ECLIPSE TREATMENT PLANNING SYSTEM

K131891 · Varian Medical Systems, Inc. · MUJ · Sep 25, 2013 · Radiology

Device Facts

• Record ID: K131891
• Device Name: ECLIPSE TREATMENT PLANNING SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Sep 25, 2013
• 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 for patients 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 12 is a software-based treatment planning system (TPS) for radiation therapy. It processes medical images to design and simulate external beam (photon, electron, proton) and internal (brachytherapy) radiation treatments. Operated by trained medical professionals in clinical settings, the system utilizes various dose calculation algorithms (e.g., AcurosXB, AcurosBV, PRO, BAO, DVO) to generate treatment plans. It integrates with hospital infrastructure via SQL Server, supporting RT prescription, plan validation, and status tracking. The software provides tools for image segmentation, dose-volume histogram (DVH) estimation, and modulated scanning for proton therapy. Clinicians use the output to finalize radiation delivery parameters, aiming to optimize dose distribution to target tissues while sparing healthy anatomy. The system supports remote deployment and utilizes the Eclipse Scripting API for workflow integration.

Clinical Evidence

No clinical data. Evidence consists of non-clinical verification and validation testing performed on a production-equivalent device under clinically representative conditions to confirm design input requirements and functional integrity.

Technological Characteristics

Software-based TPS; 64-bit architecture. Algorithms: AcurosXB, AcurosBV, PRO, BAO, DVO, and fluence calculation via LMC. Connectivity: SQL Server database, Eclipse Scripting API (ESAPI), DICOM-compatible. Features: Deformable registration (SmartAdapt), DVH estimation, modulated proton scanning (spot/line), and support for various linac platforms (TrueBeam, Elekta VMAT).

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). 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 (K102011)

Submission Summary (Full Text)

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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 3100 Hansen Way, m/s E110 Palo Alto CA94304

Contact Name: Peter J. Coronado Phone: [phone] Fax:[phone] Date: 21 June 2013

Eclipse Treatment Planning System

Proprietary Name:

Classification Name:

Common/Usual Name:

Predicate Devices:

Device Description:

Indications for Use:

system,planning,radiation therapy treatment 21CFR892.5050, MUJ, Class II

Eclipse, TPS, Eclipse TPS, Eclipse 12, Eclipse 12 TPS, Eclipse TPS 12.

Eclipse Treatment Planning System (K102011)

The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.

The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients 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.

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## Changes in Technological Characteristics:

| FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED<br>DEVICE | CLEARED DEVICE<br>FEATURE/SPECIFICATION<br>(ECLIPSE 10- K102011) | DEVICE WITH CHANGE<br>ECLIPSE 12 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Supported<br>External Beams<br>& Accessories | • TrueBeam support | • TrueBeam support |
| Graphical User<br>Interface | • Nexus Phase 0 - Home<br>screen integration and<br>navigation not present | • Nexus Phase 0- Home screen integration<br>and navigation |
| Image<br>Segmentation | • Automatic on-demand<br>and pre-processing tools<br>for multiple<br>organs/structures | • No Automatic on-demand and pre-<br>processing tools for multiple<br>organs/structures<br>(SmartAdapt) toolset utilizing changed CT-<br>MR and MR-MR deformable registration |
| Dose<br>Calculation | • Photon calculation<br>○ RapidArc:<br>intermediate<br>dose calculation<br>○ RapidArc: Varian<br>linac and support<br>○ FFF support for<br>TrueBeam | • Photon calculation<br>○ RapidArc: enhancements in<br>intermediate dose calculation<br>○ IMRT: intermediate dose<br>calculation<br>○ RapidArc Varian linac, and Elekta<br>VMAT support<br>○ FFF: Support for C3 and<br>TrueBeam<br>• Dose-Volume Histogram (DVH) Estimation |
| | • Proton calculation<br>○ Modulated<br>scanning (spot<br>scanning)<br>technique<br>○ Spot editor | • Proton calculation<br>○ Modulated scanning technique<br>(spot and line scanning), support<br>block and MLC<br>○ Range uncertainty feature<br>○ Spot editor user interface<br>improvements<br>○ Dosimetrically equivalent<br>treatment units (for different<br>gantries)<br>○ Block drill bit corrections for<br>milling machines |
| | • Brachytherapy calculation<br>○ AcurosBV dose<br>calculation<br>algorithm<br>○ AcurosBV<br>calculates dose to<br>transport media<br>but reports it in<br>water | • Brachytherapy calculation<br>○ AcurosBV dose calculation<br>algorithm in 64 bit environment<br>○ AcurosBV calculates does to<br>transport media<br>○ Nexus phase 0 support |
| FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED<br>DEVICE | CLEARED DEVICE<br>FEATURE/SPECIFICATION<br>(ECLIPSE 10- K102011) | DEVICE WITH CHANGE<br>ECLIPSE 12 |
| | 64 bit External Beam<br>Planning, BrachyVision<br>and Proton, PRO and<br>AcurosXB algorithms Fluence calculation by<br>LMC algorithm | 64 bit External Beam Planning,<br>BrachyVision and Proton, PRO, AcurosXB<br>AcurosBV and BAO & DVO algorithms and<br>DVH Estimation. Unified fluence calculation in Eclipse &<br>DCF by the final 3D dose calculation<br>algorithm |
| Import/Export<br>Interfaces | Film Scanner import | No Film Scanner import Eclipse Scripting API (ESAPI) read only<br>access |
| Infrastructure | Sybase Server | SQL Server migration Zero Clinical Downtime: Faster DB<br>upgrades Zero Clinical Downtime: Remote<br>deployment of the clients Nexus Phase 0 RT Prescription integration Plan validation and status change<br>service Dosimetrically Equivalent<br>machine change service Approval modifications |

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and the commend of the comments of the country

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K131891
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#### Summary of Non-clinical Testing

Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.

Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.

#### Conclusion of Non-Clinical testing

Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers Eclipse 12 to be safe and to perform at least as well as the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contral Center - WO66-Gold Silver Spring, MI) 20993-0002

September 25, 2013

DEPARTMENT OF HEALTH & HUMAN SERVICES

Varian Medical Systems. Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Wav, M/S E110 PALO ALTO CA 94303

Re: K131891

Trade/Device Name: Eclipse 12 Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system. Regulatory Class: 11 Product Code: MUJ, L.HN Dated: June 21, 2013 Received: June 28, 2013

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 Amendnents, 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.

ff 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 I hat FDA has made a determination that your device complies with other requirements of the Act mar + Breaks intact and regulations administered by other Federal agencies. You must or any 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 (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.

Image /page/4/Picture/11 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The figure is positioned to the right of a circular arrangement of text, which appears to be a company name or slogan. The logo is simple, using only black lines on a white background, giving it a clean and modern look.

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Page 2-Mr. Coronado

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Mechal D. Offara

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): K131891

Eclipse 12 Treatment Planning System Device Name:

Indications for Use:

The Eclipse Treatment Planning System (Eclipse TPS) Is used to plan radiotherapy treatments for patients 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K 131891

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