Radiance V4

K171885 · Gmv Soluciones Globales Internet S.A.U. · MUJ · Jul 25, 2017 · Radiology

Device Facts

• Record ID: K171885
• Device Name: Radiance V4
• Applicant: Gmv Soluciones Globales Internet S.A.U.
• Product Code: MUJ · Radiology
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Radiance V4 is a software-based treatment planning system for intraoperative radiotherapy (IORT). It takes inputs including applicator geometry, orientation, patient positioning, and IORT device parameters to simulate 3D radiation dose distributions. The system calculates water-equivalent doses and provides treatment unit set-up parameters. Used by qualified radiation therapy staff in clinical settings, the software allows users to adjust parameters to predict outcomes prior to treatment. Output consists of treatment plans and dose distribution estimates, which are reviewed and approved by clinicians to guide radiation delivery. Benefits include improved treatment accuracy and pre-operative planning capabilities.

Clinical Evidence

Bench testing only. Design verification testing was performed to validate modifications, including risk analysis per ISO 14971:2007. No clinical data was required or provided.

Technological Characteristics

Software-based treatment planning system. Features include 3D dose distribution modeling, water-equivalent dose calculation, and touchscreen-compatible UI. Connectivity includes data import/export and synchronization with device calibration directories. System performs resource monitoring (memory/hard drive).

Indications for Use

Indicated for treatment planning and analysis of radiation therapy administered via intraoperative radiotherapy devices in cancer patients. Intended for use by clinically qualified radiation therapy staff.

Regulatory Classification

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.

Predicate Devices

• Radiance V3 (K153368)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------------------------|
| <span></span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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:<br>Telephone #: | Carlos Illana<br>[phone] |
| Date Prepared: | 23 June 2017 |
| II. DEVICE | |
| Device Trade Name: | Radiance V4 |
| Common and<br>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<br>radiotherapy (IORT), an application that provides a<br>simulation of the dose distribution according to the<br>parameters involved in the procedure. These<br>parameters in IORT include the geometry of the<br>applicator, its orientation and position with respect to<br>the patient and IORT device parameters.<br><br>Radiance V4 is designed to analyze and plan radiation<br>treatments in three dimensions for the purpose of<br>treating patients with cancer. The user can adjust<br>parameters to achieve a predicted outcome, rather than<br>make a decision intra-operatively. The created<br>treatment plans provide estimates of dose distributions<br>expected during the proposed treatment, and may be<br>used to administer treatments after review and<br>approval by qualified medical personnel. |
| DESCRIPTION OF DEVICE<br>MODIFICATIONS | The change(s) to the predicate Radiance V3 are as<br>follows:<br><br>1.<br>Dose calculated in a volume orientated to the<br>applicator axis to improve accuracy of the dose in<br>the first millimeters to the applicator surface.<br><br>2.<br>Calculation of water equivalent dose to be able to<br>introduce treatment parameters in the dose delivery<br>device software. |
| | 3. User data import/export functionality to exchange<br>data between radiance stations and to allow<br>backups. |
| | 4. Reconfiguration of the patients' database to give<br>more information to the user. |
| | 5. Improve the usability of the user interface and make<br>it available to be used in a touchscreen. |
| | 6. Synchronization with the device calibration directory<br>to avoid inconsistencies. |
| | 7. Check of computer resources (memory and hard<br>drive availability). |
| | 8. Include the capability to introduce several<br>calibration tables for different CT scans. |
| V. INDICATIONS FOR USE | Radiance V4 is a software system intended for<br>treatment planning and analysis of radiation therapy<br>administered with devices suitable for intraoperative<br>radiotherapy. |
| | The treatment plans provide treatment unit set-up<br>parameters and estimates of dose distributions<br>expected during the proposed treatment, and may be<br>used to administer treatments after review and<br>approval by the intended user. |
| | The system functionality can be configured based on<br>user needs. |
| | The intended users of Radiance V4 shall be clinically<br>qualified radiation therapy staff trained in using the<br>system. |
| VI. COMPARISON OF<br>TECHNOLOGICAL | The Radiance V4 has the same intended use as the<br>predicate. |
| CHARACTERISTICS<br>WITH THE PREDICATE<br>AND REFERENCE<br>DEVICES | There are no fundamental technological differences<br>between the predicate and the modified device. The<br>only modification(s) are as noted. |
| | To address these differences, performance testing<br>was provided. |
| VI. SUMMARY OF<br>PERFORMANCE DATA<br>AND DESIGN<br>CONTROLS | A Risk Analysis was performed according to ISO<br>14971:2007 and documentation was included in the<br>510(k) to assess the modifications and the impact on<br>performance and safety. |
| | The changes are included in requirement document<br>and the design document is updated accordingly.<br>Finally, the test cases are included or changed in test<br>document to test the modifications. As a result, design<br>verification testing was performed to assure the use of |

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| | the changes was appropriate, safe and effective for<br>the intended use. |
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| VIII. CONCLUSION OF<br>SUBSTANTIAL<br>EQUIVALENCE | The information and data provided in this Special<br>510(k) establish that the modified device is<br>substantially equivalent in the intended use, design,<br>principle of operation, technology, materials,<br>specifications and performance to the predicate. |