ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font. The logo is in white against a black background. ## No. 22 83 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K49354D This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge. | Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>(310) 558-1500 | |------------------------|---------------------------------------------------------------------------------------------------------------| | Contact: | Kevin Kennan<br>Regulatory Affairs Specialist | | Device Identification: | Common Name:<br>Arthroscope | | | Trade Name: (optional)<br>Karl Storz ENDOSPINE Operating Tube and Telescope Bridge | Indication: The KSEA ENDOSPINE Operating Tube and Telescope Bridge is designed to be used by qualified surgeons and physicians for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures. Device Description: The KSEA ENDOSPINE Operating Tube and Telescope Bridge consists of an operating tube, an obturator for use with the operating tube, and a telescope bridge for use with the operating tube. The telescope bridge contains a working channel, an irrigation channel, and a channel for an endoscope. The body contact portions of the KSEA ENDOSPINE Operating Tube and Telescope Bridge are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use. Substantial Equivalence: The KSEA ENDOSPINE Operating Tube and Telescope Bridge is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA ENDOSPINE Operating Tube and Telescope Bridge and the predicate device raises no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices. Signed: Kevin Kennan Senior Regulatory Affairs Specialist {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850 NOV 22 1999 Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230 Re: K993540 Trade Name: ENDOSPINE Operating Tube and Telescope Bridge Regulatory Class: II Product Code: HRX Dated: October 11, 1999 Received: October 19, 1999 Dear Mr. Kennan: 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. Kevin Kennan 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 vours. Stipt Rhodes James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with a target symbol in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. ## K99354D 510(k) Number (if known): Device Name: ENDOSPINE Operating Tube and Telescope Bridge Indications for Use: This instrument is indicated for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <img alt="Signature" src="signature.jpg"/> | |-----------------------------------------|--------------------------------------------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K993540 | | Prescription Use: | X | OR Over-The-Counter Use: | | |----------------------|---|--------------------------|--| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |