(65 days)
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
Radiance V2 is a treatment planning system, that is, 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 either manually or semi-automatically, 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 describes Radiance V2, a radiation treatment planning software, and its substantial equivalence to predicate devices, but it does not contain explicit acceptance criteria or a study proving that the device meets specific performance metrics.
However, it does mention validation and verification testing. Based on the available information, here's what can be extracted:
Acceptance Criteria and Device Performance
The document states that "Validation and Verification Testing carried out on the Radiance V2 indicates that it meets its predefined products requirements and requirements from the following product standards." However, the specific predefined product requirements (acceptance criteria) and the results showing how it met them (reported device performance) are not detailed in this summary.
The summary lists two standards that the device meets:
- IEC 61217: Radiotherapy equipment - Coordinates, movements and scales
- IEC 62083: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Without the specific product requirements, a table of acceptance criteria and reported performance cannot be generated directly from this document.
Study Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "The predecessor of Radiance V2 system, i.e., Radiance, has been tested clinically. This Clinical Study evaluated the effectiveness and repeatability of the planning process in IORT with Radiance in regard to the current modalities and the current uncertainties in regard to (manual) treatment planning."
- No sample size for the test set is provided.
- No data provenance (country of origin, retrospective/prospective) is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document. The clinical study mentioned refers to the "planning process" in IORT and comparison to "manual treatment planning," suggesting expert involvement, but details are not given.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- An MRMC study per se is not explicitly mentioned. The clinical study cited for Radiance (the predecessor) "evaluated the effectiveness and repeatability of the planning process... in regard to the current modalities and the current uncertainties in regard to (manual) treatment planning." This implies a comparison, but it's not described as an MRMC study with AI assistance in the way typically understood for diagnostic AI. The document does not specify any effect size of human reader improvement with/without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document focuses on "validation and verification testing" for the new features of Radiance V2 and states that the "computation algorithms and beam modeling tool" do not modify the basic functionality/workflow of the previous clinical study. This implies the core algorithms were tested, but whether a purely standalone performance evaluation (without any human review or interaction) was performed is not explicitly stated or detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document mentions the clinical study "evaluated the effectiveness and repeatability of the planning process... in regard to the current modalities and the current uncertainties in regard to (manual) treatment planning." This suggests that the "ground truth" for the predecessor's performance comparison was likely based on current clinical practice and manual treatment planning outcomes/judgments, but the specific definition (e.g., expert consensus on dose distribution accuracy, actual patient outcomes) is not detailed.
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The sample size for the training set:
- The document does not mention a separate training set or its sample size. The device is a "radiation treatment planning software" and the focus is on validation and verification against engineering requirements and a prior clinical study. This type of device typically uses physical models and measured data for beam modeling and dose calculation algorithm development, rather than a "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- As no training set is explicitly discussed in the context of machine learning, this information is not applicable/provided. The "ground truth" for dose calculation algorithms is usually established through highly accurate physical measurements (e.g., in water phantoms) and/or sophisticated Monte Carlo simulations. The document mentions "Beam modeling of the treatment unit based on relative measurements and output factors" as a feature.
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Premarket Notification: Traditional 510(k)
510(k) Summary
JAN 3 1 2014
| Submitter Name:Submitter Address: | GMV Soluciones Globales Internet S.A.U.Isaac Newton. 11; PTM Tres CantosMadrid 28760Spain | ||
|---|---|---|---|
| Phone Number:Fax Number: | 011 34 91 807 22 70011 34 91 807 21 99 | ||
| Contact Person: | Carlos Illana Alejandro | ||
| Date Prepared: | 14 November 2013 | ||
| Device Trade Name: | Radiance V2 | ||
| Common Name | Radiation Treatment Planning Software | ||
| Classification Name.Number &Product Code: | Medical charged-particle radiation therapy system21 CFR 892.5050MUJ | ||
| Predicate Devices: | K112060 | Radiancecleared 01/06/2012 | |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAMSPHERICAL APPLICATORSCleared 12/27/2012 | ||
| K102011 | Eclipse Treatment Planning SystemCleared 09/03/2010 | ||
| Device Descriptionand Statement ofIntended Use | Radiance V2 is a treatment planning system, that is, a softwareprogram for planning and analysis of radiation therapy plans.Typically, a treatment plan is created by importing patient imagesobtained from a CT scanner, defining regions of interest eithermanually or semi-automatically, deciding on a treatment setup andobjectives, optimizing the treatment parameters, comparingalternative plans to find the best compromise, computing theclinical dose distribution. approving the plan and exporting it. |
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Statement of Intended Use:
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval bv the intended user.
The system functionality can be configured hased on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
The technological characteristics are essentially the same as those
Summary of Technological Characteristics
of the predicate. All devices produce treatment plans with corresponding dose distributions computed using a three dimensional dosimetry engine. All devices have a function of electronic approval of
treatment plans by trained and authorized staff, and export in DICOM format for commencing treatment or archiving.
From the standpoint of both functionality and workflow the Radiance V2 device is substantially equivalent to the identified predicates as follows:
- · Within Radiance V2 and its predicates. Radiance and Eclipse. the user can adjust parameters to achieve a predicted outcome. rather than make a decision intra-operatively.
- · Radiance V2 and its predicates Radiance and Eclipse are designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with malignancies.
- · Radiance V2 and its predicates Radiance and Eclipse provide treatment plans with estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
- · Radiance V2 and its predicates Radiance and Eclipse use externally acquired medical images and user input to achieve the result.
The Radiance V2 dose distribution computation algorithm for the X-rav source of INTRA BEAM is equivalent to provided computation within INTRABEAM radiation treatment device
Substantial Equivalence
Section 5.0
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| itself.The added functionality of Radiance V2 versus Radiance issubstantial equivalent to other marketed predicate devices andtherefore there are no extra concerns on safety and efficacy of theproposed Radiance V2 device with respect to its predicates. | |
|---|---|
| Non Clinical Data | Validation and Verification Testing carried out on the RadianceV2 indicates that it meets its predefined products requirements andrequirements from the following product standards:• IEC 61217 Radiotherapy equipment - Coordinates,movements and scales• IEC 62083 Medical electrical equipment - Requirementsfor the safety of radiotherapy treatment planning systems |
| Clinical Data | The predecessor of Radiance V2 system, i.e., Radiance, has beentested clinically. This Clinical Study evaluated the effectivenessand repeatability of the planning process in IORT with Radiancein regard to the current modalities and the current uncertainties inregard to (manual) treatment planning. The changes in RadianceV2 (computation algorithms and beam modeling tool) do notmodify basic functionality/workflow in which that study wasperformed. Therefore the Clinical Study conducted for Radianceand data collected can be safely extrapolated and is also valid forRadiance V2, moreover all new design features have beensuccessfully validated ex-clinic. |
| Conclusion | The information discussed above demonstrates that the RadianceV2 device is substantially equivalent to the predicate device. |
| Declarations | • This summary includes only information that is also covered inthe body of the 510(k).• This summary does not contain any puffery or unsubstantiatedlabeling claims.• This summary does not contain any raw data, i.e., contains onlysummary data.• This summary does not contain any trade secret or confidentialcommercial information.• This summary does not contain any patient identificationinformation. |
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| Summary of Technical Characteristics | ||||
|---|---|---|---|---|
| Feature | Device RadianceV2 | Radiance | Eclipse | INTRABEAMSystem withINTRABEAMSphericalApplicators |
| 510(k)Number | K112060 | K102011 | K121653 | |
| Manufacturer | GMV SolucionesGlobales InternetS.A.U. | GMV Aerospaceand Defence S.A. | Varian MedicalSystems, Inc. | Carl ZeissMeditec AG |
| Classification# & ProductCode | 21 CFR 892.5050MUJ | 21 CFR 892.5050MUJ | 21 CFR 892.5050MUJ | 21 CFR 892.5900JAD |
| Indication foruse | Radiance V2 is asoftware systemintended fortreatmentplanning andanalysis ofintraoperativeradiation therapyadministeredwith devicessuitable forintraoperativeradiotherapy.The treatmentplans providetreatment unitset-up parametersand estimates ofdose distributionsexpected duringthe proposedtreatment, andmay be used toadministertreatments afterreview andapproval by theintended user.The systemfunctionality can | Radiance is asoftware systemintended fortreatmentplanning andanalysis ofintraoperativeradiation therapyby means ofelectron beams.The treatmentplans providetreatment unitset-up parametersand estimates ofdose distributionsexpected duringthe proposedtreatment, andmay be used toadministertreatments afterreview andapproval by theintended user.The systemfunctionality canbe configuredbased on userneeds. | The EclipseTreatmentPlanning System(Eclipse TPS) isused to planradiotherapytreatments forpatients withmalignant orbenign diseases.Eclipse TPS isused to planexternal beamirradiation withphoton, electronand protonbeams, as well asfor internalirradiation(brachytherapy)treatments. Inaddition, theEclipse ProtonEye algorithm isspecificallyindicated forplanning protontreatment ofneoplasms of theeye. | TheINTRABEAMSystem isintended to beused for radiationtherapytreatment. |
| be configuredbased on userneeds.The intendedusers of RadianceV2 shall beclinicallyqualifiedradiation therapystaff trained inusing the system. | The intendedusers of Radianceshall be clinicallyqualifiedradiation therapystaff trained inusing the system. | |||
| SystemDesign | Software only | Software only | Software only | Hardware andSoftware |
| Calculationfor electrons | Dosedistributionscomputed using athree dimensionaldose engine.Pencil Beamcomputation andMonte CarloComputation forelectrons | Dosedistributionscomputed using athree dimensionaldose engine.Pencil BeamComputation | Same forelectronsi.e. Pencil Beamcomputations andMonte CarloComputation forelectrons | Not applicable(X-ray device) |
| Calculationfor photons | Dose Painting(Planningcalculationinterpolation ofPDDmeasurements) | Not applicable | Not applicable | Calibration filesforINTRABEAM:PDD scaled withthe dose ratefactor for MUcomputation ofphotons |
| Input | Externallyacquired patientmedical imagesand user input.Calibration filesforINTRABEAM. | Same | Same | Calibration filesforINTRABEAM:MU/Gy factor +additional factors |
| Output | Treatment planswith | Same forelectrons | Same forelectrons | Monitor units |
| correspondingdose distributions | ||||
| Plan reviewand approval | Allows electronicapproval oftreatment plansby trained andauthorized staff | Same | Same | None |
| Dosecalculationalgorithmconfirmation | Algorithmsconfirmed for awide variety offield geometries,treatment units,treatment setupsand patientpositions,includingdifferent dosegrid resolutionsettings. | Same forelectrons | Same forelectrons | Same for MUcomputation |
| Beammodeling tool | Beam modelingof the treatmentunit based onrelativemeasurementsand outputfactors | None | Same | Not applicable |
:
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Premarket Notification: Traditional 510(k)
Section 5 Page 6 of 7
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K.133655
page 6of6
V2
Radiance V2 Premarket Notification: Traditional 510(k)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in a simple, abstract design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
GMV Soluciones Globales Internet S.A.U. % Ms. Debra Ferland Official Correspondent for GMV Oserve Group P.O. Box 940 CHARLESTOWN NH 03603
Re: K133655
Trade/Device Name: Radiance V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 25, 2013 Received: December 4, 2013
Dear Ms. Ferland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Ferland
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/RcportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133655
Device Name: Radiance V2
Indications For Use:
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Page 1 of 1
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k). K133655
§ 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.