AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES

{0}------------------------------------------------ MAR 5 2002 KD/4081 Page 1 of 2 ## Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act May 1, 2001 #### General Provisions 1. Trade Name: Radiation Therapy Wedges Beam Modifier, Wedges Common Name: Applicant Name and Address: AKTINA Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865 #### 2. Name of Predicate Devices Mevatron KD-2, Siemens Medical Labs, Inc., K862339 Clinac 1800, Varian Associates, Inc., K832503 1 Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977). #### 3. Classification This device is classified as a class II device according to 21 CFR 892.5770. #### 4. Performance Standards The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product. {1}------------------------------------------------ K014081 Page 2 of 2 #### ડ. Intended Use and Device Description The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams. #### Biocompatibility 6. This product raises no issues of biocompatibility. #### 7. Summary of Substantial Equivalence This device is similar in design and intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 5 2002 Ms. Joan Zacharopoulos Vice President AKTINA Medical Physics Corp. 360 North Route 9W CONGERS NY 10920 Re: K014081 Received: December 11, 2001 Trade/Device Name: AKTINA Medical Physics Corporation Radiation Therapy Wedges Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: November 1, 2001 Dear Ms. Zacharopoulos: 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 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Dri Imaling of succion 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 II you desire specific acries at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and 1-6639. Also, please note the regulation entitled, "Misbranding Other of Compilance as (2001) cation" (21 CFR Part 807.97). Other general information on by reserved to promazive nearchard from the Division of Small Manufacturers, your responsibilities 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, 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 {4}------------------------------------------------ ### Indications for Use K014081 ### 510(k) Number: Device Name: Radiation Therapy Wedges ### Indications for Use: In radiation therapy, it is often desirable to modify the intensity or penetrating depth of a treatment beam so as to minimize radiation exposure to normal tissue. Many devices have and are used for this function including but not limited to partial beam blocks, tissue compensating filters, the most commonly, the wedge. This physical device is constructed of high-density materials that the most commonly, the weage. The payed block, differentially attenuate the transmitted radiation beam. When mabilities a weegs that is transmitted through the wedge will have a sloped intensity at The resulting radiation boan that is an un-attenuated beam, which is uniform and consistent in intensity across the beam at the patient's surface. These wedges are designed for use only as a intensity across are boaith photon beams in Radiation Therapy external beam treatments. David A. Szymon Abdominal. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: Or V Over-The Counter Use: (Per 21 CFR 801.109)