INTRABEAM SYSTEM

{0}------------------------------------------------ KOSIOSI # 510(k) Summary Carl Zeiss Surgical GmbH INTRABEAM® System MAY 2 3 2005 #### 1. SPONSOR Carl Zeiss Surgical GmbH Carl Zeiss Strasse 4-54 D-73446 Oberkochen Germany | Contact Person: | Michael Haisch, Director, Quality Management | |-----------------|----------------------------------------------| | Telephone: | +49-7364-20-2555 | April 20, 2005 Date Prepared: ## 2. DEVICE NAME | Proprietary Name: | INTRABEAM® System | |----------------------|-------------------------------------------------| | Common/Usual Name: | X-Ray Radiation Therapy Control Unit | | Classification Name: | X-ray Radiation Therapy Systems and Accessories | ## 3. PREDICATE DEVICES PRS400 System (K980526 and K992577) ## 4. DEVICE DESCRIPTION The INTRABEAM® System described in this Special 510(k) is a modification and enhancement of the PRS400 System cleared under K980526 and K992577. The INTRABEAM® System consists of the PRS500 Control Console, the XRS 4, the Workstation Software, the User Terminal, the verification accessories, and the treatment accessories. The PRS500 Control Console provides all low-level operational control and safety functions of this System. The User Terminal with Workstation Software is the primary interface between the System and the user. The Software provides the high level control and display functions of the System. With the INTRABEAM® System, the radiologist, physicist, or technologist uses the Workstation Software on the User Terminal to set up the PRS500 Control Console (perform the pre-treatment verification and treatment planning), perform the treatment to completion, log all procedure variables and events, and after completion of the treatment, save and/or print treatment and performance data. {1}------------------------------------------------ ## 5. INTENDED USE The INTRABEAM® System is intended to be used for radiation therapy treatment. ## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6. تم ﻬﺎ ﺗ Equivalence of the INTRABEAM® System with the PRS 400 System is based on intended use, indications for use, technological characteristics, system specifications, and operational characteristics. ## 7. TESTING The INTRABEAM® System was systematically tested to demonstrate that the modifications did not adversely affect safety and effectiveness. Testing described in this premarket notification included functionality (integration testing of hardware, firmware, and accessories), safety, electrical safety, electromagnetic compatibility, environmental testing, mechanical stress testing, and validation testing. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is facing left and has three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following the curve of the logo. The text is in a sans-serif font and is relatively small compared to the size of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Carl Zeiss Surgical GmbH c/o Rosina Robinson, RN, MEd, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 MAY 2 3 2005 Re: K051055 R031055 Trade/Device Name: Carl Zeiss Surgical GmbH INTRABEAM® System Regulation Number: 21 CFR §892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: April 25, 2005 Received: April 26, 2005 Dear Ms. Robinson: 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 lave 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 do not require apperal 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 Aporaval), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, it ifaly 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 I reaso or arrison 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 I cacial states and regaring, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modialing practice requirements as set forth in the quality systems (QS) (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 Section 5 10(k) The status and the first of the success of your device to Ilegal This letter will allow you to begin harketing your aver equivalence of your device to a legally premarket notification. The FDA Inding of saosantal equil and this, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased on the regulation rumber If you desire spectic advice for your device on our laboring agains of ( 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "virsonants of your responsibilities under the Act from the 807.97). You may obtain other general information on your of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hodgdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K051055 Device Name: Carl Zeiss Surgical GmbH INTRABEAM® System Indications for Use: The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel A. Lyon (Division Sign-Off) (Division Sign-On) Division of Reproductive, Abdominal in a mical Devices