(108 days)
Not Found
No
The document does not mention AI, DNN, or ML, nor does it describe any features or performance metrics typically associated with AI/ML algorithms.
No
The device is a treatment planning system (software) used by medical professionals, not a device that directly delivers therapy to a patient.
No
The device is described as a "Treatment Planning System" used for planning radiotherapy treatments. It does not perform diagnosis of diseases.
Yes
The device description explicitly states it is a "computer-based software device" and the entire summary focuses on software functionalities and validation. There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Eclipse Treatment Planning System is described as a software device used by medical professionals to plan radiotherapy treatments. It uses imaging data (CT/MR/PET) to design and simulate radiation therapy.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing biological samples from a patient. Its function is focused on using imaging data to create a treatment plan.
Therefore, the core function of the Eclipse Treatment Planning System falls outside the scope of in vitro diagnostics. It is a medical device used for treatment planning, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MR/PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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.
Proprietary Name:
Classification Name:
Common/Usual Name:
Predicate Devices:
Device Description:
Indications for Use:
1
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/OR
SPECIFICATION OF
NEW/MODIFIED
| DEVICE | 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 External | ||
| Beams & | ||
| 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 for |
| LE imaging (2.5X for imaging only) and | ||
| support for new portal imager. | ||
| Supported | ||
| Brachytherapy | ||
| Sources & | ||
| 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 User | ||
| Interface | 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 and | |
| navigation | 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 and | |
| navigation Limited RT Prescription information available | ||
| in 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/OR | ||
| SPECIFICATION OF | ||
| NEW/MODIFIED | ||
| DEVICE | PREDICATE DEVICE | DEVICE WITH CHANGE |
| K131891 | ||
| ECLIPSE 12 | ECLIPSE 13 | |
| Image | ||
| Segmentation | Image blending utility 4D image display (registration of time series of | |
| 3D 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 and | ||
| post-processing tools for individual | ||
| organs/structures No Automatic on-demand and pre-processing | ||
| tools for multiple organs/structures (SmartAdapt) toolset utilizing changed CT-MR | ||
| and MR-MR deformable registration 3D Automargin Logical operators | Image blending utility 4D image display (registration of time series of | |
| 3D 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 and | ||
| post-processing tools for individual | ||
| organs/structures No Automatic on-demand and pre-processing | ||
| tools for multiple organs/structures (SmartAdapt) toolset utilizing changed CT-MR | ||
| and MR-MR deformable registration Separate Selection Workspace and enhanced | ||
| Contouring 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 heterogeneity | |
| correction Treatment head modeling Photon Monitor Unit calculation Compensator monitor unit | ||
| calculation Beam Angle Optimization (GEOS) Leaf Motion Sequencing Dose Dynamic Arc planning Cone Dose Calculation Biological optimization 3D Conformal Optimization IMRT optimization AcurosXB dose calculation | ||
| algorithm RapidArc: enhancements in | ||
| intermediate dose calculation IMRT: intermediate dose | ||
| calculation RapidArc Varian linac, and Elekta | ||
| VMAT 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 heterogeneity | |
| correction Treatment head modeling Photon Monitor Unit calculation Compensator monitor unit | ||
| calculation Beam Angle Optimization (GEOS) Leaf Motion Sequencing Dose Dynamic Arc planning Cone Dose Calculation Biological optimization 3D Conformal Optimization IMRT optimization AcurosXB dose calculation | ||
| algorithm RapidArc: enhancements in | ||
| intermediate dose calculation IMRT: intermediate dose | ||
| calculation RapidArc Varian linac, and Elekta | ||
| VMAT support FFF: Support for C3 and TrueBeam Dosimetrically equivalent machines Plan uncertainty for photon plans Isocenter handling improvements Addition of Point Dose | ||
| functionality into AAA dose | ||
| calculation algorithm Improved second source modeling | ||
| in AAA and AXB | ||
| SmartIMRTDose-Volume Histogram (DVH) | ||
| Estimation* | ||
| Electron calculation | Electron calculation | |
| FEATURE AND/OR | ||
| SPECIFICATION OF | ||
| NEW/MODIFIED | ||
| DEVICE | PREDICATE DEVICE | DEVICE WITH CHANGE |
| K131891 |
ECLIPSE 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/OR
SPECIFICATION OF
NEW/MODIFIED
DEVICE | PREDICATE DEVICE | DEVICE WITH CHANGE |
| | K131891 | ECLIPSE 13 |
| | ECLIPSE 12 | |
| | Eclipse Algorithm Application Programming
Interface (EAAPI) 64 bit External Beam Planning, BrachyVision
and Proton, PRO, AcurosXB, AcurosBV and
BAO & DVO algorithms Unified fluence calculation in Eclipse & DCF by
the final 3D dose calculation algorithm | Eclipse Algorithm Application Programming
Interface (EAAPI) 64 bit External Beam Planning, BrachyVision
and Proton, PRO, AcurosXB, AcurosBV and
BAO & DVO algorithms Unified fluence calculation in Eclipse & DCF by
the 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/Export
Interfaces | 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 access
including brachytherapy plans, write access
in non-clinical system Export field coordinates to Laser System |
| Infrastructure | SQL Server migration Zero Clinical Downtime: Faster DB upgrades Zero Clinical Downtime: Remote deployment
of the clients Nexus Phase O RT Prescription integration Plan validation and status change
service Dosimetrically Equivalent machine
change service Approval modifications | SQL Server migration Zero Clinical Downtime: Faster DB upgrades Zero Clinical Downtime: Remote deployment
of the clients Nexus Phase O RT Prescription integration Plan validation and status change
service Dosimetrically Equivalent machine
change service Approval modifications Unicode support Electronic acceptance of Customer Approval
Tests MD5 checksums in dose calculation related |
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3
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1
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:
4
*For business reasons this feature is not being commercialized at this time.
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.
·
** Nexus is a project involving the Aria product. Aria is not part of this submission
5
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.
6
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.
7
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
8
Indications for Use
510(k) Number (if known): K133247
Device Name: Eclipse Treatment Planning System
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 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
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