ZIMMER MIS LIGHT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized letter "Z" inside, above the word "zimmer" in a sans-serif font. Below the word "zimmer" is the word "spine" in a smaller, different font. ## 510(k) SUMMARY Zimmer® MIS Light Image /page/0/Picture/2 description: The image shows the text "510(k) Number" followed by a handwritten number. The handwritten number appears to be "080367". The text is black and is on a white background. | Date of Summary Preparation: | February 11, 2008 | |------------------------------|--------------------------------------------------------------------| | Manufacturer: | Zimmer Spine, Inc.<br>7375 Bush Lake Road<br>Minneapolis, MN 55439 | | Company Contact: | Elsa A. Linke<br>Senior Regulatory Affairs Specialist | | Device Name: | Zimmer ^® MIS Light | | Common Name: | MIS Light | | Classification Name: | Light, Surgical, Fiber optic | | Product Code: | FST | | Regulation Number: | 21 CFR 878.4580 | | Device Classification: | Class II | | Predicate Devices: | NuVasive MaXcess Light Guide, K042034 | Description of Device: The Zimmer MiS Light consists of fiber optic cables contained within silicone tubing which can be connected on one end to a hospital provided light source and to a Zimmer surgical access instrument on the other end. Light is transmitted from the hospital light source through the cable directly to the surgical site. the Zimmer MIS Light is provided sterile for single-use only. The Light was tested for compatibility with different types of light sources ranging from 150 Watts to 300 Watts. Intended Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source. ## Comparison of Technological Characteristics: The Zimmer MIS Light shares the same technological characteristics as the predicate device. These characteristics include similar design, technical requirements, materials, and intended use. ## Substantial Equivalence: The Zimmer MIS Light is substantially equivalent to the predicate device in design, function and intended use. to 22 cm. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is composed of three curved lines, giving it a modern and abstract appearance. Public Health Service FEB 22 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Zimmer Spine, Inc. % Ms. Elsa A. Linke Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439 Re: K080367 Trade/Device Name: Zimmer® MIS Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp. Regulatory Class: II Product Code: FST Dated: February 11, 2008 Received: February 12, 2008 Dear Ms Linke: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 -- Ms. Elsa A. Linke This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N Millhusan Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use Statement 510(k) Number (if known): K080636) Device Name: Zimmer® MIS Light Indications for Use: The Zimmer MIS Light is intended to provide surgical site illumination from a high intensity light source. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) 510(k) Number Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Milburn (Division Sign-Off (Division of General, Restorative, and Neurologica K080367 Zimmer MIS Light 510(k) Submission 11-February 2008 CONFIDENTIAL