(29 days)
Radiance V4 is a software system intented 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 V4 shall be clinically qualified radiation therapy staff trained in using the system.
Radiance V4 is a planning tool for intraoperative radiotherapy (IORT), an application that provides a simulation of the dose distribution according to the parameters involved in the procedure. These parameters in IORT include the geometry of the applicator, its orientation and position with respect to the patient and IORT device parameters.
Radiance V4 is designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The user can adjust parameters to achieve a predicted outcome, rather than make a decision intra-operatively. The created treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
This document describes the Radiance V4, a software system for radiation therapy treatment planning. The device received 510(k) clearance (K171885) on July 25, 2017, from the FDA.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative format with corresponding reported device performance metrics. Instead, it describes a process of design verification testing to assure the changes were "appropriate, safe and effective for the intended use." The performance data is summarized as addressing the "modifications and the impact on performance and safety."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images. The testing described is "design verification testing" related to technical modifications of the software. Therefore, sample size and data provenance in terms of patient data are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The study focuses on design verification and technical performance rather than clinical performance based on expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not provided. As the testing is design verification, a clinical adjudication method would not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission is for a treatment planning software system, and the focus is on the software's ability to accurately calculate dose distributions and incorporate new features, not on improving human reader performance in diagnosis.
6. Standalone Performance
The primary function of Radiance V4 is a standalone planning tool. The "design verification testing" would inherently assess the algorithm's performance in calculating dose distributions and implementing the new features. However, specific standalone performance metrics (e.g., accuracy of dose calculation compared to a gold standard) are not quantitatively reported in this summary.
7. Type of Ground Truth Used
The "ground truth" for the design verification testing would likely involve:
- Technical specifications and requirements: Ensuring the software behaves according to its designed functionality.
- Physics-based models and simulations: Verifying the accuracy of dose calculations based on established radiation physics.
- Comparisons to established physical measurements (e.g., phantom measurements for dose distribution, though not explicitly stated as being performed here).
The document mentions that the changes include "improved accuracy of the dose in the first millimeters to the applicator surface" and "calculation of water equivalent dose." These imply a comparison against a known, accurate dose distribution or calculation method.
8. Sample Size for the Training Set
No information about a "training set" is provided. As a treatment planning software, it's not a machine learning model that requires a labeled dataset for training in the conventional sense. The development would involve engineering and physics principles rather than AI training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2017
GMV Soluciones Globales Internet S.A.U. % Patsy Trisler Jd, Rac Consultant Oserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, Maryland 20815
Re: K171885
Trade/Device Name: Radiance V4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: June 23, 2017 Received: June 26, 2017
Dear Patsy Trisler Jd, Rac:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education 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.
Michael D. D'Hara For
Robert A. Ochs, Ph.D. 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) K171885
Device Name Radiance V4
Indications for Use (Describe)
Radiance V4 is a software system intented 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 V4 shall be clinically qualified radiation therapy staff trained in using the system.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY – Radiance V4
| I. SUBMITTER | |
|---|---|
| Submitter Name: | GMV Soluciones Globales Internet S.A.U. |
| Submitter Address: | Isaac Newton, 11. 28760, Tres Cantos. Madrid, Spain |
| Contact Person:Telephone #: | Carlos Illana+34 918072100 |
| Date Prepared: | 23 June 2017 |
| II. DEVICE | |
| Device Trade Name: | Radiance V4 |
| Common andClassification Name(s): | Medical charged-particle radiation therapy system |
| Classification #: | 21 CFR 892.5050 |
| Product Code | MUJ |
| Regulatory Class | 2 |
| Review Panel | Radiology |
| III. PREDICATE DEVICE | K153368, Radiance V3 |
| IV. DEVICE DESCRIPTION | Radiance V4 is a planning tool for intraoperativeradiotherapy (IORT), an application that provides asimulation of the dose distribution according to theparameters involved in the procedure. Theseparameters in IORT include the geometry of theapplicator, its orientation and position with respect tothe patient and IORT device parameters.Radiance V4 is designed to analyze and plan radiationtreatments in three dimensions for the purpose oftreating patients with cancer. The user can adjustparameters to achieve a predicted outcome, rather thanmake a decision intra-operatively. The createdtreatment plans provide estimates of dose distributionsexpected during the proposed treatment, and may beused to administer treatments after review andapproval by qualified medical personnel. |
| DESCRIPTION OF DEVICEMODIFICATIONS | The change(s) to the predicate Radiance V3 are asfollows:1.Dose calculated in a volume orientated to theapplicator axis to improve accuracy of the dose inthe first millimeters to the applicator surface.2.Calculation of water equivalent dose to be able tointroduce treatment parameters in the dose deliverydevice software. |
| 3. User data import/export functionality to exchangedata between radiance stations and to allowbackups. | |
| 4. Reconfiguration of the patients' database to givemore information to the user. | |
| 5. Improve the usability of the user interface and makeit available to be used in a touchscreen. | |
| 6. Synchronization with the device calibration directoryto avoid inconsistencies. | |
| 7. Check of computer resources (memory and harddrive availability). | |
| 8. Include the capability to introduce severalcalibration tables for different CT scans. | |
| V. INDICATIONS FOR USE | Radiance V4 is a software system intended fortreatment planning and analysis of radiation therapyadministered with devices suitable for intraoperativeradiotherapy. |
| The treatment plans provide treatment unit set-upparameters and estimates of dose distributionsexpected during the proposed treatment, and may beused to administer treatments after review andapproval by the intended user. | |
| The system functionality can be configured based onuser needs. | |
| The intended users of Radiance V4 shall be clinicallyqualified radiation therapy staff trained in using thesystem. | |
| VI. COMPARISON OFTECHNOLOGICAL | The Radiance V4 has the same intended use as thepredicate. |
| CHARACTERISTICSWITH THE PREDICATEAND REFERENCEDEVICES | There are no fundamental technological differencesbetween the predicate and the modified device. Theonly modification(s) are as noted. |
| To address these differences, performance testingwas provided. | |
| VI. SUMMARY OFPERFORMANCE DATAAND DESIGNCONTROLS | A Risk Analysis was performed according to ISO14971:2007 and documentation was included in the510(k) to assess the modifications and the impact onperformance and safety. |
| The changes are included in requirement documentand the design document is updated accordingly.Finally, the test cases are included or changed in testdocument to test the modifications. As a result, designverification testing was performed to assure the use of |
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| the changes was appropriate, safe and effective forthe intended use. | |
|---|---|
| VIII. CONCLUSION OFSUBSTANTIALEQUIVALENCE | The information and data provided in this Special510(k) establish that the modified device issubstantially equivalent in the intended use, design,principle of operation, technology, materials,specifications and performance to the predicate. |
§ 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.