STRYKER SCOPE/INSTRUMENT HOLDER

{0}------------------------------------------------ booss 5900 Optical Court San Jose, CA 95138 t: 408 754 2491 f: 408 754 2521 www.stryker.com Stryker® **Endoscopy** ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## Device Name | Proprietary Name: | Stryker Scope Holder | |------------------------|----------------------------------------------------------------------| | Common and Usual Name: | Endoscope Holder | | Classification Name: | Laparoscope, General & Plastic Surgery, Endoscope and/or Accessories | This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA 1990. The Stryker Scope Holder is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including the Kronner Low Profile Scope Holder (K000663). The Stryker Scope Holder is a new product developed by Stryker Scope Holder is an endoscopic accessory, composed of aluminum, stainless steel, PVC and PEEK. The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures. The Stryker Scope Holder conforms to the following voluntary safety and performance standards: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety, IEC 60601-2-18 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment, IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-1-4 Collateral Standard: Programmable Electrical Medical Equipment, UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety, and EN 554 Sterilization of medical devices Validation and routine control of sterlization by moist heat. In addition, the nitrogen tank will be a DOT 39 non-refillable compressed gas tank. The nitrogen used (ID # UN1066) is an identified material on the Hazardous Materials Table in DOT 49 CFR 172.101 and will adhere to the specified shipping requirements. There are no significant technological or performance differences between the Stryker Scope Holder and the identified predicate device (Kronner Low Profile Scope Holder (K000663), nor are there any new questions raised regarding safety or effectiveness, therefore, the Stryker Scope Holder is substantially equivalent to the identified predicate devices and surgery systems. eunk cox Regulatory I ffairs Representative April 11 2006 Date: {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Stryker Endoscopy c/o Ms. Crystal Ong Regulatory Affairs Representative 5900 Optical Court San Jose, California 95138 APR 2 7 2006 Re: K060085 Trade/Device Name: Stryker Scope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 6, 2006 Received: April 12, 2006 Dear Ms. Ong: 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. Iisting 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 {2}------------------------------------------------ ## Page 2 - Ms. Kathleen Burns 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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Sor Mark N. Melkerson Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Kobco8sΓ 510(k) Number: K060085 Device Name: Stryker Scope Holder Indications for Use: The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures. Prescription Use (Per 21 CFR 801 Subpart D) OR 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) 2 (Division Sign-( ff) Division of General, M. storative, and Neurological De ... es 510(k) Number K061185 Stryker Scope Holder 510(k) Submission 3 of 12