RayStation 12A

{0}------------------------------------------------ March 29, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. RaySearch Laboratories AB (publ) % David Hedfors Quality and Regulatory Affairs Director Eugeniavagen 18 Stockholm, 113 68 SWEDEN Re: K222312 Trade/Device Name: RayStation 12A Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: July 26, 2022 Received: August 1, 2022 Dear David Hedfors: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows the name "Lora D. Weidner" in a large, sans-serif font. The name is stacked vertically, with "Lora D." on the top line and "Weidner" on the bottom line. The text is black against a white background. Digitally signed by Lora D. Weidner -S Date: 2023.03.29 10:20:55 -04'00' Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222312 Device Name RayStation 12A ### Indications for Use (Describe) RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary 1. #### 1.1 510(k) owner RaySearch Laboratories AB (publ) Eugeniavägen 18 113 68 Stockholm Sweden Tel: +46 8 510 530 00 #### 1.2 Contact person David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: quality@raysearchlabs.com +46 722 366 110 Tel: #### 1.3 Preparation date March 28th, 2023. #### 1.4 Trade name The trade name is RayStation. The marketing name is RayStation 12A and RayPlan 12A. #### 1.5 Common name Radiation therapy treatment planning system #### 1.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) #### 1.7 Predicate device K220141 RayStation 11B #### 1.8 Device description RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. The device lets the user import patient images and data, identify treatment targets and organs at risk, create an optimal treatment plan taking into account patient anatomy, prescribe treatment dose and organ at risk sensitivity, review and approve the plan and then administer the treatment. A scientific basis for the device is the implementation of peer reviewed algorithms of plan parameter optimization and photon and particle dose calculation. RayStation consists of multiple applications: - . The main RayStation application is used for treatment planning. - The RayPhysics application is used for commissioning of treatment machines to make ● them available for treatment planning and used for commissioning of imaging systems. - The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments. These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data. The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan has a limited set of modules, indicated in the following table. {4}------------------------------------------------ | Planning activity | Module | Available in<br>RayPlan | |-------------------------|------------------------------|-------------------------| | Automated planning | Plan explorer | No | | Automated planning | Automated breast planning | No | | Automated planning | Fallback planning | No | | Automated planning | Fallback protocol management | No | | Patient data management | Patient data management | Yes | | Patient modeling | Image registration | Yes | | Patient modeling | Structure definition | Yes | | Patient modeling | Deformable registration | No | | Patient modeling | Eye modeling | No | | Plan design | Virtual simulation | Yes | | Plan design | Plan setup | Yes | | Plan design | 3D-CRT beam design | Yes | | Plan design | Electron beam design | Yes | | Plan design | Proton beam design | No | | Plan design | Brachy planning | Yes | | Plan optimization | Plan optimization | Yes | | Plan optimization | Multi criteria optimization | No | | Plan evaluation | Plan evaluation | Yes | | Plan evaluation | Robust evaluation | No | | Plan evaluation | Biological evaluation | No | | QA preparation | QA preparation | Yes | | Treatment adaptation | Dose tracking | No | | Treatment adaptation | Adaptive replanning | No | In each planning activity the user can perform some operations that are considered to form a basic task or planning activity in oncology. Together, the planning activities cover a complete treatment planning use case. Each planning activity consists of one or more modules; each corresponding to a coherent group of functionalities. A module may include one or several workspaces, where each workspace holds an optimized layout of regions populated with GUI components that are needed to get through the use case of the module. The device to be marketed, RayStation 12A, contains modified features compared to version RayStation 11B as indicated below: - Support for eye planning with wedges - A wedge can be used to improve the conformity of dose distribution and spare risk O organs. The wedge is not patient specific, meaning that the user must choose a wedge from a predefined set of wedges for the treatment machine. Each wedge in the machine model is associated with an identifying name, a physical opening angle, and a material. - Automatic field in field planning ● {5}------------------------------------------------ - A uniform dose can be achieved on a selected target using automatically generated 3Do CRT fields/segments. Starting from a number of beams (usually 2 or 3) and an initial segment for each beam the action sequentially adds a given number of segments to each beam, choosing apertures and segment weights so that the final dose is approximately uniform on the target. The apertures of the inner segments always have openings that are subsets of the openings of the respective initial segments. - Brachy therapy support for Elekta Flexitron® afterloaders - The connectivity to the Elekta Flexitron® afterloader is validated for the brachy planning O in RayStation using the TG43 formalism. - Electron Monte Carlo dose engine update . - O The previously used plug-in for in-patient transport for the electron Monte Carlo dose engine (VMC++) was replaced by a fully integrated electron Monte Carlo dose engine. In the development of the new dose engine, improvements have been made to increase the accuracy for small cutout sizes. #### 1.9 Indications for Use RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. #### 1.10 Technological characteristics summary The following comparison table summarized the technological characteristics. In the table below, RayStation 12A is compared to the predicate device RayStation 11B. | Item | Compared to<br>RayStation 11B | Comment | |-----------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Hardware platform | Substantially Equivalent | Both systems use standard office PCs as hardware platform. | | Operating system | Substantially Equivalent | Both systems use Windows 10 Professional (or higher) and<br>Windows Server 2012 R2 (or higher). | | Target population | Substantially Equivalent | RayStation 11B and RayStation 12A are intended for the<br>same target population and anatomical sites; persons that | | Anatomical sites | Substantially Equivalent | have been prescribed an external beam radiation therapy or<br>medical oncology treatment. | | Human factors | Substantially Equivalent | In terms of human factors, the systems are considered<br>equivalent. The user interfaces are almost identical. | | Standards met | Substantially Equivalent | Both systems comply with the following FDA-recognized<br>consensus standards: IEC 61217:2011, IEC 62083, IEC<br>62304:2015, IEC 62366-1:2015, ISO 14971:2019 and with<br>IEC 60601-2-68:2014 standard. | | Image types | Substantially Equivalent | RayStation 11B and RayStation 12A both support CT, PET<br>and MR images for identifying patient organs and contouring. | | Reporting aspects | Substantially Equivalent | When evaluating and approving treatment plans, all necessary<br>data is presented to the user and available in print in both<br>systems. | | Image storing | Substantially Equivalent | None of the systems is intended for long term storage of<br>images or other patient data. | | Network / remote<br>connections and<br>capabilities | Substantially Equivalent | Both systems are capable of network transfer of patient data<br>using the DICOM protocol. RayStation 12A and RayStation<br>11B are designed for desktop use and for remote access using<br>standard virtualization techniques. Remote connection to the<br>system is verified in detail and equivalent to local connection. | {6}------------------------------------------------ | Cybersecurity | Substantially Equivalent | Both systems are compliant with the requirements listed in<br>the FDA guideline 1825 "Content of Premarket Submissions<br>for Management of Cybersecurity in Medical Devices". | |---------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Description | Present in<br>RayStation<br>11B<br>(K220141) | Present in<br>RayStation<br>12A | Significantly<br>changed? | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------|------------------------------------------------------------------------------------| | 3D<br>visualization | Displays the patient geometry and<br>structures in three dimensions, with the<br>possibility to rotate the patient image. If<br>available, the dose distribution and beam<br>modifiers are shown as well. | Yes | Yes | No | | Adaptive<br>replanning | The process of replanning the treatment<br>for a patient, based on information about<br>e.g. patient geometry, biology and dose<br>delivery acquired during treatment. | Yes | Yes | No | | Beam<br>commissioning | Modeling of the radiation beam using a<br>limited set of measurements on the clinical<br>beam for commissioning treatment<br>machines to make them available for<br>treatment planning. | Yes | Yes | No | | Beam design | Definition of beam orientations, apertures<br>and various beam modifiers in order to<br>manually create a treatment plan. | Yes | Yes | No | | Beam set-up | Manual or automatic definition of<br>isocenter, selection of treatment unit from<br>the set of commissioned treatment<br>machines, and specification of<br>gantry/couch/collimator angles. | Yes | Yes | Yes, new<br>functionality<br>Automatic<br>Field in Field<br>planning was<br>added. | | Beam's eye<br>view | Displays the beam's eye view of the<br>patient structures, fluence and beam<br>modifier settings for any beam. | Yes | Yes | No | | Brachy<br>planning | Tools for planning of HDR brachytherapy<br>treatments. Includes channel<br>reconstruction and optimization and<br>editing of dwell times. | Yes | Yes | Yes. Now<br>supports<br>Elekta<br>Flexitron<br>afterloaders. | | CyberKnife<br>planning | CyberKnife planning is completely<br>integrated in RayStation. This includes<br>optimization of high quality treatment<br>plans collimated with MLC, fixed cones<br>or iris cones, as well as support for all<br>CyberKnife Synchrony techniques for<br>target tracking and real time motion<br>synchronization. | Yes | Yes | No | | Deformable<br>registration | Establishing a point-to-point mapping<br>between two images using a deformation<br>model. Used for mapping of dose and<br>structures between images. | Yes | Yes | No | | DICOM RT<br>export | Export of images, structure set, plan, and<br>dose according to the DICOM RT<br>standard. | Yes | Yes | No | | DICOM RT<br>import | Import of images, structure set, plan, and<br>dose according to the DICOM RT<br>standard. | Yes | Yes | No | | Dose<br>calculation<br>electrons | For electron beams RayStation calculates<br>dose by the Monte Carlo technique. The<br>electron beam phase space is generated in<br>run time by sampling from a phase space<br>model where the electrons are created at<br>the secondary scattering foil. Both the<br>electron transport through the treatment<br>head and the in-patient dose computation<br>is performed using the Monte Carlo<br>algorithm.<br><br>In versions prior to RayStation 11A, the<br>transport through the treatment head has<br>been handled by a Monte Carlo algorithm<br>developed by RaySearch, while the in-<br>patient transport and dose computation has<br>been the responsibility of the plug-in dose<br>engine VMC++. In RayStation 12A, the<br>VMC++ dose engine has been exchanged<br>with an in-patient Monte Carlo transport<br>and dose scoring algorithm fully<br>developed by RaySearch. Additionally,<br>some minor improvements have been<br>made to the treatment head transport, but<br>this part is essentially the same as in<br>RayStation 11B.<br><br>There are substantial similarities between<br>the replaced VMC++ code and the<br>EGSnrc code and these two Monte Carlo<br>dose engines agrees on sub-percent level<br>[1][2]. The dose engine developed by<br>RaySearch is similar to the EGSnrc, as has<br>been described in references 11, 12, 17, 24<br>and 108 in the 008 RSL-D-RS-12A-REF-<br>EN-1.0-2022-06-23 RayStation 12A<br>Reference Manual. Therefore, we<br>conclude that the electron dose engine<br>used in RayStation 12A (fully developed<br>by RaySearch) is substantially equivalent<br>to the electron dose engine used in<br>RayStation 11B (in-patient dose<br>computation handled by VMC++). | Yes | Yes | Yes | | | | | | | | | The supporting testing confirms<br>equivalence between the RayStation 11B<br>and RayStation 12A dose engines.<br>Regression tests performed during the<br>electron dose engine validation between<br>the two versions are within tolerance<br>limits which shows a similar level of<br>accuracy between the two dose engines.<br>Acceptance criteria for comparison with<br>previous RayStation dose: The calculated<br>doses shall fail for less than 2% of the data<br>points for gamma 2%/2mm.<br>References:<br> | | | | | | Society (Cat. No.00CH37143), Chicago,<br>IL, USA, 2000, pp. 1490-1493 vol.2, doi:<br>10.1109/IEMBS.2000.898024.<br>[2] Kawrakow I, Fippel M, Friedrich K.<br>3D electron dose calculation using a<br>Voxel based Monte Carlo algorithm<br>(VMC). Med Phys. 1996 Apr;23(4):445-<br>57. doi: 10.1118/1.597673. PMID:<br>9157256. | | | | | Dose<br>calculation<br>photons | For <b>photon</b> beams RayStation calculates<br>dose by the point kernel superposition<br>method (a.k.a. Collapsed Cone) or a<br>Monte Carlo algorithm for radiation<br>transport. The incident energy fluence is<br>modeled as a superposition of a primary<br>energy fluence and a scatter energy<br>fluence. The dose contribution from<br>contamination electrons is calculated by a<br>pencil beam algorithm. | Yes | Yes | No | | Dose<br>calculation<br>proton | For <b>proton</b> beams RayStation uses either<br>the pencil beam algorithm with the Fermi-<br>Eyges formalism, or a Monte Carlo<br>algorithm for radiation transport. For<br>passive beams the beam model accounts<br>for the collimator and compensator block.<br>For scanning beams the beam model<br>accounts for the spot phase space<br>including effects of air-scatter and beam<br>paths through magnetic deflection<br>elements. The user defined block aperture<br>is taken into account in spot selection and<br>optimization. In addition to this the<br>relative biological effect (RBE) of proton<br>beams is taken into account, resulting in a<br>photon equivalent dose. | Yes | Yes | No | | Dose<br>calculation<br>brachy | For brachy plans RayStation calculates<br>dose based on the TG43 formalism. | Yes | Yes | No | | Dose display<br>(2D) | Displays the patient geometry with<br>structures superimposed on the image data<br>together with the dose distribution in<br>transversal, sagittal, and coronal<br>directions. | Yes | Yes | No | | Dose tracking | Dose tracking scenarios including<br>deformable registration of one CT or<br>CBCT to another and subsequent<br>deformation and accumulation of dose. | Yes | Yes | No | | Eye planning | Tools for specifying a highly detailed<br>geometrical model of the eye based on<br>measurements from ultrasound and<br>surgery. Support for positioning of<br>tantalum clips. Import and visualization of<br>fundus images. Creation and dose<br>computation of proton plans with gaze<br>angle-based treatment directions. | Yes | Yes | Yes, Now<br>supports eye<br>planning with<br>wedges. | | Fallback<br>planning | Automatic generation of fallback plans<br>using alternative treatment machines and<br>treatment techniques. User-defined<br>protocols specifies the setup of the<br>fallback plans which are automatically<br>generated from the protocols and<br>optimized using dose mimicking<br>functions. | Yes | Yes | No | | Image<br>conversion | Conversion of CBCT images to synthetic<br>CT images that can be used for more<br>accurate dose calculations. | Yes | Yes | No | | Inverse<br>planning | The user can define optimization settings<br>such as optimization tolerance and<br>maximum number of iterations as well as<br>segmentation settings on the multileaf<br>collimator and the Pencil Beam Scanning<br>spot pattern. An interface for controlling<br>the optimization process is provided and<br>the progress of optimization is displayed<br>in a view. The system generates control<br>points for step-and shoot MLC plans,<br>Sliding Window plans (DMLC), rotational<br>plans (VMAT), 3DCRT plans, Wave Arc<br>plans, TomoTherapy plans and proton<br>Pencil Beam Scanning plans, using the<br>defined optimization problem. The inverse<br>planning can be carried out either through<br>a conventional inverse approach or by<br>using multi-criteria optimization (photons<br>and protons only). | Yes | Yes | No | | LET evaluation | Computation and evaluation of dose-averaged LET (Linear Energy Transfer) for proton plans. LET is an additional physical quantity that can be used to assess the radiobiological effect of the proton radiation. | Yes | Yes | No | | Machine database | Microsoft SQL database for storage of beam model parameters, machine constraints and dose curves with dosimetric data for treatment units. | Yes | Yes | No | | MR based planning | Allowing MR-images as planning images and base dose computation on material override ROIs. | Yes | Yes | No | | Optimization functions | The optimization functions are specified in terms of objectives and constraints to form the optimization problem that is solved by the optimization engine. | Yes | Yes | No | | Patient anatomy modeling | Manual and semi-automatic segmentation tools for contouring ROIs slice by slice together with semi-automated generation of the patient outline ROI.<br><br>The model-based segmentation technique allows for semi-automatic delineation of structures by matching 3D shape models of the structures to new image data.<br><br>With atlas-based segmentation, the user can define templates consisting of already segmented image data and use this template for segmentation of new patient images.<br><br>With deep learning segmentation, the user can use trained deep learning models for automatic segmentation of new patient images. (The model training is performed offline on clinical CT and structure data.) | Yes | Yes | No | | Patient database | Microsoft SQL database for storage of all patient and plan data. Not for long term storage. | Yes | Yes | No | | Plan Explorer | The system computes a large set of plans according to given rules and the user is provided with tools to select good plans from these.…