RADIANCE V2

{0}------------------------------------------------ Premarket Notification: Traditional 510(k) ## 510(k) Summary JAN 3 1 2014 | Submitter Name:<br>Submitter Address: | GMV Soluciones Globales Internet S.A.U.<br>Isaac Newton. 11; PTM Tres Cantos<br>Madrid 28760<br>Spain | | | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--| | Phone Number:<br>Fax Number: | 011 34 91 807 22 70<br>011 34 91 807 21 99 | | | | Contact Person: | Carlos Illana Alejandro | | | | Date Prepared: | 14 November 2013 | | | | Device Trade Name: | Radiance V2 | | | | Common Name | Radiation Treatment Planning Software | | | | Classification Name.<br>Number &<br>Product Code: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050<br>MUJ | | | | Predicate Devices: | K112060 | Radiance<br>cleared 01/06/2012 | | | | K121653 | INTRABEAM SYSTEM WITH INTRABEAM<br>SPHERICAL APPLICATORS<br>Cleared 12/27/2012 | | | | K102011 | Eclipse Treatment Planning System<br>Cleared 09/03/2010 | | | Device Description<br>and Statement of<br>Intended Use | Radiance V2 is a treatment planning system, that is, a software<br>program for planning and analysis of radiation therapy plans.<br>Typically, a treatment plan is created by importing patient images<br>obtained from a CT scanner, defining regions of interest either<br>manually or semi-automatically, deciding on a treatment setup and<br>objectives, optimizing the treatment parameters, comparing<br>alternative plans to find the best compromise, computing the<br>clinical dose distribution. approving the plan and exporting it. | | | {1}------------------------------------------------ Statement of Intended Use: Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval bv the intended user. The system functionality can be configured hased on user needs. The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system. The technological characteristics are essentially the same as those Summary of Technological Characteristics of the predicate. All devices produce treatment plans with corresponding dose distributions computed using a three dimensional dosimetry engine. All devices have a function of electronic approval of treatment plans by trained and authorized staff, and export in DICOM format for commencing treatment or archiving. From the standpoint of both functionality and workflow the Radiance V2 device is substantially equivalent to the identified predicates as follows: - · Within Radiance V2 and its predicates. Radiance and Eclipse. the user can adjust parameters to achieve a predicted outcome. rather than make a decision intra-operatively. - · Radiance V2 and its predicates Radiance and Eclipse are designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with malignancies. - · Radiance V2 and its predicates Radiance and Eclipse provide treatment plans with estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. - · Radiance V2 and its predicates Radiance and Eclipse use externally acquired medical images and user input to achieve the result. The Radiance V2 dose distribution computation algorithm for the X-rav source of INTRA BEAM is equivalent to provided computation within INTRABEAM radiation treatment device Substantial Equivalence Section 5.0 {2}------------------------------------------------ | | itself.<br>The added functionality of Radiance V2 versus Radiance is<br>substantial equivalent to other marketed predicate devices and<br>therefore there are no extra concerns on safety and efficacy of the<br>proposed Radiance V2 device with respect to its predicates. | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Non Clinical Data | Validation and Verification Testing carried out on the Radiance<br>V2 indicates that it meets its predefined products requirements and<br>requirements from the following product standards:<br>• IEC 61217 Radiotherapy equipment - Coordinates,<br>movements and scales<br>• IEC 62083 Medical electrical equipment - Requirements<br>for the safety of radiotherapy treatment planning systems | | Clinical Data | The predecessor of Radiance V2 system, i.e., Radiance, has been<br>tested clinically. This Clinical Study evaluated the effectiveness<br>and repeatability of the planning process in IORT with Radiance<br>in regard to the current modalities and the current uncertainties in<br>regard to (manual) treatment planning. The changes in Radiance<br>V2 (computation algorithms and beam modeling tool) do not<br>modify basic functionality/workflow in which that study was<br>performed. Therefore the Clinical Study conducted for Radiance<br>and data collected can be safely extrapolated and is also valid for<br>Radiance V2, moreover all new design features have been<br>successfully validated ex-clinic. | | Conclusion | The information discussed above demonstrates that the Radiance<br>V2 device is substantially equivalent to the predicate device. | | Declarations | • This summary includes only information that is also covered in<br>the body of the 510(k).<br>• This summary does not contain any puffery or unsubstantiated<br>labeling claims.<br>• This summary does not contain any raw data, i.e., contains only<br>summary data.<br>• This summary does not contain any trade secret or confidential<br>commercial information.<br>• This summary does not contain any patient identification<br>information. | . : {3}------------------------------------------------ | Summary of Technical Characteristics | | | | | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Feature | Device Radiance<br>V2 | Radiance | Eclipse | INTRABEAM<br>System with<br>INTRABEAM<br>Spherical<br>Applicators | | 510(k)<br>Number | | K112060 | K102011 | K121653 | | Manufacturer | GMV Soluciones<br>Globales Internet<br>S.A.U. | GMV Aerospace<br>and Defence S.A. | Varian Medical<br>Systems, Inc. | Carl Zeiss<br>Meditec AG | | Classification<br># & Product<br>Code | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5900<br>JAD | | Indication for<br>use | Radiance V2 is a<br>software system<br>intended for<br>treatment<br>planning and<br>analysis of<br>intraoperative<br>radiation therapy<br>administered<br>with devices<br>suitable for<br>intraoperative<br>radiotherapy.<br>The treatment<br>plans provide<br>treatment unit<br>set-up parameters<br>and estimates of<br>dose distributions<br>expected during<br>the proposed<br>treatment, and<br>may be used to<br>administer<br>treatments after<br>review and<br>approval by the<br>intended user.<br>The system<br>functionality can | Radiance is a<br>software system<br>intended for<br>treatment<br>planning and<br>analysis of<br>intraoperative<br>radiation therapy<br>by means of<br>electron beams.<br>The treatment<br>plans provide<br>treatment unit<br>set-up parameters<br>and estimates of<br>dose distributions<br>expected during<br>the proposed<br>treatment, and<br>may be used to<br>administer<br>treatments after<br>review and<br>approval by the<br>intended user.<br>The system<br>functionality can<br>be configured<br>based on user<br>needs. | The Eclipse<br>Treatment<br>Planning System<br>(Eclipse TPS) is<br>used to plan<br>radiotherapy<br>treatments for<br>patients with<br>malignant or<br>benign diseases.<br>Eclipse TPS is<br>used to plan<br>external beam<br>irradiation with<br>photon, electron<br>and proton<br>beams, as well as<br>for internal<br>irradiation<br>(brachytherapy)<br>treatments. In<br>addition, the<br>Eclipse Proton<br>Eye algorithm is<br>specifically<br>indicated for<br>planning proton<br>treatment of<br>neoplasms of the<br>eye. | The<br>INTRABEAM<br>System is<br>intended to be<br>used for radiation<br>therapy<br>treatment. | | | be configured<br>based on user<br>needs.<br>The intended<br>users of Radiance<br>V2 shall be<br>clinically<br>qualified<br>radiation therapy<br>staff trained in<br>using the system. | The intended<br>users of Radiance<br>shall be clinically<br>qualified<br>radiation therapy<br>staff trained in<br>using the system. | | | | System<br>Design | Software only | Software only | Software only | Hardware and<br>Software | | Calculation<br>for electrons | Dose<br>distributions<br>computed using a<br>three dimensional<br>dose engine.<br>Pencil Beam<br>computation and<br>Monte Carlo<br>Computation for<br>electrons | Dose<br>distributions<br>computed using a<br>three dimensional<br>dose engine.<br>Pencil Beam<br>Computation | Same for<br>electrons<br>i.e. Pencil Beam<br>computations and<br>Monte Carlo<br>Computation for<br>electrons | Not applicable<br>(X-ray device) | | Calculation<br>for photons | Dose Painting<br>(Planning<br>calculation<br>interpolation of<br>PDD<br>measurements) | Not applicable | Not applicable | Calibration files<br>for<br>INTRABEAM:<br>PDD scaled with<br>the dose rate<br>factor for MU<br>computation of<br>photons | | Input | Externally<br>acquired patient<br>medical images<br>and user input.<br>Calibration files<br>for<br>INTRABEAM. | Same | Same | Calibration files<br>for<br>INTRABEAM:<br>MU/Gy factor +<br>additional factors | | Output | Treatment plans<br>with | Same for<br>electrons | Same for<br>electrons | Monitor units | | | corresponding<br>dose distributions | | | | | Plan review<br>and approval | Allows electronic<br>approval of<br>treatment plans<br>by trained and<br>authorized staff | Same | Same | None | | Dose<br>calculation<br>algorithm<br>confirmation | Algorithms<br>confirmed for a<br>wide variety of<br>field geometries,<br>treatment units,<br>treatment setups<br>and patient<br>positions,<br>including<br>different dose<br>grid resolution<br>settings. | Same for<br>electrons | Same for<br>electrons | Same for MU<br>computation | | Beam<br>modeling tool | Beam modeling<br>of the treatment<br>unit based on<br>relative<br>measurements<br>and output<br>factors | None | Same | Not applicable | : . {4}------------------------------------------------ Premarket Notification: Traditional 510(k) Section 5 Page 6 of 7 {5}------------------------------------------------ K.133655 page 6of6 V2 Radiance V2 Premarket Notification: Traditional 510(k) . {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in a simple, abstract design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 31, 2014 GMV Soluciones Globales Internet S.A.U. % Ms. Debra Ferland Official Correspondent for GMV Oserve Group P.O. Box 940 CHARLESTOWN NH 03603 Re: K133655 Trade/Device Name: Radiance V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 25, 2013 Received: December 4, 2013 Dear Ms. Ferland: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {7}------------------------------------------------ Page 2-Ms. Ferland If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/RcportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours,  for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K133655 Device Name: Radiance V2 Indications For Use: Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system. Prescription Use (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 Center for Devices and Radiological Health (CDRH) Sm.7) Page 1 of 1 (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k). K133655