ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY

{0}------------------------------------------------ ## K121449 JUL 2 2012 Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black shape with two white circles. The black shape appears to be two overlapping circles with a portion cut out, creating a unique design within the square. The logo is simple and professional. 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 Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92 ### 1. SUBSCRIBERS NAME & ADDRESS | Company name: | Elekta Inc. D/B/A Nucletron Corporation | |----------------------|-----------------------------------------------------------------------| | Registration number: | 1121753 | | Address: | 7 St. Paul Street, Suite 1660<br>Baltimore, Maryland 21202 | | Phone: | 770-670-2548 | | Fax: | 770-729-1585 | | Correspondent: | Thomas Valentine<br>VP QA/RA, Elekta Inc. D/B/A Nucletron Corporation | | Date: | May 1, 2012 | ## 2. MODIFIED DEVICE NAME- CLASSIFICATION: Oncentra 4.2 Trade/Proprietary Name: Common/Usual Name: Radiation Therapy Planning System Classification Name: System,Planning,Radiation Therapy Treatment 21Cfr892.5050 Class II Classification: ### 3. PREDICATE DEVICE IDENTIFICAITON Our modified device is based on the legally marketed device cited in the table below: | . Sul a se affer si for a send and and and services and super and super | 12 - Device Device - Device - Torre - Torrest -<br>Manufacturer. Ing | 1510(k) # . | |-------------------------------------------------------------------------|----------------------------------------------------------------------|--------------| | Nucletron BV | Oncentra MasterPlan 3. | K081281 | | Nucletron BV | ם<br>I ATO Brachvtherapy 14.0 | . K98334? | {1}------------------------------------------------ #### 4. OVERALL DESCRIPTION OF ONCENTRA 4.2 Oncentra 4.2 is an update of Oncentra MasterPlan 3.1- they are the same product with same technological characteristics. The technical described below is part of both Oncentra 4.2 and Oncentra MasterPlan 3.1. ### 1. Overview The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. In addition to radiotherapy, the users must be trained in general Windows usage -- Nucletron does not provide specific training or documentation conceming standard Windows functionality. The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system. #### 2. Primary Operating Functions The following table shows the general Primary Operating Functions (POF) for the system, respectively workflow descriptions and which actor that is most probably to perform the workflow. The POF have been identified in the Action Error Analysis (AEA) for Oncentra. Changes to this table must be motivated by the changes or additions to the AEA. | POF | Workflow Description | Actor | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | A. System Installation | The system (server/client) is installed or upgraded<br>to a new version. | Medical Engineers | | B. Manage Treatment Unit<br>and Physics Data | The treatment unit parameters and data are<br>installed, configured, updated and checked. | Physicists | | C. Prescription | Dose is prescribed; fractionation and treatment<br>protocol are decided. | Physicians | | D. Define anatomy | Target and risk structures are defined on the<br>planning CT images. Structures (ROI) are<br>contoured based on the information from the<br>physician. | Physicians<br>Radiation therapists<br>Physicists | | E. Approve structures | The defined structure set is approved. | Physicians | | F. Create plan | The prescription is interpreted and a treatment plan<br>developed. | Radiation therapists<br>Physicists | | G. Evaluate plan | The plan is evaluated according to the prescribed<br>dose for the contoured structures. | Physicians | | H. Approve plan | The physicians approve a plan for treatment. | Physicians | {2}------------------------------------------------ | I. Export plan | The plan is exported to the treatment unit<br>verification system | External beam:<br>Physicians<br>Brachy:<br>Radiation therapists<br>Physicists | |------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | J. Validate plan | The treatment plan is validated before treatment<br>delivery through independent calculations and<br>measurements. | Physicists | #### 3. Activities Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities". Oncentra 4.2 contains the following Activities: #### · Anatomy Module: - The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROls) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized. #### ·Beam Module The Beam Modeling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan. ## ·Plan Manager The Plan Manager activity allows the user to create a new, or modify an existing, external beam treatment plan for photon beams. The activity provides tools for manual, and, if applicable, automatic, manipulation of beam geometries and modifiers #### · Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra MasterPian system from external sources, and data output from the system to extemal sources. #### ·Dose Module The Dose Modelling (DM) module handles execution of External Beam dose calculations. #### · Optimizer Module The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM. #### · Brachy Planning Module The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. {3}------------------------------------------------ #### · Evaluation Module: The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a readonly mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM. #### · Evaluator Module The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function. #### · Volume Rendering The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module. In addition, various system utilities are available. The software runs on a Windows 7 and XP platform. ## 5. SUBSTANTIAL EQUIVALENCE The functionality for the Oncentra 4.2 is equivalent to its predicate device K081281 in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 (k) submission. ## 5.1 Dosimetric validation - Brachy The dosimetric accuracy for brachy dose calculations has for earlier releases been evaluated by the physics team. Comparisons have been made between Oncentra Brachy releases and Plato version 14.3.5. phantom measurements, and data published in the TG-43 report [[1] AAPM TG-43 Rivard MJ, Coursey BM, DeWerd LA, Hanson WF, Huq MS, Ibbott GS, Mitch MG, Nath R and Williamson JF. (2004). Update of AAPM task group no. 43 report: a revised AAPM protocol for brachytherapy dose calculations. Med. Phys. 31, pp.633-674.] The accuracy of applicator shielding calculations was validated by comparisons with the established Plato planning system No changes have been made to the brachytherapy dose calculations, therefore only a comparison with the previous version has been performed to verify consistency. The results are well within expectable error margins and the dose calculations are deemed good for clinical use. {4}------------------------------------------------ ## 5.2 Dosimetric validation - External Beam The base dose calculation algorithms of Oncentra have not been updated for this version. Comparison of results with those from earlier versions has been made to ensure that no unexpected changes have taken place. The results are well within expectable error margins and the dose calculations are deemed good for clinical use. ## 6. INTENDED USE: The legally marked predicate device Oncentra MasterPlan 3.1 (K081281) has the same intended use as the modified device cited: Oncentra 4.2 is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. ## 7. CLINICAL USAGE OF ONCENTRA 4.2 Oncentra 4.2 is to be used in radiotherapy. Most patients are cancer patients who will receive radiotherapy treatment. There are also other conditions which can be-treated with radiotherapy such as AVM Arteriovenus Malformations, Keloids (scars), and after removal of osteophytes (bone spurs) among others. - Patient population > all ages and genders. Name: John Lapre Title: Vice President Research & Development May 30, 2012 Date Title: Vice President Research & Development Nucletron B.V. Veenendaal, The Netheflands {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 > 7 2012 JUL Mr. Thomas Valentine Vice President, Quality and Regulatory Affairs Elekta Inc. D/B/A Nucletron Corporation 7 St. Paul Street, Suite 1660 BALTIMORE MD 21202 Re: K121448 Trade/Device Name: Oncentra 4.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 11, 2012 Received: May 15, 2012 ## Dear Mr. Valentine: 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 for use barba in the energeansy is toge 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 r ou may, alorested, mains of the Act include requirements for annual registration, listing of general on the profice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your dovice to to loving major regulations affecting your device can be found in Title 21, additional controls: Entraing may 10 895. 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 i teast of actised that I Dr a vise in that your device complies with other requirements of the Act that I Dri has made a actorized by other Federal agencies. You must or any 1 ouvral statuates and including, but not limited to: registration and listing (21 comply with and the rev 021 CFR Parts 801 and 809); medical device reporting (reporting of {6}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): 11121448 Device Name: Oncentra 4.2 Indications for Use: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. 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 NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | | Page 1 of ______ | |------------------------------------------------------------|----------------------------------| | | (Division Sign-Off) | | | Division of Radiological Devices | | Office of In Vitro Diagnostic Device Evaluation and Safety | | | 510K | K121448 |