TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20

{0}------------------------------------------------ G 4/2/99 Premarket Notification Nucletron mlcroSelectron-HDR classic with TCS Date : 31 August, 1998 Image /page/0/Picture/5 description: The image shows the word "Nucletron" in bold, black font, next to a square logo. The logo contains a black circle with two white circles on either side, all within a black square border. The word "Nucletron" is positioned to the right of the logo. K983115 NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485 Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section PKG MKT mHDR 510k # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c) #### Submitter of 510(k) a. Company name: Registration # Address: Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133 Contact Person: Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone: Fax: 410-312-4197 #### b. Device Name: | Trade/Proprietary Name: | Treatment Control Station - microSelectron-HDR classic<br>Upgrade, Remote Afterloading System | |-------------------------|-----------------------------------------------------------------------------------------------| | Classification Name: | Remote Control Radionuclide Applicator System | | | 21 CFR 892.5700 Class II. | #### Legally Marketed Predicate Device(s) C. Our Device is substantially equivalent to the legally marketed prodicate devices cited in the table below. Appendix 5, page 2 {1}------------------------------------------------ G Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998 | Manufacturer | Device | 510(k) # | |--------------|----------------------------|----------| | Nucletron | microSelectron-HDR classic | K864210 | | Nucletron | microSelectron-HDR | K953946 | #### DescriptIon d. The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic. The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators. The TCS user obtains authorization for parts of the functionality depending on the user name and password. Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prlor and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated. A detailed description including principles of operation and other information necessary to understand the device is provided in Section 3. #### Intended use e. The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are: Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments. #### Summary of technological considerations f. The Treatment Control Station - microSelectron-HDR classic Upgrade Is substantially equivalent to the predicate devices. It allows the use of an enhanced user interface to program a treatment and monitor a treatment in progress. g 31-08-98 Date Name: P.Krechting Title Product Manager Nucletron bv Veenendaal Netherlands Appendix 5, page 3 {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 1995 Ralph E. Shuping, Sc.D. Regulatory Affairs Manger Nucletron Corporation 7080 Columbia Gateway Drive Columbia, Maryland 21046 Re: K983115 Treatment Control Station (TCS) MicroSelectron HDR Classic Upgrade Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 892.5700/Procode: 90 JAQ Dear Dr. Schuping: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controis 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, CART Daniel O. Schultz, M.D. CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ G Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998 Image /page/3/Picture/4 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black shape with two white circles inside. Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section nucletron B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax PKG MKT mHDR 510k ## Statement of intended use Device Name: Treatment Control Station - microSelectron-HDR classic Upgrade, remote afterloading system ### Intended use The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are: Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments. ### Prescription use The Treatment Control Station - microSelectron-HDR classic Upgrade is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional. Name P. Krechting 31-08-98 Date Title Product Manager Nucletron BV Veenendaal Netherlands David b. Stypman Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological 510(k) Number Appendix 5, page 4