ClearCalc Model RADCA V2

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Radformation, Inc. % Kurt Sysock Co-founder/CEO 335 Madison Avenue, 4th floor NEW YORK NY 10017 Re: K220582 Trade/Device Name: ClearCalc Model RADCA V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: July 18, 2022 Received: July 21, 2022 Dear Kurt Sysock: 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). 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Sincerely, for Julie Sullivan, Ph.D. Assistant Director 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) #### K220582 Device Name ClearCalc Model RADCA V2 Indications for Use (Describe) ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm. Type of Use (Select one or both, as applicable)X 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}------------------------------------------------ This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92. | Table 1 : Submitter's Information | | |-----------------------------------|------------------------------------------------------| | Submitter's Name: | Kurt Sysock | | Company: | Radformation, Inc. | | Address: | 335 Madison Avenue, 16th Floor<br>New York, NY 10017 | | Contact Person: | Alan Nelson<br>Chief Science Officer, Radformation | | Phone: | 518-888-5727 | | Fax: | -------- | | Email: | anelson@radformation.com | | Date of Summary Preparation | 8/21/2022 | # 5.1. Submitter's Information # 5.2. Device Information | Table 2 : Device Information | | |------------------------------|-----------------------------------------------------------------------------------| | Trade Name: | ClearCalc Model RADCA V2 | | Common Name: | Secondary Check Quality Assurance Software, Patient<br>Quality Assurance Software | | Classification Name: | Class II | | Classification: | Medical charged-particle radiation therapy system | | Regulation Number: | 892.5050 | | Product Code: | MUJ | | Classification Panel: | Radiology | {4}------------------------------------------------ # 5.3. Predicate Device and Reference Device Information ### Primary Predicate Device ClearCalc Model RADCA V2 (Subject Device) makes use of its prior submission - ClearCalc Model RADCA (K193640) - as the primary Predicate Device. ### Reference Devices With the additions included in the submission, ClearCalc Model RADCA V2 also makes use of RadCalc Version 7.1 (K193381) and myQA iON (K201798) as Reference Devices for the new functionality. # 5.4. Device Description The ClearCalc Model RADCA V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming interfaces to perform a dose and/or monitor unit (MU) calculation on the incoming treatment planning parameters. It is designed to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm. # 5.5. Indications for Use ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm. # 5.6. Technological Characteristics ### Predicate Device ClearCalc Model RADCA V2 (Subject Device) makes use of its prior submission - ClearCalc Model RADCA (K193640) - as the Predicate Device. The functionality and technical components of this prior submission remain unchanged in ClearCalc Model RADCA V2. This submission is intended to build on the functionality and technological components of the 510(k) cleared ClearCalc Model RADCA. Similar to the Predicate Device software, ClearCalc Model RADCA V2 is designed to run on Windows Operating Systems, performs dose and/or monitor unit (MU) calculations on the incoming supported treatment data, and displays the calculated results to the user. Supported Treatment Planning System and Application Programming Interfaces are used by trained, clinically-qualified radiation oncology personnel to simulate radiation therapy treatments for malignant or benign diseases. The intended user base has not changed from the Predicate Device. ClearCalc may call either its local calculation engine (the same finite-size pencil beam algorithm as with the Predicate Device) or now optionally call a monte carlo dose calculation engine to perform dose and/or MU calculations. Though the monte carlo dose calculation {5}------------------------------------------------ engine is new functionality, it serves the same purpose as the currently-implemented Finite-Size Pencil Beam (FSPB) algorithm and is launched from the local User Interface (UI). Additionally, this new algorithm is a monte carlo-based calculation, which is the "gold standard" for radiotherapy treatment planning and can improve the accuracy of the results provided by ClearCalc. Additionally, new input files are being supported with the Subject Device, namely machine treatment log files and virtual source models. Machine log files record the precise machine parameter setting of linear accelerator deliveries during a set treatment delivery. These files record parameters similar to the treatment plan except they are recorded from a pre-treatment delivery at the machine instead of from a Treatment Planning System. Instead of using the treatment planning parameters, ClearCalc will use the delivered treatment parameters from the machine to re-calculate the dose from the given plan. Since the parameters in machine treatment log files are nearly identical to those captured in a treatment plan, this functionality does not raise any new questions in terms of safety and effectiveness compared to the predicate. The virtual source models are used by the monte carlo dose calculation engine to complete calculations and do not affect the current technological functionality when compared to the Predicate Device. Virtual source models are a different way to store pertinent beam data for dose calculation and originate from the beam data already stored in the Predicate Device. As such, they do not raise any new concerns regarding the safety or effectiveness of the Subject Device compared to the predicate. Due to the technological characteristic similarities, the Subject Device raises no new concerns regarding safety and effectiveness compared to the predicate. | Table 3: Substantial Equivalence ClearCalc Model RADCA V2 vs. Predicate Device and<br>Reference Devices | | | | | |---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameters | Subject Device:<br>ClearCalc Model<br>RADCA V2 | Predicate Device:<br>ClearCalc Model<br>RADCA | Reference Device:<br>RadCalc Version<br>7.1 (K193381) | Reference<br>Device:<br>myQA iON<br>(K201798) | | Summarized<br>Indications<br>for use | Intended to assist<br>radiation treatment<br>planners in<br>determining if their<br>treatment planning<br>calculations are<br>accurate using an<br>independent Monitor<br>Unit (MU) and dose<br>calculation algorithm.<br>(Equivalent) | Intended to assist<br>radiation treatment<br>planners in<br>determining if their<br>treatment planning<br>calculations are<br>accurate using an<br>independent<br>Monitor Unit (MU)<br>and dose<br>calculation<br>algorithm. | A means of<br>validating the<br>monitors units or<br>radiation dose to<br>points that have<br>been calculated by<br>the primary radiation<br>therapy planning<br>system for external<br>beam radiation<br>therapy and/or<br>brachytherapy<br>treatments. In<br>addition to this, | To perform patient<br>quality assurance<br>activities for<br>radiation therapy<br>treatment delivery<br>systems. myQA<br>iON is a software<br>toolbox allowing<br>the<br>Medical Physicist<br>to perform quality<br>assurance<br>activities before<br>and after the | | | | | RadCalc Software<br>can also be used as<br>the primary means of<br>calculating monitor<br>units for external<br>beam radiation<br>treatments in<br>situations where the<br>physician does not<br>order the use of a<br>radiation therapy<br>plan. Users may also<br>send/receive results<br>from an eternal dose<br>calculation engine,<br>whereby the results<br>are displayed in<br>RadCalc for<br>evaluation. | patient treatment<br>fractions for all<br>patients<br>undergoing<br>radiation therapy. | | Energy<br>Used and/or<br>Delivered | None - software-only<br>application. The<br>software application<br>does not deliver or<br>depend on energy<br>delivered to or from<br>patients.<br>(Substantially<br>equivalent) | None -<br>software-only<br>application. The<br>software<br>application does<br>not deliver or<br>depend on energy<br>delivered to or<br>from patients. | None - software only<br>application. The<br>software application<br>does not deliver or<br>depend on energy<br>delivered to or from<br>patients | None - software<br>only application.<br>The software<br>application does<br>not deliver or<br>depend on energy<br>delivered to or<br>from patients | | Intended<br>users | Trained radiation<br>oncology personnel<br>(Substantially<br>equivalent) | Trained radiation<br>oncology<br>personnel | Trained radiation<br>oncology personnel | Trained radiation<br>oncology health<br>professionals | | OTC/Rx | Rx (Substantially<br>equivalent) | Rx | Rx | Rx | | Design:<br>Graphical<br>User<br>Interface | Contains a Data<br>Visualization /<br>Graphical User<br>Interface<br>(Substantially<br>Equivalent) | Contains a Data<br>Visualization /<br>Graphical User<br>Interface | Contains a Data<br>Visualization /<br>Graphical User<br>Interface | Contains a Data<br>Visualization /<br>Graphical User<br>Interface | | Design:<br>Supported<br>files | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data as well as | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including<br>treatment field<br>parameters) data | Files containing<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data | Files containing<br>Structure Set, and<br>Treatment Plan<br>(including<br>treatment field<br>parameters) data<br>as well as machine<br>treatment log files | | | machine treatment<br>log files<br>(Substantially<br>equivalent) | | | | | Design:<br>Reporting<br>and data<br>routing | Reporting built-in<br>and user has ability<br>to customize<br>(Substantially<br>equivalent) | Reporting built-in<br>and user has<br>ability to customize | Reporting built-in<br>and user has ability<br>to customize | Reporting built-in<br>and user has<br>ability to customize | | Input | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data (Substantially<br>equivalent) | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including<br>treatment field<br>parameters) data | Files containing<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data | N/A | | Functionality | Utilizes a Finite-Size<br>Pencil Beam (FSPB)<br>algorithm to calculate<br>MU/Dose on a<br>per-field<br>basis.ClearCalc<br>utilizes the full 3D<br>geometry of the<br>patient for<br>heterogeneity<br>corrections and<br>simulating the scatter<br>conditions of the<br>actual patient. Users<br>may also<br>send/receive data<br>from its monte carlo<br>dose calculation<br>engine (branded as<br>RadMonteCarlo),<br>whereby the results<br>are displayed in<br>ClearCalc for<br>evaluation.<br>(Substantially<br>equivalent) | Utilizes a<br>Finite-Size Pencil<br>Beam (FSPB)<br>algorithm to<br>calculate MU/Dose<br>on a per-field<br>basis.ClearCalc<br>utilizes the full 3D<br>geometry of the<br>patient for<br>heterogeneity<br>corrections and<br>simulating the<br>scatter conditions<br>of the actual<br>patient. | Utilizes a Clarkson<br>summation algorithm<br>to calculate<br>MU/Dose on a<br>per-field basis.<br>RadCalc utilizes a<br>consistent flat<br>phantom geometry<br>using radiological<br>equivalent depth for<br>heterogeneity<br>corrections and<br>includes modules<br>that allow the user to<br>indicate changes in<br>scatter conditions<br>(e.g. for breast<br>treatments). Users<br>may also<br>send/receive results<br>from an eternal dose<br>calculation engine,<br>whereby the results<br>are displayed in<br>RadCalc for<br>evaluation. | N/A | | Output | ClearCalc calculates<br>the dose from fields | ClearCalc<br>calculates the | RadCalc calculates<br>the dose from fields | N/A | | | in a plan and<br>displays results for<br>per-field MU and<br>provides a difference<br>metric for evaluation<br>in tabular format.<br>Users can also<br>evaluate global point<br>doses, as well as<br>per-field doses and,<br>when applicable, a<br>generated dose<br>volume histogram..<br>(Substantially<br>equivalent) | dose from fields in<br>a plan and<br>displays results for<br>per-field MU and<br>provides a<br>difference metric<br>for evaluation in<br>tabular format.<br>Users can also<br>evaluate global<br>point doses, as<br>well as per-field<br>doses. | in a plan and<br>displays results for<br>per-field MU and<br>provides a difference<br>metric for evaluation<br>in tabular format.<br>Users can also<br>evaluate global point<br>doses, as well as<br>per-field doses. | | | | ClearCalc vs. Predicate Devices Electron MU and Dose Calculation | | | | | Input | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data (Substantially<br>equivalent) | Files/Treatment<br>Planning System<br>API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including<br>treatment field<br>parameters) data | Files containing<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data | N/A | | Functionality | Utilize a library of<br>custom cutouts and<br>computes cutout<br>factors using a<br>sector integration<br>method. Cutout<br>factors may also be<br>user-entered. Users<br>may also<br>send/receive results<br>from its monte carlo<br>dose calculation<br>engine (branded as<br>RadMonteCarlo),<br>whereby the results<br>are displayed in<br>ClearCalc for<br>evaluation.<br>(Substantially<br>equivalent) | Utilize a library of<br>custom cutouts<br>and computes<br>cutout factors<br>using a sector<br>integration<br>method. Cutout<br>factors may also<br>be user-entered. | Utilize a library of<br>custom cutouts and<br>computes cutout<br>factors using a<br>sector integration or<br>square root method.<br>Cutout factors may<br>also be user-entered.<br>Users may also<br>send/receive results<br>from an eternal dose<br>calculation engine,<br>whereby the results<br>are displayed in<br>RadCalc for<br>evaluation. | N/A | | Output | ClearCalc calculates<br>dose based on<br>electron field | ClearCalc<br>calculates dose<br>based on electron | RadCalc calculates<br>dose based on<br>electron field | N/A | | | parameters and<br>cutout geometry, and<br>displays results for<br>per-field MU and/or<br>dose and provides a<br>difference metric for<br>evaluation in tabular<br>format and, when<br>applicable, a<br>generated dose<br>volume histogram.<br>(Substantially<br>equivalent) | field parameters<br>and cutout<br>geometry, and<br>displays results for<br>per-field MU<br>and/or dose and<br>provides a<br>difference metric<br>for evaluation in<br>tabular format. | parameters and<br>cutout geometry, and<br>displays results for<br>per-field MU and/or<br>dose and provides a<br>difference metric for<br>evaluation in tabular<br>format. | | | | ClearCalc vs. RadCalc Brachytherapy Dose Calculation | | | | | Input | Files or Treatment<br>Planning System<br>API-provided data<br>containing Treatment<br>Plan (including<br>source positions and<br>dwell times) data<br>(Substantially<br>equivalent) | Files or Treatment<br>Planning System<br>API-provided data<br>containing<br>Treatment Plan<br>(including source<br>positions and dwell<br>times) data | Files containing<br>Treatment Plan<br>(including source<br>positions and dwell<br>times) data | N/A | | Functionality | Utilizes the AAPM<br>TG-43 protocol for its<br>brachytherapy dose<br>calculations<br>(Substantially<br>equivalent) | Utilizes the AAPM<br>TG-43 protocol for<br>its brachytherapy<br>dose calculations | Utilizes the AAPM<br>TG-43 protocol for its<br>brachytherapy dose<br>calculations | N/A | | Output | ClearCalc calculates<br>dose to arbitrary<br>calculation point<br>locations and<br>presents difference<br>metrics comparing<br>the TPS dose vs.<br>ClearCalc dose in a<br>tabular format.<br>(Substantially<br>equivalent) | ClearCalc<br>calculates dose to<br>arbitrary<br>calculation point<br>locations and<br>presents difference<br>metrics comparing<br>the TPS dose vs.<br>ClearCalc dose in<br>a tabular format. | RadCalc calculates<br>dose to arbitrary<br>calculation point<br>locations and<br>presents difference<br>metrics comparing<br>the TPS dose vs.<br>RadCalc dose in a<br>tabular format. | N/A | | Parameters | Subject Device:<br>ClearCalc Model<br>RADCA V2 | Predicate Device:<br>ClearCalc Model<br>RADCA | Predicate Device:<br>RadCalc Version<br>7.1 (K193381) | Predicate Device:<br>myQA iON<br>(K201798) | | ClearCalc vs. myQA iON Proton MU and Dose Calculation | | | | | | Input | Files/Treatment<br>Planning System | N/A | N/A | Files containing<br>Structure Set, and | | | API-provided data<br>containing CT,<br>Structure Set, and<br>Treatment Plan<br>(including treatment<br>field parameters)<br>data (Minor<br>differences) | | | Treatment Plan<br>(including<br>treatment field<br>parameters) data | | Functionality | Sends/receives data<br>from its monte carlo<br>dose calculation<br>engine (branded as<br>RadMonteCarlo) to<br>calculate proton<br>plans from the<br>necessary files and<br>displays the results<br>to the user.<br>(Substantially<br>equivalent) | N/A | N/A | Sends/receives<br>data from an<br>external dose<br>calculation engine<br>to calculate proton<br>plans from the<br>necessary files<br>and displays the<br>results to the user. | | Output | ClearCalc displays<br>the dose results<br>received from the<br>RadMonteCarlo dose<br>calculation engine<br>and allows the user<br>to analyze the results<br>in the UI.<br>(Substantially<br>equivalent) | N/A | N/A | myQA iON<br>displays the dose<br>results received<br>from the external<br>dose calculation<br>engine and allows<br>the user to analyze<br>the results in the<br>UI. | | ClearCalc vs. myQA iON Machine Treatment Log File Analysis | | | | | | Input | Files or Treatment<br>Planning System<br>API-provided data<br>containing Treatment<br>Plan data as well as<br>machine log files<br>from a pre-treatment<br>or treatment session<br>(Substantially<br>equivalent) | N/A | N/A | Files containing<br>Treatment Plan<br>data as well as<br>machine log files<br>from a<br>pre-treatment or<br>treatment session | | Functionality | Utilizes the machine<br>logs files to<br>reconstruct the<br>delivered dose<br>utilizing a dose<br>calculation from the<br>set machine<br>parameters. | N/A | N/A | Utilizes the<br>machine logs files<br>to reconstruct the<br>delivered dose<br>utilizing a dose<br>calculation from the<br>set machine<br>parameters. | | | (Substantially<br>equivalent) | | | | | Output | ClearCalc displays<br>the log file<br>calculation result to<br>the user via<br>displayed dose<br>information and<br>provides a difference<br>metric for evaluation.<br>(Substantially<br>equivalent) | N/A | N/A | myQA iON<br>displays the log file<br>calculation result<br>to the user via<br>displayed dose<br>information and<br>provides a<br>difference metric<br>for evaluation. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ # 5.7. Performance Data As with the Predicate Device and Reference Devices, no clinical trials were performed for ClearCalc. Verification tests were performed to ensure that the software works as intended and passffail criteria were used to verify requirements. Validation testing was performed to ensure that the software was behaving as intended, and results from ClearCalc were validated against accepted results for known planning parameters from clinically-utilized treatment planning systems. All passing criteria for ClearCalc's primary dose calculation algorithms (FSPB for photon plans, TG-71 for electron plans, and TG-43 for brachytherapy plans) remain consistent with the Predicate Device. Passing criteria for monte carlo calculations was a gamma analysis passing rate of >93% with +/-3% relative dose agreement and 3mm distance to agreement (DTA). The verification and validation testing passed in all test cases. ### 5.8. Conclusion ClearCalc Model RADCA V2 is deemed substantially equivalent to the scope of Predicate Device, ClearCalc Model RADCA (K193640). Additional functionality for monte carlo calculations was supported with Reference Device RadCalc Version 7.1 (K1933981) and proton and machine treatment log file analysis for photons functionality was demonstrated with Reference Device myQA iON (K201798). Verification and Validation testing and the Risk Management Report demonstrate that ClearCalc is as safe and effective as the Predicate Device and Reference Devices. The minor technological differences between ClearCalc and the Predicate Device and Reference Devices do not raise any questions on the safety and effectiveness of the Subject Device.