EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and conveys a sense of authority and purpose. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 5 2007 Ortho Development Corporation % Ms. Johanne Young Quality Systems Engineer II 12187 South Business Park Drive Draper. Utah 84020 Re: K062171 Trade/Device Name: EMF PAL II - Main Generator Unit, Irrigation Unit, and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HRX Dated: May 7, 2007 Received: May 8, 2007 Dear Ms. Young: 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. {1}------------------------------------------------ Page 2 - Ms. Johanne Young This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial cquivalence 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Wilkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Indications for Use 62171 510(k) Number (if known): _ Device Name: EMF PAL II - Main Generator Unit, Irrigation Unit, and Accessories Indications for Use The device is intended for use in general surgery. The device is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The irrigation unit; forceps and single-use extension cable are accessories to the EMF PAL If designed to be used in soft tissue surgical procedures. Refer to the instructions for Use Manuals for further information on intended surgical applications and precautions and warnings for use of the device. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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) Martin H. Melkersson (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K062171