MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400

{0}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS MICRO MEDICAL DEVICES, INC. MICRO ENDOSCOPE The Summary of Safety and Effectiveness on Micro Endoscope reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth. ## Intended Use Micro Arthroscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints in conjunction with cameras. ### Caution Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. #### Contraindication Bending or prying with scope will damage optics. #### Precautions - Surgical laser and mechanical cutting instruments can damage the scope. ● - Do not allow the arthroscope tip to come into contact with hard or sharp objects. . - Use this device only with a xenon light source (maximum 300 watts) and Micro Medical . Devices, Inc camera. #### Substantial Equivalency Information The Micro Arthroscope is similar to the Galileo Arthroscope currently offered by Galileo Electro-Optics Corporation. | Materials | Galileo<br>Stainless Steel | Micro Medical<br>Stainless Steel<br>Polyimide | |---------------|----------------------------|-----------------------------------------------| | Sterilization | Reusable: EO and<br>Steris | Single Use: EO<br>SAL 10-6 | The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Micro Medical Endoscope is comparable to that of the Galileo Electro-Optics Corporation Arthroscope {1}------------------------------------------------ Image /page/1/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 5 1999 Mr. Jim Ohneck General Manger Micro Medical Devices, Inc. 11000 Cedar Avenue Suite 445 Cleveland, Ohio 44106 Re: K983882 Trade Name: Micro Endoscope Regulatory Class: II Product Code: HXR Dated: February 3, 1999 Received: February 5, 1999 Dear Mr. Ohneck: 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 requirement, 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. {2}------------------------------------------------ Page 2 - Mr. Jim Ohneck 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) 594-4595. 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, 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}------------------------------------------------ 510(k) Number (if known):_ Micro Endoscope 983882 Devicc Namc:_______ Indications For Use: Micro Endoscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints of the wrists, ankles, elbows, knees, or shoulders in conjunction with cameras. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. CONTRAINDICATIONS: Bending or prying with scope will damage optics. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) - | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K983882 | Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)