(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional software tools for treatment planning.
No
The device is a treatment planning system used to design and simulate radiation therapy treatments, not to deliver the treatment itself.
No
Explanation: The device is a treatment planning system used to design and simulate radiation therapy treatments, not to diagnose diseases.
Yes
The device description explicitly states it is a "computer-based software device" and the summary focuses on software verification and validation, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that Eclipse TPS is used to plan radiotherapy treatments for malignant or benign diseases. This involves designing and simulating radiation delivery to a patient's body.
- Device Description: The description reinforces this by stating it provides software tools for planning the treatment and is used by medical professionals to design and simulate radiation therapy treatments.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, tissue, or urine) outside the body to provide information for diagnosis, monitoring, or screening. Eclipse TPS does not perform any such analysis of biological specimens. Its function is focused on the delivery of treatment based on imaging data.
While it uses imaging modalities like CT, MR, and PET, these are used for anatomical information to guide the treatment planning process, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
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 Image Registration
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. Varian therefore considers Eclipse 13.7 to be safe and effective and to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Eclipse Treatment Planning System 13.5 (K141283)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Varian Medical Systems, Inc. % Mr. Peter Coronado Director Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K152393
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: August 21, 2015 Received: August 26, 2015
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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'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) K152393
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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-Director Regulatory Affairs
Phone: 650/424.6230
Fax: 650/646.9200
E-mail: submissions.support@varian.com
Date:21st August 2015 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Eclipse Treatment Planning System |
| Classification Name: | system,planning,radiation therapy treatment
21CFR892.5050, MUJ, Class II |
| Common/Usual Name: | Eclipse TPS, Eclipse, Treatment Planning System. |
| Predicate Devices: | Eclipse Treatment Planning System 13.5 (K141283). |
| 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. |
| 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. |
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Changes in Technological Characteristics:
The significant changes compared with the predicate are
-
- Addition of Acuros PT- a new Monte Carlo based dose calculation algorithm for Proton Planning
- Field Specific PTV- a new tool in proton planning for creating field-specific target volumes based on 2. field and patient geometries and proton planning uncertainties
-
- Acuros BV Intermediate dose calculation added to volumetric optimizer-Optimization
- a. takes into account image and applicator material heterogeneities.
- b. Includes Optimizer convergence detection.
The complete list of changes and their related requirements can be found in the document Tracing Changed/New Features to System Requirements in Section 18 of this submission.
Device Comparison Table
| | CLEARED DEVICE FEATURE/
SPECIFICATION | MODIFIED DEVICE FEATURE/
SPECIFICATION |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | |
| | 510(k) ID# K141283 | |
| | ECLIPSE TPS 13.5 NLS & MR1 | ECLIPSE TPS v13.7 |
| 2. General Usage | | |
| External beam PHOTON planning | Yes | Yes |
| External beam PHOTON inverse planning | Yes | Yes |
| External beam ELECTRON planning | Yes | Yes |
| External beam PROTON planning | Yes | Yes |
| External beam OCULAR PROTON planning
(EOPP) | Yes | No |
| Internal BRACHYTHERAPY planning | Yes | Yes |
| Stereotactic Frame Localization | Yes | Yes |
| 3. Supported External Beams &
Accessories | | |
| Photon beams | Yes | Yes |
| Electron beams | Yes | Yes |
| Proton beams | Yes | Yes |
| Coplanar fields | Yes | Yes |
| Non-coplanar fields | Yes | Yes |
| Multi-leaf Collimators | Yes | Yes |
| Asymmetric collimators | Yes | Yes |
| Stereotactic Cone collimators | Yes | Yes |
| Arc fields | Yes | Yes |
| Poured Blocks | Yes | Yes |
| Compensators | Yes | Yes |
| Physical wedges | Yes | Yes |
| Dynamic wedges | Yes | Yes |
| Flattening filter free support (FFF) | Yes | Yes |
| Rotating treatment couch | Yes | Yes |
| Elekta 160 MLC | Yes | Yes |
| 4. Supported Brachytherapy Sources &
Accessories | | |
| Plan for high dose rate afterloader | Yes | Yes |
| Manual low dose rate brachytherapy: seeds,
line sources, wire | Yes | Yes |
| Applicator library | Yes | Yes |
| Needle templates | Yes | Yes |
| Seed templates | Yes | Yes |
| 5. Graphical User Interface | | |
| Multiple-instance application | Yes | Yes |
| Multiple-workspace layout | Yes | Yes |
| Graphical display/editing of field parameters | Yes | Yes |
| Beam's-Eye-View display | Yes | Yes |
| 3D patient image display | Yes | Yes |
| Model for human Eye | Yes | No * |
| SRS Localization application | Yes | Yes |
| SRS Planning application | Yes | Yes |
| Biological Optimization application | Yes | Yes |
| Biological Evaluation application | Yes | Yes |
| 3D Conformal Optimization application | Yes | Yes |
| 6. Image Processing | | |
| Orthogonal image displays (3) | Yes | Yes |
| Oblique image display | Yes | Yes |
| Edge enhancement filters | Yes | Yes |
| Image smoothing filters | Yes | Yes |
| CT/MR/PET Image Registration | Yes | Yes |
| Image blending utility | Yes | Yes |
| 4D image display (registration of time series
of 3D images) | Yes | Yes |
| Digitally reconstructed radiographs | Yes | Yes |
| Enclosed Volume measurement | Yes | Yes |
| Stereotactic Frame Coordinate transformation | Yes | Yes |
| 7. Image Segmentation | | |
| Geometrical shapes | Yes | Yes |
| Manual editing and manipulation tools | Yes | Yes |
| Automatic /semi-automatic tools | Yes | Yes |
| Automatic/semi-automatic on-demand and
post-processing tools for individual
organs/structures | Yes | Yes |
| Automatic on-demand and pre-processing
tools for multiple organs/structures | No | No |
| 3D Automargin | Yes | Yes |
| Logical operators | Yes | Yes |
| Enhanced 2D and 3D contouring tools | Yes | Yes |
| Enhanced 4D functionality, including structure
propagation and display of respiratory
amplitude distribution | Yes | Yes |
| 8. Dose Calculation | | |
| Distributed Calculation Framework | Yes | Yes |
| Photon calculation | Yes | Yes |
| - Energy Range | 1 MV - 50 MV | 1 MV - 50 MV |
| - CT-based volumetric calculation | Yes | Yes |
| - Non-CT based IRREG calculation | Yes | Yes |
| - Convolution method | Yes | Yes |
| - Combined electron/photon scatter | Yes | Yes |
| - Directional heterogeneity correction | Yes | Yes |
| - Treatment head modelling | Yes | Yes |
| - Photon Monitor Unit calculation | Yes | Yes |
| - Compensator monitor unit calculation | Yes | Yes |
| - Beam Angle Optimization (GEOS) | Yes | Yes |
| - Leaf Motion Sequencing | Yes | Yes |
| - Dose Dynamic Arc planning | Yes | Yes |
| - Cone Dose Calculation | Yes | Yes |
| - Biological optimization | Yes | Yes |
| - 3D Conformal Optimization | Yes | Yes |
| - IMRT optimization | Yes | Yes |
| - AcurosXB dose calculation algorithm | Yes | Yes |
| - Range Uncertainty feature for photons | Yes | Yes |
| - Siemens mArc | Yes | Yes |
| - RaySearch PlanConverter | No | Yes |
| Electron calculation | Yes | Yes |
| - Energy Range | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| - Gaussian Pencil Beam Model | Yes | Yes |
| - Electron Monte Carlo algorithm | Yes | Yes (including Siemens,
Elekta) |
| - Electron Monitor Unit calculation | Yes | Yes |
| Proton calculation | Yes | Yes |
| - Energy Range | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| - Single scattering technique | Yes | Yes |
| - Double scattering technique | Yes | Yes |
| - Uniform scanning technique | Yes | Yes |
| - Modulated scanning technique | Yes | Yes |
| - Optimization for modulated scanning | yes | Yes |
| - Monitor unit calculation for modulated
scanning | Yes | Yes |
| - Range uncertainty feature for Protons | Yes | Yes |
| - Robust Proton Optimization | No | Yes |
| - AcurosPT Dose Calculation Algorithm | No | Yes |
| Brachytherapy calculation | Yes | Yes |
| - AAPM TG 43 compliant | Yes | Yes |
| - Point Dose calculation | Yes | Yes |
| - Optimization to point dose constraints | Yes | Yes |
| - Geometric optimization | Yes | Yes |
| - AcurosBV dose calculation algorithm | Yes | Yes |
| - Intermediate dose capability for AcurosBV
algorithm | No | Yes |
| Eclipse Algorithm Application Programming
Interface (EAAPI) | Yes | Yes |
| RapidPlan - Dose Volume Histogram (DVH)
Estimation | Yes
(extended Dose Volume
Histogram (DVH) Estimation) | Yes
(extended Dose Volume
Histogram (DVH) Estimation) |
| 9. Dose evaluation | | |
| Dose color wash | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D |
| Reference point dose summary | Yes | Yes |
| Dose Volume Histogram plot | Yes | Yes |
| Plan summing tool | Yes | Yes |
| Plan comparison tools | Yes | Yes |
| Evaluation using biological models | Yes | Yes |
| 10. Plan Output - Hardcopy | | |
| Graphics window screen dump | Yes | Yes |
| Patient administration data | Yes | Yes |
| Plan parameters | Yes | Yes |
| Geometrical displays of plan data | Yes | Yes |
| Dose distribution | Yes | Yes |
| DVH plot | Yes | Yes |
| BEV display | Yes | Yes |
| Patient orientation | Yes | Yes |
| User Configurable hardcopy layouts | Yes | Yes |
| ARIA RadOnc integration | Yes | Yes |
| DICOM RT | Yes | Yes |
| Other image formats | Yes | Yes |
| Electromagnetic Digitizer | import | Import |
| Film Scanner | no | no |
| Eclipse Scripting API (ESAPI) read only
access | yes
(includes also BrachyVision) | yes
(includes also BrachyVision
and Proton) |
| Eclipse Scripting API (ESAPI) write access | yes
(in research database, only) | Yes
(in research database, only,
with additional proton planning
support) |
| Export field coordinates to Laser System | export | export |
| Basic RT Prescription information available | Yes | Yes |
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7
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- A compatible feature has not been released and using the feature is blocked either by not including it in the distribution media for the indicated version(s) or by licensing.
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 13.7 to be safe and effective 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 associated with Acuros Proton Therapy, Field Specific PTV and Acuros BV intermediate dose calculation to volumetric optimizer.
These changes are all considered by Varian to be enhancements of the predicate. 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.