ECLIPSE TREATMENT PLANNING SYSTEM

K141283 · Varian Medical Systems, Inc. · MUJ · Aug 7, 2014 · Radiology

Device Facts

• Record ID: K141283
• Device Name: ECLIPSE TREATMENT PLANNING SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Device Story

Eclipse TPS is a computer-based software tool for medical professionals to design and simulate radiation therapy. Inputs include patient medical images (CT, MR, PET) and clinical data. Software transforms inputs into treatment plans via dose calculation algorithms (e.g., AcurosXB, AcurosBV, Gaussian Pencil Beam, Monte Carlo) and optimization modules. Outputs include dose distributions, field parameters, and hardcopy reports for clinical review. Used in clinical settings by trained professionals to guide radiation delivery. Benefits include precise treatment planning, optimized dose delivery to target volumes, and sparing of healthy tissue. Supports integration with ARIA RadOnc and DICOM RT standards.

Clinical Evidence

Bench testing only. Verification and validation performed for new features and regression testing for existing features. System requirements traced to test outcomes. No safety-intolerable discrepancy reports remained.

Technological Characteristics

Software-based treatment planning system. Features include dose calculation algorithms (AcurosXB, AcurosBV, Monte Carlo, Gaussian Pencil Beam), image processing (segmentation, registration, blending), and optimization modules. Connectivity via DICOM RT and ARIA integration. Operates on standard clinical computing hardware. No specific materials or energy sources as it is a software device.

Indications for Use

Indicated for patients with malignant or benign diseases requiring radiotherapy. Includes external beam irradiation (photon, electron, proton) and internal irradiation (brachytherapy). Eclipse Proton Eye algorithm indicated for proton treatment of ocular neoplasms.

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

• Eclipse Treatment Planning System 13 (K133247)
• Eclipse Treatment Planning System 12 (K131891)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K141283

Trade/Device Name: Eclipse Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 30, 2014 Received: May 16, 2014

Dear Mr. Coronado:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
for

Janine M. Morris 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) K141283

Device Name Eclipse Treatment Planning System

#### Indications for Use (Describe)

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D'Hara

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# PREMARKET NOTIFICATION

# 510(k) Summary

# Eclipse Treatment Planning System

# As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado-Director Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Date: 30th April 2014 |
| Proprietary Name: | Eclipse Treatment Planning System |
| Classification Name: | system,planning,radiation therapy treatment<br>21CFR892.5050, MUJ, Class II |
| Common/Usual Name: | Eclipse TPS, Eclipse, Treatment Planning System. |
| Predicate Devices: | Eclipse Treatment Planning System 13 (K133247)<br>Eclipse Treatment Planning System 12 (K131891) |
| Device Description: | The Varian Eclipse™ Treatment Planning System (Eclipse TPS)<br>provides software tools for planning the treatment of malignant<br>or benign diseases with radiation. Eclipse TPS is a computer-based<br>software device used by trained medical professionals to<br>design and simulate radiation therapy treatments. Eclipse TPS is<br>capable of planning treatments for external beam irradiation with<br>photon, electron, and proton beams, as well as for internal<br>irradiation, (brachytherapy) treatments. |
| Indications for Use: | The Eclipse Treatment Planning System (Eclipse TPS) is used to<br>plan radiotherapy treatments for patients with malignant or<br>benign diseases. Eclipse TPS is used to plan external beam<br>irradiation with photon, electron and proton beams, as well as for<br>internal irradiation (brachytherapy) treatments. In addition, the<br>Eclipse Proton Eye algorithm is specifically indicated for<br>planning proton treatment of neoplasms of the eye. |

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#### Changes in Technological Characteristics:

The significant changes compared with the predicate are changes associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines.

The complete list of changes and their related requirements can be found in the document Tracing Changed/New Features to System Requirements in Section 18 of this submission.

#### Device Comparison Table

| | ECLIPSE TPS V12.0<br>(510(k) ID # K131891) | ECLIPSE TPS V13.0<br>(510(k) ID #K133247) | ECLIPSE TPS V13.5 |
|------------------------------------------------|--------------------------------------------|-------------------------------------------|-------------------|
| 2. General Usage | | | |
| External beam PHOTON<br>planning | yes | yes | yes |
| External beam PHOTON<br>inverse planning | yes | yes | yes |
| External beam ELECTRON<br>planning | yes | yes | yes |
| External beam PROTON<br>planning | yes | yes | yes |
| External beam OCULAR<br>PROTON planning (EOPP) | no | yes | yes |
| Internal BRACHYTHERAPY<br>planning | yes | yes | yes |
| Stereotactic Frame Localization | yes | yes | yes |
| 3. Supported External Beams<br>& Accessories | | | |
| Photon beams | yes | yes | yes |
| Electron beams | yes | yes | yes |
| Proton beams | yes | yes | yes |
| Coplanar fields | yes | yes | yes |
| Non-coplanar fields | yes | yes | yes |
| Multi-leaf Collimators | yes | yes | yes |
| Asymmetric collimators | yes | yes | yes |
| Stereotactic Cone collimators | yes | yes | yes |
| Arc fields | yes | yes | yes |
| Poured Blocks | yes | yes | yes |
| Compensators | yes | yes | yes |
| Physical wedges | yes | yes | yes |

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| Dynamic wedges | yes | yes | yes |
|---------------------------------------------------------------------|-----|-----|-----|
| Flattening filter free support<br>(FFF) | yes | yes | yes |
| Rotating treatment couch | yes | yes | yes |
| 4. Supported Brachytherapy<br>Sources & Accessories | | | |
| Plan for high dose rate<br>afterloader | yes | yes | yes |
| Manual low dose rate<br>brachytherapy: seeds, line<br>sources, wire | yes | yes | yes |
| Applicator library | yes | yes | yes |
| Needle templates | yes | yes | yes |
| Seed templates | no | no | yes |
| 5. Graphical User Interface | | | |
| Multiple-instance application | yes | yes | yes |
| Multiple-workspace layout | yes | yes | yes |
| Graphical display/editing of<br>field parameters | yes | yes | yes |
| Beam's-Eye-View display | yes | yes | yes |
| 3D patient image display | yes | yes | yes |
| Model for human Eye | yes | yes | yes |
| SRS Localization application | yes | yes | yes |
| SRS Planning application | yes | yes | yes |
| Biological Optimization<br>application | yes | yes | yes |
| Biological Evaluation<br>application | yes | yes | yes |
| 3D Conformal Optimization<br>application | yes | yes | yes |
| 6. Image Processing | | | |
| Orthogonal image displays (3) | yes | yes | yes |
| Oblique image display | yes | yes | yes |
| Edge enhancement filters | yes | yes | yes |
| Image smoothing filters | yes | yes | yes |
| CT/MR/PET Image Registration | yes | yes | yes |
| Image blending utility | yes | yes | yes |
| 4D image display (registration<br>of time series of 3D images) | yes | yes | yes |
| Digitally reconstructed<br>radiographs | yes | yes | yes |

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| Enclosed Volume<br>measurement | yes | yes | yes |
|-----------------------------------------------------------------------------------------------------------------------|--------------|--------------|--------------|
| Stereotactic Frame Coordinate<br>transformation | yes | yes | yes |
| 7. Image Segmentation | | | |
| Geometrical shapes | yes | yes | yes |
| Manual editing and<br>manipulation tools | yes | yes | yes |
| Automatic /semi-automatic<br>tools | yes | yes | yes |
| Automatic/semi-automatic on-<br>demand and post-processing<br>tools for individual<br>organs/structures | yes | yes | yes |
| 3D Automargin | yes | yes | yes |
| Logical operators | yes | yes | yes |
| Enhanced 2D and 3D<br>contouring tools | no | yes | yes |
| Enhanced 4D functionality,<br>including structure propagation<br>and display of respiratory<br>amplitude distribution | no | yes | yes |
| 8. Dose Calculation | | | |
| Distributed Calculation<br>Framework | yes | yes | yes |
| Photon calculation | yes | yes | yes |
| - Energy Range | 1 MV – 50 MV | 1 MV – 50 MV | 1 MV – 50 MV |
| - CT-based volumetric<br>calculation | yes | yes | yes |
| - Non-CT based IRREG<br>calculation | yes | yes | yes |
| - Convolution method | yes | yes | yes |
| - Combined electron/photon<br>scatter | yes | yes | yes |
| - Directional heterogeneity<br>correction | yes | yes | yes |
| - Treatment head modelling | yes | yes | yes |
| - Photon Monitor Unit<br>calculation | yes | yes | yes |
| - Compensator monitor unit<br>calculation | yes | yes | yes |
| - Beam Angle Optimization<br>(GEOS) | yes | yes | yes |

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| - Dose Dynamic Arc planning | yes | yes | yes |
|------------------------------------------------------|------------------|-----------------------------------------------------------|------------------|
| - Cone Dose Calculation | yes | yes | yes |
| - Biological optimization | yes | yes | yes |
| - 3D Conformal Optimization | yes | yes | yes |
| - IMRT optimization | yes | yes | yes |
| - AcurosXB dose calculation<br>algorithm | yes | yes | yes |
| - Range Uncertainty feature<br>for photons | no | yes | yes |
| - Siemens mArc | no | no | yes |
| Electron calculation | yes | yes | yes |
| - Energy Range | 1 MeV - 50 MeV | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| - Gaussian Pencil Beam Model | yes | yes | yes |
| - Electron Monte Carlo<br>algorithm | yes | yes | yes |
| - Electron Monitor Unit<br>calculation | yes | yes | yes |
| Proton calculation | yes | yes | yes |
| - Energy Range | 50 MeV - 300 MeV | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| - Single scattering technique | yes | yes | yes |
| - Double scattering technique | yes | yes | yes |
| - Uniform scanning technique | yes | yes | yes |
| - Modulated scanning<br>technique | yes | yes | yes |
| - Optimization for modulated<br>scanning | yes | yes<br>(new implementation<br>for<br>Proton Optimizer) | yes |
| - Monitor unit calculation for<br>modulated scanning | yes | yes | yes |
| - Range uncertainty feature<br>for Protons | yes | yes | yes |
| Brachytherapy calculation | yes | yes | yes |
| - AAPM TG 43 compliant | yes | yes | yes |
| - Point Dose calculation | yes | yes | yes |
| - Optimization to point dose<br>constraints | yes | yes | yes |
| - Geometric optimization | yes | yes | yes |
| - AcurosBV dose calculation<br>algorithm | yes | yes<br>(with support for<br>report the dose to<br>medium) | yes |

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| Eclipse Algorithm Application<br>Programming Interface (EAAPI) | yes | yes | yes |
|----------------------------------------------------------------|--------|----------------------------------------|----------------------------------------------------------------|
| RapidPlan - Dose Volume<br>Histogram (DVH) Estimation | yes | no | Yes<br>(extended Dose<br>Volume Histogram<br>(DVH) Estimation) |
| 9. Dose evaluation | | | |
| Dose color wash | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D | 3D |
| Reference point dose summary | yes | yes | yes |
| Dose Volume Histogram plot | yes | yes | yes |
| Plan summing tool | yes | yes | yes |
| Plan comparison tools | yes | yes | yes |
| Evaluation using biological<br>models | yes | yes | yes |
| 10. Plan Output - Hardcopy | | | |
| Graphics window screen dump | yes | yes | yes |
| Patient administration data | yes | yes | yes |
| Plan parameters | yes | yes | yes |
| Geometrical displays of plan<br>data | yes | yes | yes |
| Dose distribution | yes | yes | yes |
| DVH plot | yes | yes | yes |
| BEV display | yes | yes | yes |
| Patient orientation | yes | yes | yes |
| User Configurable hardcopy<br>layouts | yes | yes | yes |
| Import/Export<br>11.<br>Interfaces | | | |
| ARIA RadOnc integration | yes | yes | yes |
| DICOM RT | yes | yes | yes |
| Other image formats | yes | yes | yes |
| Electromagnetic Digitizer | import | import | import |
| Eclipse Scripting API (ESAPI)<br>read only access | yes | yes<br>(includes also<br>BrachyVision) | yes<br>(includes also<br>BrachyVision) |
| Eclipse Scripting API (ESAPI)<br>write access | no | yes<br>(in research database,<br>only) | yes<br>(in research database,<br>only) |

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| Export field coordinates to<br>Laser System | yes | export | export |
|------------------------------------------------|-----|--------|--------|
| Basic RT Prescription<br>information available | no | yes | yes |

### Non-clinical Testing

Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse. System requirements created or affected by the changes can be traced to the test outcomes.

### Conclusion of Non-Clinical testing

The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers Eclipse 13.5 to be safe and to perform at least as well as the predicate device.

### Argument for Substantial Equivalence to the Predicate Device

A subset of features of the current device is different to the predicate. Of these, the significant changes compared with the predicate are associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines. Other changes are the addition of new BrachyVision features.

These changes are all considered by Varian to be enhancements of the Indications for Use and the Intended Use remain unchanged. There are no changes in the principle of operation of the software. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes that Eclipse TPS is substantially equivalent to the predicate.