GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE

{0}------------------------------------------------ MAY 1 3 1998 ## 510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTERC - Greatbatch Scientific Name: Submitter Division of Wilson Greatbatch Ltd. 4100 Barton Road Address: Submitter Clarence, New York 14031 Gary J. Sfeir, RAC Person: Contact 716.759.5277 Phone Number: Facsimile Number: 716.759.5280 29 August, 1997 Prepared: Date Greatbatch Scientific MR Compatible Hysteroscope Trade Name: Device Device Common Name: Hysteroscopes Hysteroscopes Classification Name: Optus, Inc. Hysteroscopes and Accessories Predicate Devices: The Greatbatch Scientific MR Compatible Device Description: Hysteroscopes are available in standard and autoclavable 2.0mm and 4.0mm outer diameters with 0° and 30° viewing angles, Used to permit direct viewing of the cervical canal Intended Use: and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Device Technological The device technological characteristics are similar Characteristics in design to that of the predicate device. and Comparison to Predicate Devices(s): The device was tested for MR Compatibility and was Performance Data: found to be acceptable for use in a shielded 1.5 Tesla magnet. Conclusion: The Greatbatch Scientific MR Compatible Hysteroscope as designed can be used in a MR or an interventional MR environment not to exceed a shielded 1.5 Tesla magnet. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized image of an eagle, which is a common symbol of the United States. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Re: K971374 Greatbatch Scientific MR Compatible Hysteroscope Dated: April 16, 1998 Received: April 17, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH Dear Mr. Sfeir: 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 OS 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 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/cdrl/dsmaldsmamain.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproductive Director. Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure MAY 1 3 1998 Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence, NY 14031 {2}------------------------------------------------ ## SECTION 4 ## INDICATIONS FOR USE (k) Number (if known): 510 K971374 Device Name: Greatbatch Scientific MR_ Compatible Hysteroscope Indications For Use: The Greatbatch Scientific MR Compatible Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE) | PRESCRIPTION USE | <div>✓</div> | OR... | OVER-THE-COUNTER USE | |------------------|--------------|-------|----------------------| |------------------|--------------|-------|----------------------| | (Division Sign-Off) | (OPTIONAL FORMAT 1-2-96) | |--------------------------------------------------------------------|--------------------------| | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K971374 |