Eclipse Treatment Planning System

K170969 · Varian Medical Systems, Inc. · MUJ · Jul 5, 2017 · Radiology

Device Facts

• Record ID: K170969
• Device Name: Eclipse Treatment Planning System
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jul 5, 2017
• 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 software-based treatment planning system used by trained medical professionals to design and simulate radiation therapy. It ingests patient imaging data (CT, MR, PET) to perform image registration, segmentation, and dose calculation. The system supports external beam (photon, electron, proton) and brachytherapy planning. It utilizes various algorithms (e.g., AcurosXB, AcurosPT, AAA, Monte Carlo) to calculate dose distributions, which are visualized via 2D/3D displays and dose-volume histograms (DVH). Clinicians use these outputs to optimize treatment plans, evaluate dose constraints, and generate hardcopy reports for clinical decision-making. The system integrates with ARIA RadOnc and supports DICOM RT standards. It facilitates clinical benefit by enabling precise, personalized radiation delivery planning, reducing potential harm to healthy tissue while targeting malignant or benign disease.

Clinical Evidence

Bench testing only. Verification and validation performed for new features and regression testing for existing features. Product conformed to user needs; no safety-intolerable discrepancy reports remained.

Technological Characteristics

Software-based treatment planning system. Operates on networked workstations. Supports DICOM RT, ARIA integration. Algorithms include AcurosXB, AcurosPT, AAA, Gaussian Pencil Beam, and Monte Carlo. Features include image segmentation, registration, and dose calculation for photon, electron, proton, and brachytherapy modalities.

Indications for Use

Indicated for patients with malignant or benign diseases requiring radiotherapy treatment planning, including external beam (photon, electron, proton) and internal (brachytherapy) irradiation. Includes specific indication for proton treatment of eye 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 13.7 (K152393)

Submission Summary (Full Text)

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Public Health Service

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

July 5, 2017

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

Re: K170969

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: June 7, 2017 Received: June 8, 2017

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

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forth in the quality systems (OS) 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. O'Hara

For

Robert 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)

### K170969

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) | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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, CA 94304<br>Contact Name: Peter J. Coronado-Director Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 13.7 (K152393). |
| 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:

- 1. Support for treatment planning for Varian RDS radiotherapy treatment units.
- 2. Scripting is enhanced to include Script Approval and Eclipse Automation.

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

| | PREDICATE DEVICE<br>FEATURE/SPECIFICATION<br>510(K) ID# K152393<br>ECLIPSE TPS v13.7 | MODIFIED DEVICE<br>FEATURE/SPECIFICATION<br>ECLIPSE TPS v15.1.1 |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 2. General Usage | | |
| External beam PHOTON planning | Yes | Yes |
| External beam PHOTON inverse planning | Yes | Yes |
| External beam ELECTRON planning | Yes | Yes |
| External beam PROTON planning | Yes | Yes |
| External beam OCULAR PROTON planning (EOPP) | No *) | No *) |
| Internal BRACHYTHERAPY planning | Yes | Yes |
| Stereotactic Frame Localization | Yes | Yes |
| Treatment Planning for Varian RDS | No | Yes |
| 3. Supported External Beams & Accessories | | |
| Photon beams | Yes | Yes |
| Electron beams | Yes | Yes |
| Proton beams | Yes | Yes |
| Coplanar fields | Yes | Yes |
| Non-coplanar fields | Yes | Yes |
| Multi-leaf Collimators | Yes | Yes |
| Asymmetric collimators | Yes | Yes |
| Stereotactic Cone collimators | Yes | Yes |
| Arc fields | Yes | Yes |
| Poured Blocks | Yes | Yes |
| Compensators | Yes | Yes |
| Physical wedges | Yes | Yes |
| Dynamic wedges | Yes | Yes |
| Flattening filter free support (FFF) | Yes | Yes |
| Elekta Versa HD (FFF) | Yes | Yes |
| Rotating treatment couch | Yes | Yes |
| Non-rotating RDS couch | No | Yes |
| Elekta Agility MLC 160 | Yes | Yes |
| Varian SX1 MLC | No | Yes |
| 4. Supported Brachytherapy Sources &<br>Accessories | | |
| Plan for high dose rate afterloader | Yes | Yes |
| | PREDICATE DEVICE<br>FEATURE/ SPECIFICATION<br>510(K) ID# K152393 | MODIFIED DEVICE<br>FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| Manual low dose rate brachytherapy: seeds, line<br>sources, wire | Yes | Yes |
| Applicator library | Yes | Yes |
| Needle templates | Yes | Yes |
| Seed templates | Yes | Yes |
| 5. Graphical User Interface | | |
| Multiple-instance application | Yes | Yes |
| Multiple-workspace layout | Yes | Yes |
| Graphical display/editing of field parameters | Yes | Yes |
| Beam's-Eye-View display | Yes | Yes |
| 3D patient image display | Yes | Yes |
| Model for human Eye | No *) | No *) |
| SRS Localization application | Yes | Yes |
| SRS Planning application | Yes | Yes |
| Biological Optimization application | Yes | Yes |
| Biological Evaluation application | Yes | Yes |
| 3D Conformal Optimization application | Yes | Yes |
| 6. Image Processing | | |
| Orthogonal image displays (3) | Yes | Yes |
| Oblique image display | Yes | Yes |
| Edge enhancement filters | Yes | Yes |
| Image smoothing filters | Yes | Yes |
| CT/MR/PET Image Registration | Yes | Yes |
| Image blending utility | Yes | Yes |
| 4D image display (registration of time series of 3D<br>images) | Yes | Yes |
| Digitally reconstructed radiographs | Yes | Yes |
| Enclosed Volume measurement | Yes | Yes |
| Stereotactic Frame Coordinate transformation | Yes | Yes |
| 7. Image Segmentation | | |
| Geometrical shapes | Yes | Yes |
| Manual editing and manipulation tools | Yes | Yes |
| Automatic /semi-automatic tools | Yes | Yes |
| Automatic/semi-automatic on-demand and post-<br>processing tools for individual organs/structures | Yes | Yes |
| Automatic on-demand and pre-processing tools for<br>multiple organs/structures | Yes | Yes |
| 3D Automargin | Yes | Yes |
| Logical operators | Yes | Yes |
| Enhanced 2D and 3D contouring tools | Yes | Yes |
| Enhanced 4D functionality, including structure<br>propagation and display of respiratory amplitude<br>distribution | Yes | Yes |
| 8. Dose Calculation | | |
| | PREDICATE DEVICE<br>FEATURE/ SPECIFICATION<br>510(k) ID# K152393 | MODIFIED DEVICE<br>FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| Distributed Calculation Framework | Yes | Yes |
| Photon calculation | Yes | Yes |
| - Energy Range | 1 MV - 50 MV | 1 MV - 50 MV |
| - CT-based volumetric calculation | Yes | Yes |
| - Non-CT based IRREG calculation | Yes | Yes |
| - Convolution method | Yes | Yes |
| - Combined electron/photon scatter | Yes | Yes |
| - Directional heterogeneity correction | Yes | Yes |
| - Treatment head modelling | Yes | Yes |
| - Photon Monitor Unit calculation | Yes | Yes |
| - Compensator monitor unit calculation | Yes | Yes |
| - Beam Angle Optimization (GEOS) | Yes | Yes |
| - Leaf Motion Sequencing | Yes | Yes |
| - Dose Dynamic Arc planning | Yes | Yes |
| - Cone Dose Calculation | Yes | Yes |
| - Biological optimization | Yes | Yes |
| - 3D Conformal Optimization | Yes | Yes |
| - IMRT optimization | Yes | Yes |
| - AcurosXB dose calculation algorithm | Yes | Yes |
| - AAA | Yes | Yes |
| - Range Uncertainty feature for photons | Yes | Yes |
| - Siemens mArc | Yes | Yes |
| - Siemens FFF (unflattened beam) | Yes | Yes |
| - Elekta Agility MLC 160 | Yes | Yes |
| - RaySearch PlanConverter | Yes | Yes |
| - Varian SX1 MLC | No | Yes |
| - FTDC Imaging dose calculation for RDS machine | No | Yes |
| Electron calculation | Yes | Yes |
| - Energy Range | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| - Gaussian Pencil Beam Model | Yes | Yes |
| - Electron Monte Carlo algorithm v2 | Yes<br>(including Siemens, Elekta) | Yes<br>(including Siemens, Elekta) |
| - Electron Monitor Unit calculation | Yes | Yes |
| - Portal Dose Image Prediction | Yes | Yes |
| Proton calculation | Yes | Yes |
| - Energy Range | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| - Single scattering technique | Yes | Yes |
| - Double scattering technique | Yes | Yes |
| | PREDICATE DEVICE<br>FEATURE/ SPECIFICATION<br>510(k) ID# K152393 | MODIFIED DEVICE<br>FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| - Uniform scanning technique | Yes | Yes |
| - Modulated scanning technique | Yes | Yes |
| - Optimization for modulated scanning | Yes | Yes |
| - Monitor unit calculation for modulated scanning | Yes | Yes |
| - Range uncertainty feature for Protons | Yes | Yes |
| - Robust Proton Optimization | Yes | Yes |
| - AcurosPT Dose Calculation Algorithm | Yes | Yes |
| Brachytherapy calculation | Yes | Yes |
| - AAPM TG 43 compliant | Yes | Yes |
| - Point Dose calculation | Yes | Yes |
| - Optimization to point dose constraints | Yes | Yes |
| - Geometric optimization | Yes | Yes |
| - AcurosBV dose calculation algorithm | Yes | Yes |
| | (with support for<br>report the dose to medium) | (with support for<br>report the dose to medium) |
| - Intermediate dose capability for AcurosBV algorithm | Yes | Yes |
| - Solid applicator model support | Yes | Yes |
| Eclipse Algorithm Application Programming<br>Interface (EAAPI) | Yes | Yes |
| RapidPlan - Dose Volume Histogram (DVH)<br>Estimation | Yes<br>(extended Dose Volume<br>Histogram (DVH)<br>Estimation) | Yes<br>(extended Dose Volume<br>Histogram (DVH)<br>Estimation) |
| 9. Dose evaluation | | |
| Dose color wash | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D |
| Reference point dose summary | Yes | Yes |
| Dose Volume Histogram plot | Yes | Yes |
| Plan summing tool | Yes | Yes |
| Plan comparison tools | Yes | Yes |
| Evaluation using biological models | Yes | Yes |
| 10. Plan Output - Hardcopy | | |
| Graphics window screen dump | Yes | Yes |
| Patient administration data | Yes | Yes |
| Plan parameters | Yes | Yes |
| Geometrical displays of plan data | Yes | Yes |
| Dose distribution | Yes | Yes |
| DVH plot | Yes | Yes |
| BEV display | Yes | Yes |
| Patient orientation | Yes | Yes |
| User Configurable hardcopy layouts | Yes | Yes |
| | PREDICATE DEVICE<br>FEATURE/ SPECIFICATION<br>510(k) ID# K152393 | MODIFIED DEVICE<br>FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| 11.<br>Import/Export Interfaces | | |
| ARIA RadOnc integration | Yes | Yes |
| DICOM RT | Yes | Yes |
| Other image formats | Yes | Yes |
| Electromagnetic Digitizer | Import | Import |
| Film Scanner | no | no |
| Eclipse Scripting API (ESAPI) read only access<br>(includes also BrachyVision<br>and Proton) | yes<br>(includes also BrachyVision<br>and Proton) | yes<br>(includes also BrachyVision<br>and Proton) |
| Eclipse Scripting API (ESAPI) write access<br>(in research database, only,<br>with additional proton<br>planning support) | Yes<br>(in research database, only,<br>with additional proton<br>planning support) | Yes<br>(in research database, only,<br>with additional proton<br>planning support) |
| Eclipse Automation | No | Yes |
| Export field coordinates to Laser System | export | export |
| Basic RT Prescription information available | Yes | Yes |

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* A compatible feature has not been released and using the feature is blocked either by not including it in the distribution media for the indicated version(s) or by licensing.

### 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 15.1.1 to be safe and effective 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 support for treatment planning for Varian RDS radiotherapy treatment units and Eclipse Automation.

These changes are all considered by Varian to be enhancements of the predicate. 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.