(29 days)
No
The document describes a treatment planning software that simulates dose distribution based on user-defined parameters. There is no mention of AI, ML, or any learning or adaptive capabilities. The system relies on user input and pre-defined models, not data-driven algorithms.
No
The device is a treatment planning and analysis software for radiation therapy, which aids in administering treatments but does not directly apply or perform a therapeutic action on the patient.
No.
The device is a treatment planning and analysis software for radiation therapy, used to estimate dose distributions and set-up parameters for treatment. It does not diagnose medical conditions.
Yes
The device is described as a "software system" and a "planning tool" that provides simulations and analysis based on input parameters and CT scans. There is no mention of accompanying hardware components or hardware-specific functions beyond processing data for use with existing IORT devices.
Based on the provided information, Radiance V4 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Radiance V4 clearly states its purpose is for "treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy." It uses CT scans as input and provides dose distribution estimates for radiation treatment.
- The intended use is for planning and administering radiation therapy directly to the patient. This is a therapeutic application, not a diagnostic one that analyzes biological samples.
- The device description focuses on simulating dose distribution and adjusting parameters for treatment. This aligns with radiation therapy planning, not laboratory testing of specimens.
Therefore, Radiance V4 falls under the category of a medical device for radiation therapy planning, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The intended users of Radiance V4 shall be 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)
A Risk Analysis was performed according to ISO 14971:2007 and documentation was included in the 510(k) to assess the modifications and the impact on performance and safety.
The changes are included in requirement document and the design document is updated accordingly. Finally, the test cases are included or changed in test document to test the modifications. As a result, design verification testing was performed to assure the use of the changes was appropriate, safe and effective for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
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
1
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 and | |
| Classification 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 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. |
| DESCRIPTION OF DEVICE
MODIFICATIONS | The change(s) to the predicate Radiance V3 are as
follows:
Dose calculated in a volume orientated to the
applicator axis to improve accuracy of the dose in
the first millimeters to the applicator surface.
Calculation of water equivalent dose to be able to
introduce treatment parameters in the dose delivery
device software. |
| | 3. User data import/export functionality to exchange
data between radiance stations and to allow
backups. |
| | 4. Reconfiguration of the patients' database to give
more information to the user. |
| | 5. Improve the usability of the user interface and make
it available to be used in a touchscreen. |
| | 6. Synchronization with the device calibration directory
to avoid inconsistencies. |
| | 7. Check of computer resources (memory and hard
drive availability). |
| | 8. Include the capability to introduce several
calibration tables for different CT scans. |
| V. INDICATIONS FOR USE | Radiance V4 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 V4 shall be clinically
qualified radiation therapy staff trained in using the
system. |
| VI. COMPARISON OF
TECHNOLOGICAL | The Radiance V4 has the same intended use as the
predicate. |
| CHARACTERISTICS
WITH THE PREDICATE
AND REFERENCE
DEVICES | There are no fundamental technological differences
between the predicate and the modified device. The
only modification(s) are as noted. |
| | To address these differences, performance testing
was provided. |
| VI. SUMMARY OF
PERFORMANCE DATA
AND DESIGN
CONTROLS | A Risk Analysis was performed according to ISO
14971:2007 and documentation was included in the
510(k) to assess the modifications and the impact on
performance and safety. |
| | The changes are included in requirement document
and the design document is updated accordingly.
Finally, the test cases are included or changed in test
document to test the modifications. As a result, design
verification testing was performed to assure the use of |
4
5
| | the changes was appropriate, safe and effective for
the intended use. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VIII. CONCLUSION OF
SUBSTANTIAL
EQUIVALENCE | The information and data provided in this Special
510(k) establish that the modified device is
substantially equivalent in the intended use, design,
principle of operation, technology, materials,
specifications and performance to the predicate. |