or dashes, giving it a textured or slightly distressed look. The logo has a simple, classic design and is presented in black and white.