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 is a 510(k) summary for the Varian Eclipse Treatment Planning System, a software device used for radiation therapy planning. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:
"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. 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."

This statement confirms that verification and validation were done and that the product conformed to user needs and intended uses, implying that acceptance criteria were met. However, it does not provide the specific metrics or details of these acceptance criteria, nor the methodology of the study.

Therefore, I cannot provide the requested information from the given text. The document does not include:

A table of acceptance criteria and the reported device performance: This detailed information is not present. The document only states that the product "conformed to the defined user needs and intended uses."
Sample size used for the test set and the data provenance: The document mentions "verification and validation" and "regression testing" but does not provide sample sizes or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study seems irrelevant for a treatment planning system comparing features against a predicate device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The evaluation performed is described as "Verification and Validation" and ensuring "conformed to the defined user needs and intended uses," which implies human judgment in the overall process of using the software. It does not detail a standalone algorithm performance test.
The type of ground truth used: Not specified. It generally refers to conformance to "defined user needs and intended uses" and the absence of "discrepancy reports."
The sample size for the training set: Not applicable for this type of software submission as it's not an AI/ML device in the modern sense of requiring extensive training data. It's a deterministic treatment planning system.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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K133247
Page 1 of 6

· PREMARKET NOTIFICATION

510(k) Summary

7 2014

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-Director Regulatory Affairs Phone: 650/424.6230 Fax:650/842.5040 E-mail: submissions.support@varian.com Date: 30d October 2013

Eclipse Treatment Planning System

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

Eclipse TPS, Eclipse, Treatment Planning System.

Eclipse Treatment Planning System 12 (K131891)

Proprietary Name:

Classification Name:

Common/Usual Name:

Predicate Devices:

Device Description:

Indications for Use:

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Changes in Technological Characteristics:

The significant changes in this device are those associated with the change to the Proton optimizer, modifications to the Proton Dose Calculation algorithm, Proton Layer by Layer MLC support and the Improved second source modeling in AAA and AXB.

Device Comparison Table ·

(Changed Features are in bold).

FEATURE AND/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	PREDICATE DEVICE	DEVICE WITH CHANGE
	K131891	ECLIPSE 13
	ECLIPSE 12
General usage	External beam PHOTON planning External beam PHOTON inverse planning External beam ELECTRON planning External beam PROTON planning External beam OCULAR PROTON planning Internal BRACHYTHERAPY planning Stereotactic Frame Localization	External beam PHOTON planning External beam PHOTON inverse planning External beam ELECTRON planning External beam PROTON planning External beam OCULAR PROTON planning Internal BRACHYTHERAPY planning Stereotactic Frame Localization
Supported ExternalBeams &Accessories	Photon beams Electron beams Proton beams Coplanar fields Non-coplanar fields Multi-leaf Collimators Asymmetric collimators Stereotactic Cone collimators Arc fields Poured Blocks Compensators Physical wedges Dynamic wedges Flattening filter free support (FFF) Rotating treatment couch TrueBeam 1.5 support TrueBeam 1.6 support.	Photon beams Electron beams Proton beams Coplanar fields Non-coplanar fields Multi-leaf Collimators Asymmetric collimators Stereotactic Cone collimators Arc fields Poured Blocks Compensators Physical wedges Dynamic wedges Flattening filter free support (FFF) Rotating treatment couch TrueBeam 1.5 support TrueBeam 1.6 and 2.0 support. Support forLE imaging (2.5X for imaging only) andsupport for new portal imager.
SupportedBrachytherapySources &Accessories	Plan for high dose rate afterloader Manual low dose rate brachytherapy: seeds,line sources, wire Applicator library Needle templates	Plan for high dose rate afterloader Manual low dose rate brachytherapy: seeds,line sources, wire Applicator library Needle templates
Graphical UserInterface	Multiple-instance application Multiple-workspace layout Graphical display/editing of field parameters Beam's-Eye-View display 3D patient image display Model for human Eye SRS Localization application SRS Planning application Biological Optimization application Biological Evaluation application 3D Conformal Optimization application Nexus Phase 0 - Home screen integration andnavigation	Multiple-instance application Multiple-workspace layout Graphical display/editing of field parameters Beam's-Eye-View display 3D patient image display Model for human Eye SRS Localization application SRS Planning application Biological Optimization application Biological Evaluation application 3D Conformal Optimization application Nexus Phase 0 - Home screen integration andnavigation Limited RT Prescription information availablein Eclipse
Image Processing	Orthogonal image displays (3) Oblique image display Edge enhancement filters Image smoothing filters CT/MR/PET Image Registration	Orthogonal image displays (3) Oblique image display Edge enhancement filters Image smoothing filters CT/MR/PET Image Registration
FEATURE AND/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	PREDICATE DEVICE	DEVICE WITH CHANGE
	K131891
	ECLIPSE 12	ECLIPSE 13
ImageSegmentation	Image blending utility 4D image display (registration of time series of3D images) Digitally reconstructed radiographs Enclosed Volume measurement Stereotactic Frame Coordinate transformation Geometrical shapes Manual editing and manipulation tools Automatic/semi-automatic tools Automatic/semi-automatic on-demand andpost-processing tools for individualorgans/structures No Automatic on-demand and pre-processingtools for multiple organs/structures (SmartAdapt) toolset utilizing changed CT-MRand MR-MR deformable registration 3D Automargin Logical operators	Image blending utility 4D image display (registration of time series of3D images) Digitally reconstructed radiographs Enclosed Volume measurement Stereotactic Frame Coordinate transformation Geometrical shapes Manual editing and manipulation tools Automatic/semi-automatic tools Automatic/semi-automatic on-demand andpost-processing tools for individualorgans/structures No Automatic on-demand and pre-processingtools for multiple organs/structures (SmartAdapt) toolset utilizing changed CT-MRand MR-MR deformable registration Separate Selection Workspace and enhancedContouring 3D Automargin Logical operators
Dose Calculation	Distributed Calculation Framework Photon calculation Energy Range: 1 MV - 50 MV CT-based volumetric calculation Non-CT based IRREG calculation Convolution method Combined electron/photon scatter Directional heterogeneitycorrection Treatment head modeling Photon Monitor Unit calculation Compensator monitor unitcalculation Beam Angle Optimization (GEOS) Leaf Motion Sequencing Dose Dynamic Arc planning Cone Dose Calculation Biological optimization 3D Conformal Optimization IMRT optimization AcurosXB dose calculationalgorithm RapidArc: enhancements inintermediate dose calculation IMRT: intermediate dosecalculation RapidArc Varian linac, and ElektaVMAT support FFF: Support for C3 and TrueBeam Dosimetrically equivalent machines	Distributed Calculation Framework Photon calculation Energy Range: 1 MV - 50 MV CT-based volumetric calculation Non-CT based IRREG calculation Convolution method Combined electron/photon scatter Directional heterogeneitycorrection Treatment head modeling Photon Monitor Unit calculation Compensator monitor unitcalculation Beam Angle Optimization (GEOS) Leaf Motion Sequencing Dose Dynamic Arc planning Cone Dose Calculation Biological optimization 3D Conformal Optimization IMRT optimization AcurosXB dose calculationalgorithm RapidArc: enhancements inintermediate dose calculation IMRT: intermediate dosecalculation RapidArc Varian linac, and ElektaVMAT support FFF: Support for C3 and TrueBeam Dosimetrically equivalent machines Plan uncertainty for photon plans Isocenter handling improvements Addition of Point Dosefunctionality into AAA dosecalculation algorithm Improved second source modelingin AAA and AXB
	SmartIMRTDose-Volume Histogram (DVH)Estimation*
	Electron calculation	Electron calculation
FEATURE AND/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	PREDICATE DEVICE	DEVICE WITH CHANGE
	K131891ECLIPSE 12	ECLIPSE 13
	Gaussian Pencil Beam Model Electron Monte Carlo algorithm Electron Monitor Unit calculation Dosimetrically equivalent machines Proton calculation Energy Range: 50 MeV - 300 MeV Single scattering technique, support block and MLC Double scattering technique, support block and MLC Uniform scanning technique, support block and MLC Modulated scanning technique (spot and line scanning), support block and MLC Single scattering technique Optimization for modulated scanning Monitor unit calculation for modulated scanning Range uncertainty feature Spot editor user interface improvements Dosimetrically equivalent treatment units (for different gantries) Block drill bit corrections for milling machines	Gaussian Pencil Beam Model Electron Monte Carlo algorithm Electron Monitor Unit calculation Dosimetrically equivalent machines Proton calculation Energy Range: 50 MeV - 300 MeV Single scattering technique, support block and MLC Double scattering technique, support block and MLC Uniform scanning technique, support block and MLC Modulated scanning technique (spot and line scanning), support block and MLC Single scattering technique Optimization for modulated scanning Monitor unit calculation for modulated scanning Range uncertainty feature Spot editor user interface improvements Dosimetrically equivalent treatment units (for different gantries) Support for Sumitomo tx machine with Layer-by-Layer MLC Non-linear universal proton optimizer PCS enhancements Block drill bit corrections for milling machines
	Brachytherapy calculation AAPM TG 43 compliant Point Dose calculation Optimization to point dose constraints Geometric optimization AcurosBV dose calculation algorithm in 64 bit environment AcurosBV calculates does to transport media Nexus phase 0 support **	Brachytherapy calculation AAPM TG 43 compliant Point Dose calculation Optimization to point dose constraints Geometric optimization AcurosBV dose calculation algorithm in 64 bit environment AcurosBV calculates does to transport media and reports dose to transport media Addition of TG186 source model and standard applicator for AcurosBV Nexus phase 0 support Source model approval Enhanced Normal Tissue and Source Fitting Simple contouring tools in Planning workspace Nominal Time Constraints in Volumetric Optimizer New version of AcurosBV algorithm Dose tracking support Ability to calculate AcurosBV on non-CT image
FEATURE AND/ORSPECIFICATION OFNEW/MODIFIEDDEVICE	PREDICATE DEVICE	DEVICE WITH CHANGE
	K131891	ECLIPSE 13
	ECLIPSE 12
	Eclipse Algorithm Application ProgrammingInterface (EAAPI) 64 bit External Beam Planning, BrachyVisionand Proton, PRO, AcurosXB, AcurosBV andBAO & DVO algorithms Unified fluence calculation in Eclipse & DCF bythe final 3D dose calculation algorithm	Eclipse Algorithm Application ProgrammingInterface (EAAPI) 64 bit External Beam Planning, BrachyVisionand Proton, PRO, AcurosXB, AcurosBV andBAO & DVO algorithms Unified fluence calculation in Eclipse & DCF bythe final 3D dose calculation algorithm
Dose evaluation	Dose color wash 2D, 3D Isodose levels 2D, 3D Isodose Surface 3D Reference point dose summary Dose Volume Histogram plot Plan summing tool Plan comparison tools Evaluation using biological models	Dose color wash 2D, 3D Isodose levels 2D, 3D Isodose Surface 3D Reference point dose summary Dose Volume Histogram plot Plan summing tool Plan comparison tools Evaluation using biological models
Plan Output -Hardcopy	Graphics window screen dump Patient administration data Plan parameters Geometrical displays of plan data Dose distribution DVH plot BEV display Patient orientation User Configurable hardcopy layouts	Graphics window screen dump Patient administration data Plan parameters Geometrical displays of plan data Dose distribution DVH plot BEV display Patient orientation User Configurable hardcopy layouts
Import/ExportInterfaces	ARIA RadOnc integration DICOM RT Other image formats Electromagnetic Digitizer import No Film Scanner import Eclipse Scripting API (ESAPI) read only access Export field coordinates to Laser System	ARIA RadOnc integration DICOM RT Other image formats Electromagnetic Digitizer import No Film Scanner import Eclipse Scripting API (ESAPI) read only accessincluding brachytherapy plans, write accessin non-clinical system Export field coordinates to Laser System
Infrastructure	SQL Server migration Zero Clinical Downtime: Faster DB upgrades Zero Clinical Downtime: Remote deploymentof the clients Nexus Phase O RT Prescription integration Plan validation and status changeservice Dosimetrically Equivalent machinechange service Approval modifications	SQL Server migration Zero Clinical Downtime: Faster DB upgrades Zero Clinical Downtime: Remote deploymentof the clients Nexus Phase O RT Prescription integration Plan validation and status changeservice Dosimetrically Equivalent machinechange service Approval modifications Unicode support Electronic acceptance of Customer ApprovalTests MD5 checksums in dose calculation related

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・

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*For business reasons this feature is not being commercialized at this time.

** Nexus is a project involving the Aria product. Aria is not part of this submission

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K133247
Page 6 of 6

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 to be safe 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 changes to the Proton Optimizer, modifications to the Proton Dose Calculation algorithm, introduction of Proton Layer by Layer MLC support, and the improved second source modeling in AAA and AXB. Other changes are related to dose calculations and scripting for Brachytherapy, image segmentation, import and export interfaces and infrastructure.

These changes are all considered by Varian to be enhancements of 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Silver Spring. MD 20993-0002

February 7, 2014

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

Re: K133247

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: October 3, 2013 Received: November 4, 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 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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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/Resourcesfor You/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/Safetv/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

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): K133247

Device Name: Eclipse Treatment Planning System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

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.