LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

{0}------------------------------------------------ 510K Summary Stryker Spine - LITc® Dccompression System - Light Cable Traditional 510(k) Premarket Notification K122637 11222 037 2010 10 10 0 2 2 0 3 7 5 10 (k) Simmaryof Safety and Effectiveness Stryker Spine - Life® Decompression System - Light Cable NOV 1 2012 . | Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Ms. Tina Mornak<br>Regulatory Affairs Associate<br>Phone: 201-760-8193<br>Fax: 201-962-4193<br>Email: tina.mornak@stryker.com | | Date Prepared | October 25, 2012 | | Trade Name | Stryker Spine - LITe® Decompression System - Light Cable | | Proposed Class | Class II | | Classification Name<br>and Number | Light, Surgical, Fiber optic<br>21 CFR 878.4580 | | Common Name | Surgical lamp | | Product Code | FST | | Predicate Devices | NuVasive MaXcess Light Guide: K042034<br>Zimmer MIS Light: K080367 | | Device Description | The Stryker Spine LITe® Decompression System - Light Cable is a<br>single use, sterile and disposable component. The Stryker Spine LITe®<br>Decompression System - Light Cable consists of fiber optic cables<br>contained within silicone tubing which can be connected to a light<br>generator on one end and the tube of the Stryker Spine LITe®<br>Decompression System on the other end. | | Intended Use | The Stryker Spine LITe® Decompression System - Light Cable is<br>intended to provide surgical site illumination from a high intensity<br>light source when Stryker decompression tubes are in use. | | Summary of the<br>Technological<br>Characteristics | The LITe® Decompression System - Light Cable shares the same<br>technological characteristics as the predicate devices. These<br>characteristics include similar design, technical requirements, | {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle, which is a common symbol of the United States. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 NOV 1 2012 Stryker Spine % Ms. Tina Mornak Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401 Re: K122637 Trade/Device Name: Stryker LITe ® Decompression System-Light Cable Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: August 23, 2012 Received: August 29, 2012 Dear Ms. Mornak: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {2}------------------------------------------------ Page 2 - Ms. Tina Mornak forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. ### Sincerely yours, Peter D. Rumm -S 2012.11.05 10:44:24 -05'00' Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {3}------------------------------------------------ Stryker Spine - LITe® Decompression System - Light Cable Traditional 510(k) Premarket Notification Confidential # Indications for Use 510(k) Number (if known): K_12243) Device Name: Stryker LITe® Decompression System - Light Cable Indications for Use: The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use. Nilre Osle for nxm (Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices AND/OR 510(k) Number K122637 Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 2