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 Description

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment for a device. Instead, it describes a premarket notification for the "Eclipse 12 Treatment Planning System," focusing on its features, intended use, and substantial equivalence to a predicate device.

The document states that "Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements" and "Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel." However, it does not provide the specifics of these tests, such as:

Quantitative acceptance criteria for performance metrics (e.g., accuracy thresholds, precision values).
Specific study designs (e.g., retrospective, prospective).
Sample sizes for test or training sets.
Data provenance (country, type of data).
Number and qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies or their effect sizes.
Standalone algorithm performance details.
Type of ground truth used (e.g., pathology, outcomes).
How ground truth was established for training data.

Without this specific information, it is not possible to complete the requested table or describe the study in detail. The document is a regulatory submission summary, not a technical report detailing the validation studies.

Summary

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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: 650/424.6230 Fax:650/842.5040 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 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/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	CLEARED DEVICEFEATURE/SPECIFICATION(ECLIPSE 10- K102011)	DEVICE WITH CHANGEECLIPSE 12
SupportedExternal Beams& Accessories	• TrueBeam support	• TrueBeam support
Graphical UserInterface	• Nexus Phase 0 - Homescreen integration andnavigation not present	• Nexus Phase 0- Home screen integrationand navigation
ImageSegmentation	• Automatic on-demandand pre-processing toolsfor multipleorgans/structures	• No Automatic on-demand and pre-processing tools for multipleorgans/structures(SmartAdapt) toolset utilizing changed CT-MR and MR-MR deformable registration
DoseCalculation	• Photon calculation○ RapidArc:intermediatedose calculation○ RapidArc: Varianlinac and support○ FFF support forTrueBeam	• Photon calculation○ RapidArc: enhancements inintermediate dose calculation○ IMRT: intermediate dosecalculation○ RapidArc Varian linac, and ElektaVMAT support○ FFF: Support for C3 andTrueBeam• Dose-Volume Histogram (DVH) Estimation
	• Proton calculation○ Modulatedscanning (spotscanning)technique○ Spot editor	• Proton calculation○ Modulated scanning technique(spot and line scanning), supportblock and MLC○ Range uncertainty feature○ Spot editor user interfaceimprovements○ Dosimetrically equivalenttreatment units (for differentgantries)○ Block drill bit corrections formilling machines
	• Brachytherapy calculation○ AcurosBV dosecalculationalgorithm○ AcurosBVcalculates dose totransport mediabut reports it inwater	• Brachytherapy calculation○ AcurosBV dose calculationalgorithm in 64 bit environment○ AcurosBV calculates does totransport media○ Nexus phase 0 support
FEATURE AND/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	CLEARED DEVICEFEATURE/SPECIFICATION(ECLIPSE 10- K102011)	DEVICE WITH CHANGEECLIPSE 12
	64 bit External BeamPlanning, BrachyVisionand Proton, PRO andAcurosXB algorithms Fluence calculation byLMC algorithm	64 bit External Beam Planning,BrachyVision and Proton, PRO, AcurosXBAcurosBV and BAO & DVO algorithms andDVH Estimation. Unified fluence calculation in Eclipse &DCF by the final 3D dose calculationalgorithm
Import/ExportInterfaces	Film Scanner import	No Film Scanner import Eclipse Scripting API (ESAPI) read onlyaccess
Infrastructure	Sybase Server	SQL Server migration Zero Clinical Downtime: Faster DBupgrades Zero Clinical Downtime: Remotedeployment of the clients Nexus Phase 0 RT Prescription integration Plan validation and status changeservice Dosimetrically Equivalentmachine change service Approval modifications

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and the commend of the comments of the country

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K131891
Page 4 of 4

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.