RADIANCE

K112060 · Gmv Aerospace and Defence S.A. · MUJ · Jan 6, 2012 · Radiology

Device Facts

• Record ID: K112060
• Device Name: RADIANCE
• Applicant: Gmv Aerospace and Defence S.A.
• Product Code: MUJ · Radiology
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams. 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 shall be clinically qualified radiation therapy staff trained in using the system.

Device Story

radiance is a software-only treatment planning system (TPS) for intraoperative radiation therapy (IORT) using electron beams. Input consists of externally acquired patient CT images and user-defined treatment objectives. The software allows clinicians to define regions of interest (manually or semi-automatically), set treatment parameters, and compute 3D dose distributions. The system outputs treatment plans containing unit set-up parameters and dose estimates. Used in clinical settings by qualified radiation therapy staff; the output is reviewed and approved by the clinician to guide treatment delivery. Benefits include optimized radiation delivery and improved clinical decision-making through pre-treatment dose analysis and plan comparison.

Clinical Evidence

No clinical data. Bench testing only. The device was validated through confirmation of dose calculation algorithms across a wide variety of field geometries, treatment units, treatment setups, and patient positions, including different dose grid resolution settings.

Technological Characteristics

Software-only treatment planning system. Computes 3D dose distributions using a 3D dosimetry engine. Connectivity via DICOM format for data import/export. Electronic approval workflow. Configurable functionality.

Indications for Use

Indicated for treatment planning and analysis of intraoperative radiation therapy (IORT) using electron beams. Intended for use by clinically qualified radiation therapy staff trained in the system.

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

• RayStation (K100552)

Reference Devices

• Eclipse (K102011)
• NOVAC7 (K990209)

Submission Summary (Full Text)

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radiance Premarket Notification: Traditional 510(k)

## 510(k) Summary

| Submitter Name: | GMV Aerospace and Defence S.A. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Isaac Newton, 11; PTM Tres Cantos<br>Madrid 28760<br>Spain |
| Phone Number: | 011 34 91 807 22 70 |
| Fax Number: | 011 34 91 807 21 99 |
| Contact Person: | Carlos Illana Alejandro |
| Date Prepared: | 15 July 2011 |
| Device Trade Name: | radiance |
| Common Name | Radiation Treatment Planning Software |
| Classification Name,<br>Number &<br>Product Code: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050<br>MUJ |
| Predicate Devices: | RayStation K100552 cleared 12 March 2010 |
| Device Description<br>and Statement of<br>Intended Use | radiance is a treatment planning system, that is, a software<br>program for planning and analysis of radiation therapy plans.<br>Typically, a treatment plan is created by importing patient images<br>obtained from a CT scanner, defining regions of interest either<br>manually or semi-automatically, deciding on a treatment setup and<br>objectives, optimizing the treatment parameters, comparing<br>alternative plans to find the best compromise, computing the<br>clinical dose distribution, approving the plan and exporting it. |
| | Statement of Intended Use: |
| | radiance is a software system intended for treatment planning and<br>analysis of intraoperative radiation therapy by means of electron<br>beams. |
| | The treatment plans provide treatment unit set-up parameters and<br>estimates of dose distributions expected during the proposed |

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| Summary of<br>Technological<br>Characteristics | The technological characteristics are essentially the same as those<br>of the predicate.<br>All devices produce treatment plans with corresponding dose<br>distributions computed using a three dimensional dosimetry<br>engine. All devices have a function of electronic approval of<br>treatment plans by trained and authorized staff, and export in<br>DICOM format for commencing treatment or archiving. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The radiance device is substantially equivalent to the RayStation<br>(K100552), with respect to technical and design features. The<br>submitted devices pose the same types of questions about safety or<br>effectiveness as the existing device. |
| Conclusion | The information discussed above demonstrates that the radiance<br>device is substantially equivalent to the predicate device. |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information. |

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| Feature | Device radiance | RayStation | Eclipse | NOVAC7 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | | K100552 | K102011 | K990209 |
| Manufacturer | GMV Aerospace<br>and Defence S.A. | RaySearch<br>Laboratories AB | Varian Medical<br>Systems, Inc. | HITESYS S.P.A. |
| Classification<br># & Product<br>Code | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5050<br>MUJ | 21 CFR 892.5050<br>IYE |
| Intended Use | radiance is a<br>software system<br>intended for<br>treatment<br>planning and<br>analysis of<br>intraoperative<br>radiation therapy<br>by means of<br>electron beams.<br><br>The treatment<br>plans provide<br>treatment unit<br>set-up parameters<br>and estimates of<br>dose distributions<br>expected during<br>the proposed<br>treatment, and<br>may be used to<br>administer<br>treatments after<br>review and<br>approval by the<br>intended user.<br><br>The system<br>functionality can<br>be configured<br>based on user<br>needs.<br><br>The intended<br>users of radiance<br>shall be clinically | RayStation is a<br>software system<br>designed for<br>treatment<br>planning and<br>analysis of<br>radiation therapy.<br><br>The treatment<br>plans provide<br>treatment unit<br>set-up parameters<br>and estimates of<br>dose distributions<br>expected during<br>the proposed<br>treatment, and<br>may be used to<br>administer<br>treatments after<br>review and<br>approval by the<br>intended user.<br><br>The system<br>functionality can<br>be configured<br>based on user<br>needs.<br><br>The intended<br>users of<br>RayStation shall<br>be clinically<br>qualified<br>radiation therapy | The Eclipse<br>Treatment<br>Planning System<br>(Eclipse TPS) is<br>used to plan<br>radiotherapy<br>treatments for<br>patients with<br>malignant or<br>benign diseases.<br>Eclipse TPS is<br>used to plan<br>external beam<br>irradiation with<br>photon, electron<br>and proton<br>beams, as well as<br>for internal<br>irradiation<br>(brachytherapy)<br>treatments. In<br>addition, the<br>Eclipse Proton<br>Eye algorithm is<br>specifically<br>indicated for<br>planning proton<br>treatment of<br>neoplasms of the<br>eye. | The NOVAC7 is<br>an electron linear<br>accelerator used<br>for radiation<br>therapy during<br>surgical<br>procedures in an<br>operating room<br>for the treatment<br>of malignant and<br>benign conditions.<br>Know as<br>intraoperative<br>radiation therapy<br>(IORT), this<br>technique allows<br>delivery of high<br>doses of radiation<br>directly aimed at<br>tumors or other<br>sites while<br>avoiding dosage<br>to surgically<br>mobilized normal<br>tissues.<br>The NOVAC7 is a<br>mobile and<br>articulated<br>machine that can<br>be moved towards<br>the patient and put<br>in the appropriate<br>position to carry<br>out the necessary<br>radiotherapy.<br>Applicators direct<br>the electron beam<br>to the surgical area<br>of interest |
| | qualified<br>radiation therapy<br>staff trained in<br>using the system. | staff trained in<br>using the<br>system. | | |
| System<br>Design | Software only | Same | Software only | Hardware and<br>Software |
| Calculation | Dose<br>distributions<br>computed using a<br>three dimensional<br>dose engine. | Same | Same for<br>electrons | Same for MU<br>computation |
| Input | Externally<br>acquired patient<br>medical images<br>and user input | Same | Same | Same for MU:<br>MU/Gy factor +<br>additional factors |
| Output | Treatment plans<br>with<br>corresponding<br>dose distributions | Same | Same for<br>electrons | Monitor units |
| Plan review<br>and approval | Allows electronic<br>approval of<br>treatment plans<br>by trained and<br>authorized staff | Same | Same | None |
| Dose<br>calculation<br>algorithm<br>confirmation | Algorithms<br>confirmed for a<br>wide variety of<br>field geometries,<br>treatment units,<br>treatment setups<br>and patient<br>positions,<br>including<br>different dose<br>grid resolution<br>settings. | | Same for<br>electrons | Same for MU<br>computation |

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## Summary of Technical Characteristics

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Document Control Room - WO
JAN - 6 2012

GMV Aerospace and Defence S.A. % Mr. William F. Greenrose Official Correspondant and Regulatory Consultant for GMV Aerospace and Defence S.A. Oserve America. Inc. 220 River Road CLAREMONT NH 03743-5647

· Re: K112060

Trade/Device Name: radiance Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: December 8, 2011 Received: December 13, 2011

Dear Mr. Greenrose:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be ferm mrketing your device as described in your Section 510(k) premarket will anow you to begin mainening your intilal equivalence of your device to a legally marketed nonthoution. The I Driven a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific at res see you Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Theos, promotions of the mart 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 Tou may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K112060 510(k) Number (if known):

radiance Device Name:

Indications For Use:

radiance is a software system intended for treatment planning and analysis of intraoperative radiation therapy by means of electron beams.

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 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 CDRH, Office of Device Evaluation (ODE)

Marn Pastil

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Office of In Vitro Diag

510K. K112060