GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES

{0}------------------------------------------------ # 1971781 ## 510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES NOV 2 1 1997 | Submitter Name: | Greatbatch Scientific<br>a division of Wilson Greatbatch Ltd. | |---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 4100 Barton Road<br>Clarence, New York 14031 | | Contact Person: | Gary J. Sfeir, RAC | | Phone Number: | 716.759.5277 | | Facsimile Number: | 716.759.5280 | | Date Prepared: | 30 October, 1997 | | Device Trade Name: | Greatbatch Scientific MR Compatible Arthroscopes and Small Joint<br>Arthroscopes | | Device Common Name: | Arthroscope | | Classification Name: | Arthroscope | | Predicate Devices: | Optus Arthroscopes and Mini Arthroscopes | | Device Description: | The Greatbatch Scientific MR Compatible Arthroscopes and Small<br>Joint Arthroscopes are available in standard and autoclavable 1.7mm,<br>2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles. | | Intended Use: | For use by practitioners to treat the small joints of the wrist, knee,<br>ankles, elbow, shoulder, and the temporal-mandibular joint in patients<br>in a MR or an interventional MR environment, not to exceed a 1.5<br>Tesla static magnetic field. | | Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Devices(s): | The device technological characteristics are similar in design to the<br>predicate device. | | Performance Data: | The device was tested for MR Compatibility and was found to be<br>acceptable for use in a 1.5 Tesla static magnet field. See attached MR<br>Safety Testing summary. | | Conclusion: | The Greatbatch Scientific MR Compatible Arthroscopes, Small Joint<br>Arthroscopes, and the Accessories as designed, can be used in a MR or<br>an interventional MR environment, not to exceed a 1.5 Tesla static<br>magnetic field. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an inner symbol. The inner symbol features a stylized eagle or bird-like figure, with its wings forming a protective shape. The text is arranged around the top and left side of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### NOV 21 1997 Mr. Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence, New York 14031 Re: K971781 > Trade Name: Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes --- . . . . . . . . . . . . - Regulatory Class: II Product Code: HRX Dated: September 5, 1997 Received: September 8, 1997 Dear Mr. Sfeir: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indieations 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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. {2}------------------------------------------------ Page 2 - Mr. Gary J. Sfeir, RAC This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### SECTION 4 #### INDICATIONS FOR USE 510 (k) Number (if known): 97i781 Device Name: Greatbatch Scientific MR Compatible Arthroscopes and Small_Joint Arthroscopes and Accessories Indications For Use: The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE) | PRESCRIPTION USE | <div style="text-align:center;">X</div> | OR... | OVER-THE-COUNTER USE | |------------------|-----------------------------------------|-------|----------------------| |------------------|-----------------------------------------|-------|----------------------| (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | 1497178/ | |---------------|----------| |---------------|----------|