Eclipse Treatment Planning System

K181145 · Varian Medical Systems, Inc. · MUJ · May 18, 2018 · Radiology

Device Facts

• Record ID: K181145
• Device Name: Eclipse Treatment Planning System
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: May 18, 2018
• 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 medical professionals to design and simulate radiation therapy treatments. It processes patient imaging data to plan external beam (photon, electron, proton) and brachytherapy treatments. The system supports advanced features including kV CBCT imaging, multi-layer beam shaping, dynamic beam flattening, and multi-isocenter field planning. It also includes specialized algorithms like Proton Eye for ocular neoplasms and RapidPlan for DVH estimation. The software assists clinicians in optimizing radiation dose distribution, which directly informs clinical decision-making for patient treatment. It is used in clinical settings by trained professionals to improve the precision and safety of radiation delivery.

Clinical Evidence

No clinical data or animal studies were provided. Substantial equivalence is supported by software verification and validation testing conducted in accordance with FDA guidance for software in medical devices.

Technological Characteristics

Computer-based software system for radiotherapy treatment planning. Conforms to IEC 62304 (software life cycle), IEC 62366-1 (usability), IEC 61217 (coordinates/movements), and IEC 62083 (TPS safety). Supports photon, electron, and proton beam planning. Features include kV CBCT integration, multi-layer beam shaping, and dynamic beam flattening. Software level of concern is major.

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. The Eclipse Proton Eye algorithm is indicated for planning proton treatment of neoplasms of the eye.

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 (K181145)

Submission Summary (Full Text)

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May 18, 2018

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

Re: K181145

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, 2018 Received: May 1, 2018

Dear Mr. Coronado:

We have reviewed vour 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 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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) K181145

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 style="border: 1px solid black;">☑</div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="border: 1px solid black;">☐</div> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### Varian Medical Systems

3100 Hansen Way Palo Alto, CA 94304

650.493.4000 800.544.4636

varian.com

# 510(k) Summary

[Information provided according to 21 CFR 807.92]

Image /page/3/Picture/7 description: The image is a document that contains information about the Eclipse Treatment Planning System v15.6. The document is divided into five sections: Submitter, Device, Predicate Device, Device Description, and Indications for Use/Intended Use Statement. The submitter is Varian Medical Systems, Inc. located in Palo Alto, California. The device is a treatment planning system used for planning radiotherapy treatments for patients with malignant or benign diseases.

Image /page/3/Picture/8 description: The image contains three blue circles arranged horizontally against a white background. The circles are evenly spaced and appear to be of the same size. The color of the circles is a bright, solid blue, and they are the only objects in the image.

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVI

Both the subject device and the predicate provide software the treatment of malignant or benign diseases with radiation. They are computer-based software devices used by trained medical professionals to design and simulate radiation therapy treatments. They are both capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.

The significant changes compared with the predicate device are as follows:

- a) Adding treatment planning support for Halcyon v2.0 features
- 1. Planning with kV CBCT imaging for Halcyon
- Planning with two-laver beam shaping (SX2 mode) for Halcyon MLC 2.
- Planning with dynamic beam flattening for Halcyon fields 3.
- Planning with long treatment field (multi-isocenter) 4.
- Machine configuration changes 5.

# b) Modifications to existing Eclipse features

- 1. Hybrid IMRT-VMAT plan creation change to Eclipse's MCO feature
- 2. DVH Estimation model export fix for Eclipse's RapidPlan feature

Treatment planning support for Halcyon is present in both the predicate device and subject device. The modifications to existing features are considered further developments of predicate features. The above changes do not affect the intended use of the Eclipse device. No Eclipse hardware requirement modifications are associated with these changes.

# VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

The subject device conforms in whole or in part with the following standards:

- . IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
- IEC 62366-1:2015, Medical Devices Part 1: Application of Usability Engineering to Medical Devices ●
- IEC 61217:2011, Radiotherapy Equipment - Coordinates, Movements, and Scales
- IEC 62083:2009, Medical Electrical Equipment Requirements for the Safety of Radiotherapy ● Treatment Planning Systems

No animal studies or clinical tests have been included with this pre-market submission.

# VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions. Varian therefore considers Eclipse Treatment Planning System v15.6 to have a similar level of safety and effectiveness as the predicate device.