(232 days)
No reference devices were used in this submission.
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning functionalities like Monte-Carlo simulation and image-based planning.
No
This device is a software system for planning and analysis of radiation therapy, not a device that directly administers treatment or provides a therapeutic effect. It supports the administration of treatment by providing information for treatment planning.
No
Explanation: The device is described as a "treatment simulation tool" and a "software system intended for treatment planning and analysis of radiation therapy." It helps in creating treatment plans, optimizing parameters, and computing dose distributions for radiation therapy, which are functions related to treatment and not diagnosis.
Yes
The device description explicitly states "A software program for planning and analysis of radiation therapy plans." While it interacts with external hardware (CT scanners, radiation therapy devices), the device itself, as described, is solely the software system. The validation and verification testing also focuses on software standards (IEC 62304).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Radiance V5's Intended Use: The intended use of Radiance V5 is for treatment planning and analysis of radiation therapy. It uses patient images (from a CT scanner) to simulate and plan radiation treatment, not to analyze biological specimens.
- Device Description: The description reinforces this by stating it's a "treatment simulation tool" and a "software program for planning and analysis of radiation therapy plans."
Therefore, Radiance V5 falls under the category of medical devices used for treatment planning and delivery, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
MUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner, externally acquired medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinically qualified radiation therapy staff trained in using the system.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Therefore, the Clinical Study conducted for Radiance and data collected can be safely extrapolated and is also valid for Radiance V5, moreover all new design features have been successfully validated in non-clinical tests.
Software Verification and Validation Testing: Radiance V5 was designed and developed in accordance with IEC 62304 and as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions". Radiance V5 was considered to fall into the Enhanced Documentation category.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 Cantos |
| Madrid 28760 | |
| Spain | |
| 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
4
2 of 4
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 of
Technological
Characteristics | The technological characteristics are essentially the same
as those of the predicate.
Both devices produce treatment plans with corresponding
dose distributions computed using a three dimensional
dosimetry engine. Both 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. |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | From the standpoint of both functionality and workflow the
Radiance V5 device is substantially equivalent to the
identified predicate as follows:
• Within Radiance V5 and its predicate Radiance V4, the
user can adjust parameters to achieve a predicted
outcome, rather than make a decision intra-operatively.
• Radiance V5 and its predicate Radiance V4 are designed
to analyze and plan radiation treatments in three
dimensions for the purpose of treating patients with
malignancies.
• Radiance V5 and its predicate Radiance V4 provide
treatment plans with estimates of dose distributions
expected during the proposed treatment and may be |
5
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 |
6
Submitter: GMV Soluciones Globales Internet S.A.U.
| | Therefore, the Clinical Study conducted for Radiance and
data collected can be safely extrapolated and is also valid
for Radiance V5, moreover all new design features have
been successfully validated in non-clinical tests. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Verification and
Validation Testing | Radiance V5 was designed and developed in accordance
with IEC 62304 and as recommended by FDA's Guidance,
"Content of Premarket Submissions for Device Software
Functions". 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.