(232 days)
Radiance V5 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 V5 shall be clinically qualified radiation therapy staff trained in using the system.
Radiance V5 is a treatment simulation tool with faster Monte-Carlo simulation, multi-modal planning based on modern imaging standard for intraoperative radiotherapy (IORT). A software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest , deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
The provided text, a 510(k) summary for the Radiance V5 device, does not contain detailed information about the specific acceptance criteria and the study proving the device meets those criteria, particularly in the context of performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Substantial Equivalence: Arguing that Radiance V5 is substantially equivalent to its predicate device (Radiance V4, K171885).
- Technological Characteristics: Highlighting similarities in functionality and workflow, and noting improvements like faster Monte-Carlo simulation (GPU-based Hybrid Monte Carlo) and a redesigned UI.
- Non-Clinical Data: Stating that validation and verification testing indicated the device meets predefined product requirements and standards (IEC 61217, IEC 62083, IEC 62304, IEC 62366).
- Clinical Data (Limited): Referencing a clinical study performed for an even earlier predecessor (Radiance, K112060) to evaluate effectiveness and repeatability of the planning process in IORT. It then claims this data is safely extrapolatable to V5 because the changes in V5 do not modify basic functionality or workflow.
- Software V&V: Stating conformance with IEC 62304 and FDA guidance for software.
Crucially, the document does not provide a table of acceptance criteria with corresponding performance results for Radiance V5 itself, nor does it describe a study specifically designed to prove Radiance V5 meets quantitative performance metrics like those typically required for AI/ML-based diagnostic or treatment optimization tools (e.g., AUC, sensitivity, specificity, or error rates compared to ground truth).
The "Performance Data" section vaguely mentions "predefined products requirements" and "validation and verification testing" for non-clinical data, but does not elaborate on what these requirements or results were.
Given the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly detailed in quantitative, verifiable metrics (e.g., specific thresholds for dose accuracy, planning time, or UI usability scores). The document mentions meeting "predefined product requirements" and requirements from standards like IEC 61217, IEC 62083, IEC 62304, and IEC 62366. These standards typically cover aspects like safety, software lifecycle processes, usability engineering, and equipment-specific requirements, but do not necessarily define specific performance thresholds for a treatment planning algorithm's output accuracy against a clinical ground truth.
- Reported Device Performance: The document highlights improvements in "speed of the Hybrid Monte Carlo calculations" as a key performance enhancement over previous versions, making "less precise calculations unnecessary." It also states that validation and verification testing was "carried out on Radiance V5 indicates that it meets its predefined products requirements." No specific numerical performance data (e.g., accuracy, precision) are reported for Radiance V5's core treatment planning capabilities.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for Radiance V5. The document only references a clinical study for a predecessor (Radiance, K112060), but does not provide details about its sample size, data provenance (e.g., country of origin), or whether it was retrospective or prospective. It asserts that this prior study's data "can be safely extrapolated and is also valid for Radiance V5."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth for performance testing of Radiance V5 or its direct predecessor (V4). The "clinical study" mentioned for the even earlier Radiance (K112060) is vaguely described as evaluating "effectiveness and repeatability of the planning process," but details on ground truth establishment from experts are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This level of detail about test set design is not present in the document.
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:
- No MRMC study is detailed for Radiance V5. The document focuses on the device as a standalone treatment planning software that assists clinicians, rather than an AI that augments human interpretation in a diagnostic context requiring MRMC studies (which are more common for AI-assisted diagnostic imaging interpretation). The "clinical study" mentioned for the predecessor evaluated the "effectiveness and repeatability of the planning process," not human reading improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that non-clinical validation and verification testing was done on the software itself to ensure it met "predefined product requirements" and standards. This would effectively be a standalone performance evaluation against defined specifications, but the specifics of what was measured and how (e.g., dose calculation accuracy compared to a gold standard physics model) are not provided. The comparison of Monte Carlo calculations in V5 to less precise calculations in prior versions suggests an internal performance metric, but not a direct standalone clinical performance evaluation against a human or true outcome.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For a treatment planning system, ground truth would typically relate to the accuracy of dose calculations compared to a physics model or measurements, or the clinical efficacy and safety of the plans generated. The document only refers to the predecessor's study evaluating "effectiveness and repeatability of the planning process" and "current uncertainties in regard to (manual) treatment planning," which suggests a comparison to manual methods but doesn't define a specific ground truth.
8. The sample size for the training set:
- Not applicable as described. Radiance V5 is described as a "software program for planning and analysis of radiation therapy plans" with a "three dimensional dosimetry engine" and "Hybrid Monte Carlo dose computations." It's not presented as an AI/ML model that would typically have a distinct "training set" of patient data in the modern supervised learning sense. While it's software that performs complex calculations, the term "AI" is not explicitly used, and its "engine" implies a deterministic algorithm rather than a learned model requiring a training dataset.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, the device is not described as utilizing a training set in the AI/ML context. Its enhancements ("faster Monte-Carlo simulation," "redesigned user interface workflow," "multi-modal multi-image planning") appear to be engineering and algorithmic improvements rather than AI model training on a dataset with established ground truth.
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GMV Soluciones Globales Internet S.A.U. % Lorry Weaver Regulatory Consultant Qserve Group US, Inc. 350 S. Main Street, Suite 309 DOYLESTOWN, PA 18901
Re: K233236
Trade/Device Name: Radiance V5 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: September 28, 2023 Received: September 28, 2023
Dear Lorry Weaver:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
May 17, 2024
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding 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 mediation-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.
Loca Weidner
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
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Indications for Use
510(k) Number (if known) K233236
Device Name Radiance V5
Indications for Use (Describe)
Radiance V5 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 V5 shall be clinically qualified radiation therapy staff trained in using the system.
| 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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510(k) Summary
1. SUBMITTER
| Submitter Name: | GMV Soluciones Globales Internet S.A.U. |
|---|---|
| Submitter Address: | Isaac Newton, 11; PTM Tres CantosMadrid 28760Spain |
| Phone Number: | 011 34 91 807 22 70 |
| Fax Number: | 011 34 91 807 21 99 |
| Contact Person: | Carlos Illana Alejandro |
| Date Prepared: | 28 September 2023 |
2. DEVICE
| Device Trade Name: | Radiance V5 |
|---|---|
| Common Name: | Radiation Treatment Planning Software |
| Regulation Name: | Medical charged-particle radiation therapy system |
| Regulation Number: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| Device | System, Planning, Radiation Therapy Treatment |
3. PREDICATE DEVICE
Radiance V4 Predicate Devices: K171885
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. DEVICE DESCRIPTION
Radiance V5 is a treatment simulation tool with faster Monte-Carlo simulation, multi-modal planning based on modern imaging standard for intraoperative
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radiotherapy (IORT). A software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest , deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
5. INDICATIONS FOR USE
Radiance V5 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 V5 shall be clinically qualified radiation therapy staff trained in using the system.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| Summary ofTechnologicalCharacteristics | The technological characteristics are essentially the sameas those of the predicate.Both devices produce treatment plans with correspondingdose distributions computed using a three dimensionaldosimetry engine. Both devices have a function of electronicapproval of treatment plans by trained and authorized staff,and export in DICOM format for commencing treatment orarchiving. |
|---|---|
| SubstantialEquivalence | From the standpoint of both functionality and workflow theRadiance V5 device is substantially equivalent to theidentified predicate as follows:• Within Radiance V5 and its predicate Radiance V4, theuser can adjust parameters to achieve a predictedoutcome, rather than make a decision intra-operatively.• Radiance V5 and its predicate Radiance V4 are designedto analyze and plan radiation treatments in threedimensions for the purpose of treating patients withmalignancies.• Radiance V5 and its predicate Radiance V4 providetreatment plans with estimates of dose distributionsexpected during the proposed treatment and may be |
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used to administer treatments after review and approval by qualified medical personnel.
- · Radiance V5 and its predicate Radiance V4 use externally acquired medical images and user input to achieve the result.
Radiance V5 introduces a redesigned treatment planning user interface workflow and multi-modal multi-image planning. DICOM functionalities have been improved, and Hybrid Monte Carlo dose computations are now GPUbased for improved speed. These changes allow for improved usability of the software and improved simulation; however the dose distribution computation algorithms are identical to those implemented in Radiance V4 except dose painting and pencil beam calculations have been removed. These calculations were less accurate than Hybrid Monte Carlo but were able to be calculated faster. In Radiance V5 the speed of the Hybrid Monte Carlo calculations made these less precise calculations unnecessary.
7. PERFORMANCE DATA
| Non Clinical Data | Validation and Verification Testing carried out on Radiance V5 indicates that it meets its predefined products requirements and requirements from the following product standards:IEC 61217 Radiotherapy equipment - Coordinates, movements and scales IEC 62083 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems IEC 62304:2006 Medical device software – Software life cycle processes IEC 62366 Medical devices - Application of usability engineering to medical devices |
|---|---|
| Clinical Data | The predecessor of Radiance V5 system, i.e., Radiance – K112060, has been tested clinically. This Clinical Study evaluated the effectiveness and repeatability of the planning process in IORT (Intra-Operative Radio Therapy) with Radiance in regard to the current modalities and the current uncertainties in regard to (manual) treatment planning. The changes in Radiance V5 do not modify basic functionality/workflow in which that study was performed |
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Submitter: GMV Soluciones Globales Internet S.A.U.
| Therefore, the Clinical Study conducted for Radiance anddata collected can be safely extrapolated and is also validfor Radiance V5, moreover all new design features havebeen successfully validated in non-clinical tests. | |
|---|---|
| SoftwareVerification andValidation Testing | Radiance V5 was designed and developed in accordancewith IEC 62304 and as recommended by FDA's Guidance,"Content of Premarket Submissions for Device SoftwareFunctions". Radiance V5 was considered to fall into the |
8. CONCLUSION
The information discussed above demonstrates that the Radiance V5 device is substantially equivalent to the predicate device.
Enhanced Documentation category.
§ 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.