Eclipse Treatment Planning System

K152393 · Varian Medical Systems, Inc. · MUJ · Sep 18, 2015 · Radiology

Device Facts

• Record ID: K152393
• Device Name: Eclipse Treatment Planning System
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Special
• 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 system used by trained medical professionals to design and simulate radiation therapy treatments. It processes patient imaging data (CT, MR, PET) to plan external beam (photon, electron, proton) and internal (brachytherapy) radiation. The system includes tools for image registration, segmentation, dose calculation, and optimization. New features include Acuros PT (Monte Carlo-based proton dose calculation), Field Specific PTV for proton planning, and Acuros BV intermediate dose calculation for brachytherapy. The software assists clinicians in creating treatment plans, which are then used to guide radiation delivery equipment. By providing accurate dose distribution modeling and optimization, the device helps clinicians maximize radiation delivery to target tissues while sparing healthy structures, potentially improving therapeutic outcomes for patients with malignant or benign diseases.

Clinical Evidence

Bench testing only. Verification and validation were performed for all new features, with regression testing against existing features. Testing confirmed conformance to user needs and intended uses with no safety-intolerable discrepancy reports.

Technological Characteristics

Software-based treatment planning system. Features Monte Carlo-based dose calculation (Acuros PT), volumetric optimization, and image processing (registration, segmentation). Supports photon (1-50 MV), electron (1-50 MeV), and proton (50-300 MeV) beams. Integrates with ARIA RadOnc and supports DICOM RT standards. Operates on a distributed calculation framework.

Indications for Use

Indicated for patients with malignant or benign diseases requiring radiotherapy. Used for planning external beam irradiation (photon, electron, proton) and internal irradiation (brachytherapy). Eclipse Proton Eye algorithm indicated for proton treatment planning 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 13.5 (K141283)

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

September 18, 2015

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

Re: K152393

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: August 21, 2015 Received: August 26, 2015

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 Industry and Consumer Education at its toll-free 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 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 yours.

Michael D'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) K152393

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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## 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<br>Contact Name: Peter J. Coronado-Director Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Date:21st August 2015 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 13.5 (K141283). |
| 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. Addition of Acuros PT- a new Monte Carlo based dose calculation algorithm for Proton Planning
- Field Specific PTV- a new tool in proton planning for creating field-specific target volumes based on 2. field and patient geometries and proton planning uncertainties
- 3. Acuros BV Intermediate dose calculation added to volumetric optimizer-Optimization
- a. takes into account image and applicator material heterogeneities.
- b. Includes Optimizer convergence detection.

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

| | CLEARED DEVICE FEATURE/<br>SPECIFICATION | MODIFIED DEVICE FEATURE/<br>SPECIFICATION |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | |
| | 510(k) ID# K141283 | |
| | ECLIPSE TPS 13.5 NLS & MR1 | ECLIPSE TPS v13.7 |
| 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<br>(EOPP) | Yes | No |
| Internal BRACHYTHERAPY planning | Yes | Yes |
| Stereotactic Frame Localization | Yes | Yes |
| 3. Supported External Beams &<br>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 |
| Rotating treatment couch | Yes | Yes |
| Elekta 160 MLC | Yes | Yes |
| 4. Supported Brachytherapy Sources &<br>Accessories | | |
| Plan for high dose rate afterloader | Yes | Yes |
| Manual low dose rate brachytherapy: seeds,<br>line 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 | Yes | 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<br>of 3D 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<br>post-processing tools for individual<br>organs/structures | Yes | Yes |
| Automatic on-demand and pre-processing<br>tools for multiple organs/structures | No | No |
| 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<br>amplitude distribution | Yes | Yes |
| 8. Dose Calculation | | |
| 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 |
| - Range Uncertainty feature for photons | Yes | Yes |
| - Siemens mArc | Yes | Yes |
| - RaySearch PlanConverter | 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 | Yes | Yes (including Siemens,<br>Elekta) |
| - Electron Monitor Unit calculation | 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 |
| - Uniform scanning technique | Yes | Yes |
| - Modulated scanning technique | Yes | Yes |
| - Optimization for modulated scanning | yes | Yes |
| - Monitor unit calculation for modulated<br>scanning | Yes | Yes |
| - Range uncertainty feature for Protons | Yes | Yes |
| - Robust Proton Optimization | No | Yes |
| - AcurosPT Dose Calculation Algorithm | No | Yes |
| <b>Brachytherapy calculation</b> | <b>Yes</b> | <b>Yes</b> |
| - 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 |
| - Intermediate dose capability for AcurosBV<br>algorithm | No | 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) Estimation) | Yes<br>(extended Dose Volume<br>Histogram (DVH) 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 |
| 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<br>access | yes<br>(includes also BrachyVision) | yes<br>(includes also BrachyVision<br>and Proton) |
| Eclipse Scripting API (ESAPI) write access | yes<br>(in research database, only) | Yes<br>(in research database, only,<br>with additional proton planning<br>support) |
| 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 13.7 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 Acuros Proton Therapy, Field Specific PTV and Acuros BV intermediate dose calculation to volumetric optimizer.

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.