Eclipse Treatment Planning System

K172163 · Varian Medical Systems, Inc. · MUJ · Aug 15, 2017 · Radiology

Device Facts

• Record ID: K172163
• Device Name: Eclipse Treatment Planning System
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, 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 used by trained medical professionals to design and simulate radiation therapy treatments. It ingests patient imaging data (CT, MR, PET) to facilitate treatment planning for external beam (photon, electron, proton) and internal (brachytherapy) radiation. The system provides tools for image registration, segmentation, dose calculation (including GPU-accelerated options), and plan evaluation. Clinicians use the output to design radiation delivery plans, which are then exported to treatment delivery systems. The device aids in optimizing dose distribution to target volumes while sparing healthy tissue, potentially improving treatment precision and patient outcomes. It operates within a clinical environment, integrating with systems like ARIA RadOnc via DICOM RT standards.

Clinical Evidence

Bench testing only. Verification and validation performed for all 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 GPU-calculation for optimization/dose, multi-criteria optimization (MCO), and knowledge-based contouring. Supports DICOM RT, ARIA integration, and scripting APIs (ESAPI). Algorithms include AcurosXB, AcurosPT, AcurosBV, and electron Monte Carlo. Operates on standard clinical computing hardware.

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 15.1.1 (K170969)

Reference Devices

• Smart Segmentation Knowledge Based Contouring (SS KBC) v2.2 (K141248)

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 15, 2017

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

Re: K172163

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: July 17, 2017 Received: July 19, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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'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)

### K172163

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):

| <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 15.1.1 (K170969). |
| 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 associated with:

- 1. Support for HyperArc Planning
- Support for Encompass Fixation Device (Encompass Structures for HyperArc) a.
- 2. Trade-Off Exploration based on Multi-Criteria Optimization (MCO)
- 3. GPU-calculation capability for select optimization and dose calculations
- 4. Updated handling for Numerical Input Values (NIV)
- 5. Inclusion of Smart Segmentation Knowledge Based Contouring (SS KBC) as an Eclipse module
- a. Updated Eclipse Image Registration and Segmentation IFU & Reference Guides

The complete list of Eclipse changes and their related requirements can be found in the document "Tracing Changed and New Features to System Requirements" in Section 18 of this submission; the indications for use and the intended use are the same in the subject device as for the predicate.

| | PREDICATE DEVICE<br>FEATURE/ SPECIFICATION<br>510(к) K170969<br>ECLIPSE TPS v15.1.1 | MODIFIED DEVICE<br>FEATURE/ SPECIFICATION<br>ECLIPSE TPS v15.5 |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Intended Use / Indications for Use | | |
| Statement of Intended Use and Indications for Use | Eclipse is intended to be used to plan radiotherapy<br>treatments for patients with malignant or benign<br>diseases. Eclipse is used to plan external beam<br>irradiation with photon, electron and proton beams,<br>as well as for internal irradiation (brachytherapy)<br>treatments. In addition, the Eclipse Proton Eye<br>algorithm is specifically indicated for planning proton<br>treatment of neoplasms of the eye. | Eclipse is intended to be used to plan radiotherapy<br>treatments for patients with malignant or benign<br>diseases. Eclipse is used to plan external beam<br>irradiation with photon, electron and proton beams,<br>as well as for internal irradiation (brachytherapy)<br>treatments. In addition, the Eclipse Proton Eye<br>algorithm is specifically indicated for planning proton<br>treatment of neoplasms of the eye. |
| 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 (Halcyon) | Yes | Yes |
| Automated Structure Delineation based on Expert<br>Case Library**) | No, feature was part of<br>Smart Segmentation<br>Knowledge Based<br>Contouring (v3.6) | Yes, feature is included<br>as a part of Eclipse<br>Treatment Planning<br>System (v15.5) |
| 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 |
| Rotating treatment couch | Yes | Yes |
| Non-rotating RDS couch | Yes | Yes |
| Elekta 160 MLC | Yes | Yes |
| Varian SX1 MLC | Yes | Yes |
| 4. Supported Brachytherapy Sources &<br>Accessories | | |
| Plan for high dose rate afterloader | Yes | Yes |
| 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…