ACCULOC BREAST LOCALIZATION SYSTEM

{0}------------------------------------------------ Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Lee Myers, M.D. Director of Operations Northwest Medical Physics Equipment, Inc. 21031 67th Ave W LYNNWOOD WA 98036 DEC 1 2 2006 Re: K063274 Trade/Device Name: ACCULOC Breast Localization System (formerly MAMMOLOC) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 26, 2006 Received: October 30, 2006 Dear Dr. Myers: 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/0/Picture/9 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "PA" are in the center of the seal in a bold font. The word "Centennial" is below the letters "PA". Three stars are at the bottom of the seal. Protecting and Promoting Public Health {1}------------------------------------------------ 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. 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 one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | 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/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Section 4. Indications for Use Statement 510 (k) Number (if known): (new product) Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast. The software is used to determine the precise location of the target with respect to implanted fiducials. Prescription Use Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) AMD/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Sezerman (Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Page I of I (Posted November 13, 2003)