(174 days)
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.
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.
The provided text describes ClearCalc Model RADCA V2 and its substantial equivalence to predicate devices. However, the document does NOT contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with detailed statistical results. Instead, it states that "Verification tests were performed to ensure that the software works as intended and pass/fail 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."
Therefore, I can provide the acceptance criteria as stated for the ClearCalc Model RADCA V2's primary dose calculation algorithms and the monte carlo calculations, but comprehensive study details such as sample size, data provenance, expert ground truth, adjudication methods, or separate training/test sets are not available in the provided text.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Calculation Algorithm | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| FSPB (Photon Plans) | Passing criteria consistent with Predicate Device ClearCalc Model RADCA | Passed in all test cases |
| TG-71 (Electron Plans) | Passing criteria consistent with Predicate Device ClearCalc Model RADCA | Passed in all test cases |
| TG-43 (Brachytherapy Plans) | Passing criteria consistent with Predicate Device ClearCalc Model RADCA | Passed in all test cases |
| Monte Carlo Calculations | Gamma analysis passing rate of >93% with +/-3% relative dose agreement and 3mm Distance To Agreement (DTA) | Passed in all test cases |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "all test cases" without quantifying the number of cases.
- Data Provenance: Not explicitly stated. The text refers to "known planning parameters from clinically-utilized treatment planning systems," suggesting the data would be representative of clinical use but does not specify country of origin or if it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth was established from "accepted results for known planning parameters from clinically-utilized treatment planning systems." This implies that the ground truth is derived from established clinical practices and systems, which are typically validated by qualified medical physicists and radiation oncologists, but specific expert involvement in this validation is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The validation relies on comparison to "accepted results."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The device is a "Secondary Check Quality Assurance Software" designed to assist radiation treatment planners by providing independent calculation. It does not involve human readers making diagnoses or interpretations that would be augmented by AI in a MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described verification and validation tests assess the algorithm's performance against "accepted results" from clinical systems, which is a standalone evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: "Accepted results for known planning parameters from clinically-utilized treatment planning systems." This implies a form of established, clinically validated ground truth based on the outputs of other (predicate/reference) treatment planning systems the device is checking.
8. The sample size for the training set:
- Training Set Sample Size: Not specified. The text focuses on verification and validation testing, not on the training of the underlying algorithms.
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified. As the document focuses on validation rather than algorithm training, this information is not provided.
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Image /page/0/Picture/0 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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
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). 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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,
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
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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)
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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 FloorNew York, NY 10017 |
| Contact Person: | Alan NelsonChief 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, PatientQuality Assurance Software |
| Classification Name: | Class II |
| Classification: | Medical charged-particle radiation therapy system |
| Regulation Number: | 892.5050 |
| Product Code: | MUJ |
| Classification Panel: | Radiology |
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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
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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 andReference Devices | ||||
|---|---|---|---|---|
| Parameters | Subject Device:ClearCalc ModelRADCA V2 | Predicate Device:ClearCalc ModelRADCA | Reference Device:RadCalc Version7.1 (K193381) | ReferenceDevice:myQA iON(K201798) |
| SummarizedIndicationsfor use | Intended to assistradiation treatmentplanners indetermining if theirtreatment planningcalculations areaccurate using anindependent MonitorUnit (MU) and dosecalculation algorithm.(Equivalent) | Intended to assistradiation treatmentplanners indetermining if theirtreatment planningcalculations areaccurate using anindependentMonitor Unit (MU)and dosecalculationalgorithm. | A means ofvalidating themonitors units orradiation dose topoints that havebeen calculated bythe primary radiationtherapy planningsystem for externalbeam radiationtherapy and/orbrachytherapytreatments. Inaddition to this, | To perform patientquality assuranceactivities forradiation therapytreatment deliverysystems. myQAiON is a softwaretoolbox allowingtheMedical Physicistto perform qualityassuranceactivities beforeand after the |
| RadCalc Softwarecan also be used asthe primary means ofcalculating monitorunits for externalbeam radiationtreatments insituations where thephysician does notorder the use of aradiation therapyplan. Users may alsosend/receive resultsfrom an eternal dosecalculation engine,whereby the resultsare displayed inRadCalc forevaluation. | patient treatmentfractions for allpatientsundergoingradiation therapy. | |||
| EnergyUsed and/orDelivered | None - software-onlyapplication. Thesoftware applicationdoes not deliver ordepend on energydelivered to or frompatients.(Substantiallyequivalent) | None -software-onlyapplication. Thesoftwareapplication doesnot deliver ordepend on energydelivered to orfrom patients. | None - software onlyapplication. Thesoftware applicationdoes not deliver ordepend on energydelivered to or frompatients | None - softwareonly application.The softwareapplication doesnot deliver ordepend on energydelivered to orfrom patients |
| Intendedusers | Trained radiationoncology personnel(Substantiallyequivalent) | Trained radiationoncologypersonnel | Trained radiationoncology personnel | Trained radiationoncology healthprofessionals |
| OTC/Rx | Rx (Substantiallyequivalent) | Rx | Rx | Rx |
| Design:GraphicalUserInterface | Contains a DataVisualization /Graphical UserInterface(SubstantiallyEquivalent) | Contains a DataVisualization /Graphical UserInterface | Contains a DataVisualization /Graphical UserInterface | Contains a DataVisualization /Graphical UserInterface |
| Design:Supportedfiles | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters)data as well as | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(includingtreatment fieldparameters) data | Files containingStructure Set, andTreatment Plan(including treatmentfield parameters)data | Files containingStructure Set, andTreatment Plan(includingtreatment fieldparameters) dataas well as machinetreatment log files |
| machine treatmentlog files(Substantiallyequivalent) | ||||
| Design:Reportingand datarouting | Reporting built-inand user has abilityto customize(Substantiallyequivalent) | Reporting built-inand user hasability to customize | Reporting built-inand user has abilityto customize | Reporting built-inand user hasability to customize |
| Input | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters)data (Substantiallyequivalent) | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(includingtreatment fieldparameters) data | Files containingStructure Set, andTreatment Plan(including treatmentfield parameters)data | N/A |
| Functionality | Utilizes a Finite-SizePencil Beam (FSPB)algorithm to calculateMU/Dose on aper-fieldbasis.ClearCalcutilizes the full 3Dgeometry of thepatient forheterogeneitycorrections andsimulating the scatterconditions of theactual patient. Usersmay alsosend/receive datafrom its monte carlodose calculationengine (branded asRadMonteCarlo),whereby the resultsare displayed inClearCalc forevaluation.(Substantiallyequivalent) | Utilizes aFinite-Size PencilBeam (FSPB)algorithm tocalculate MU/Doseon a per-fieldbasis.ClearCalcutilizes the full 3Dgeometry of thepatient forheterogeneitycorrections andsimulating thescatter conditionsof the actualpatient. | Utilizes a Clarksonsummation algorithmto calculateMU/Dose on aper-field basis.RadCalc utilizes aconsistent flatphantom geometryusing radiologicalequivalent depth forheterogeneitycorrections andincludes modulesthat allow the user toindicate changes inscatter conditions(e.g. for breasttreatments). Usersmay alsosend/receive resultsfrom an eternal dosecalculation engine,whereby the resultsare displayed inRadCalc forevaluation. | N/A |
| Output | ClearCalc calculatesthe dose from fields | ClearCalccalculates the | RadCalc calculatesthe dose from fields | N/A |
| in a plan anddisplays results forper-field MU andprovides a differencemetric for evaluationin tabular format.Users can alsoevaluate global pointdoses, as well asper-field doses and,when applicable, agenerated dosevolume histogram..(Substantiallyequivalent) | dose from fields ina plan anddisplays results forper-field MU andprovides adifference metricfor evaluation intabular format.Users can alsoevaluate globalpoint doses, aswell as per-fielddoses. | in a plan anddisplays results forper-field MU andprovides a differencemetric for evaluationin tabular format.Users can alsoevaluate global pointdoses, as well asper-field doses. | ||
| ClearCalc vs. Predicate Devices Electron MU and Dose Calculation | ||||
| Input | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters)data (Substantiallyequivalent) | Files/TreatmentPlanning SystemAPI-provided datacontaining CT,Structure Set, andTreatment Plan(includingtreatment fieldparameters) data | Files containingTreatment Plan(including treatmentfield parameters)data | N/A |
| Functionality | Utilize a library ofcustom cutouts andcomputes cutoutfactors using asector integrationmethod. Cutoutfactors may also beuser-entered. Usersmay alsosend/receive resultsfrom its monte carlodose calculationengine (branded asRadMonteCarlo),whereby the resultsare displayed inClearCalc forevaluation.(Substantiallyequivalent) | Utilize a library ofcustom cutoutsand computescutout factorsusing a sectorintegrationmethod. Cutoutfactors may alsobe user-entered. | Utilize a library ofcustom cutouts andcomputes cutoutfactors using asector integration orsquare root method.Cutout factors mayalso be user-entered.Users may alsosend/receive resultsfrom an eternal dosecalculation engine,whereby the resultsare displayed inRadCalc forevaluation. | N/A |
| Output | ClearCalc calculatesdose based onelectron field | ClearCalccalculates dosebased on electron | RadCalc calculatesdose based onelectron field | N/A |
| parameters andcutout geometry, anddisplays results forper-field MU and/ordose and provides adifference metric forevaluation in tabularformat and, whenapplicable, agenerated dosevolume histogram.(Substantiallyequivalent) | field parametersand cutoutgeometry, anddisplays results forper-field MUand/or dose andprovides adifference metricfor evaluation intabular format. | parameters andcutout geometry, anddisplays results forper-field MU and/ordose and provides adifference metric forevaluation in tabularformat. | ||
| ClearCalc vs. RadCalc Brachytherapy Dose Calculation | ||||
| Input | Files or TreatmentPlanning SystemAPI-provided datacontaining TreatmentPlan (includingsource positions anddwell times) data(Substantiallyequivalent) | Files or TreatmentPlanning SystemAPI-provided datacontainingTreatment Plan(including sourcepositions and dwelltimes) data | Files containingTreatment Plan(including sourcepositions and dwelltimes) data | N/A |
| Functionality | Utilizes the AAPMTG-43 protocol for itsbrachytherapy dosecalculations(Substantiallyequivalent) | Utilizes the AAPMTG-43 protocol forits brachytherapydose calculations | Utilizes the AAPMTG-43 protocol for itsbrachytherapy dosecalculations | N/A |
| Output | ClearCalc calculatesdose to arbitrarycalculation pointlocations andpresents differencemetrics comparingthe TPS dose vs.ClearCalc dose in atabular format.(Substantiallyequivalent) | ClearCalccalculates dose toarbitrarycalculation pointlocations andpresents differencemetrics comparingthe TPS dose vs.ClearCalc dose ina tabular format. | RadCalc calculatesdose to arbitrarycalculation pointlocations andpresents differencemetrics comparingthe TPS dose vs.RadCalc dose in atabular format. | N/A |
| Parameters | Subject Device:ClearCalc ModelRADCA V2 | Predicate Device:ClearCalc ModelRADCA | Predicate Device:RadCalc Version7.1 (K193381) | Predicate Device:myQA iON(K201798) |
| ClearCalc vs. myQA iON Proton MU and Dose Calculation | ||||
| Input | Files/TreatmentPlanning System | N/A | N/A | Files containingStructure Set, and |
| API-provided datacontaining CT,Structure Set, andTreatment Plan(including treatmentfield parameters)data (Minordifferences) | Treatment Plan(includingtreatment fieldparameters) data | |||
| Functionality | Sends/receives datafrom its monte carlodose calculationengine (branded asRadMonteCarlo) tocalculate protonplans from thenecessary files anddisplays the resultsto the user.(Substantiallyequivalent) | N/A | N/A | Sends/receivesdata from anexternal dosecalculation engineto calculate protonplans from thenecessary filesand displays theresults to the user. |
| Output | ClearCalc displaysthe dose resultsreceived from theRadMonteCarlo dosecalculation engineand allows the userto analyze the resultsin the UI.(Substantiallyequivalent) | N/A | N/A | myQA iONdisplays the doseresults receivedfrom the externaldose calculationengine and allowsthe user to analyzethe results in theUI. |
| ClearCalc vs. myQA iON Machine Treatment Log File Analysis | ||||
| Input | Files or TreatmentPlanning SystemAPI-provided datacontaining TreatmentPlan data as well asmachine log filesfrom a pre-treatmentor treatment session(Substantiallyequivalent) | N/A | N/A | Files containingTreatment Plandata as well asmachine log filesfrom apre-treatment ortreatment session |
| Functionality | Utilizes the machinelogs files toreconstruct thedelivered doseutilizing a dosecalculation from theset machineparameters. | N/A | N/A | Utilizes themachine logs filesto reconstruct thedelivered doseutilizing a dosecalculation from theset machineparameters. |
| (Substantiallyequivalent) | ||||
| Output | ClearCalc displaysthe log filecalculation result tothe user viadisplayed doseinformation andprovides a differencemetric for evaluation.(Substantiallyequivalent) | N/A | N/A | myQA iONdisplays the log filecalculation resultto the user viadisplayed doseinformation andprovides adifference metricfor evaluation. |
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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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.