(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not contain any language suggesting the use of AI or ML in the device description or performance studies.
No
The device is a treatment planning system used by medical professionals to design and simulate radiation therapy, not a device that directly or indirectly treats a disease.
No
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 "Eclipse TPS is a computer-based software device". While it is used in conjunction with hardware (radiotherapy machines), the device itself, as described in the 510(k) summary, is the software component.
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 the device is used for planning radiotherapy treatments for malignant or benign diseases. This involves designing and simulating radiation therapy, which is a treatment modality applied directly to the patient.
- Device Description: The description reinforces that it's a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Eclipse TPS does not perform any such analysis of biological specimens.
The device is a medical device used in the planning and delivery of radiation therapy, but it does not fit the definition of an In Vitro Diagnostic device.
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 (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 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.
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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2017
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K170969
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: June 7, 2017 Received: June 8, 2017
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
1
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.
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/ResourcesforYou/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,
Michael D. O'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)
K170969
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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, CA 94304
Contact Name: Peter J. Coronado-Director Regulatory Affairs
Phone: 650/424.6230
Fax: 650/646.9200
E-mail: submissions.support@varian.com |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 13.7 (K152393). |
| 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:
-
- Support for treatment planning for Varian RDS radiotherapy treatment units.
-
- Scripting is enhanced to include Script Approval and Eclipse Automation.
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
| | PREDICATE DEVICE
FEATURE/SPECIFICATION
510(K) ID# K152393
ECLIPSE TPS v13.7 | MODIFIED DEVICE
FEATURE/SPECIFICATION
ECLIPSE TPS v15.1.1 |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 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) | No *) | No *) |
| Internal BRACHYTHERAPY planning | Yes | Yes |
| Stereotactic Frame Localization | Yes | Yes |
| Treatment Planning for Varian RDS | No | 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 |
| Elekta Versa HD (FFF) | Yes | Yes |
| Rotating treatment couch | Yes | Yes |
| Non-rotating RDS couch | No | Yes |
| Elekta Agility MLC 160 | Yes | Yes |
| Varian SX1 MLC | No | Yes |
| 4. Supported Brachytherapy Sources &
Accessories | | |
| Plan for high dose rate afterloader | Yes | Yes |
| | PREDICATE DEVICE
FEATURE/ SPECIFICATION
510(K) ID# K152393 | MODIFIED DEVICE
FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| 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 | No *) | 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 | Yes | Yes |
| 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 | | |
| | PREDICATE DEVICE
FEATURE/ SPECIFICATION
510(k) ID# K152393 | MODIFIED DEVICE
FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| 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 |
| - AAA | Yes | Yes |
| - Range Uncertainty feature for photons | Yes | Yes |
| - Siemens mArc | Yes | Yes |
| - Siemens FFF (unflattened beam) | Yes | Yes |
| - Elekta Agility MLC 160 | Yes | Yes |
| - RaySearch PlanConverter | Yes | Yes |
| - Varian SX1 MLC | No | Yes |
| - FTDC Imaging dose calculation for RDS machine | 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 v2 | Yes
(including Siemens, Elekta) | Yes
(including Siemens, Elekta) |
| - Electron Monitor Unit calculation | Yes | Yes |
| - Portal Dose Image Prediction | 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 |
| | PREDICATE DEVICE
FEATURE/ SPECIFICATION
510(k) ID# K152393 | MODIFIED DEVICE
FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| - 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 | Yes | Yes |
| - AcurosPT Dose Calculation Algorithm | Yes | 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 |
| | (with support for
report the dose to medium) | (with support for
report the dose to medium) |
| - Intermediate dose capability for AcurosBV algorithm | Yes | Yes |
| - Solid applicator model support | Yes | 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 |
| | PREDICATE DEVICE
FEATURE/ SPECIFICATION
510(k) ID# K152393 | MODIFIED DEVICE
FEATURE/ SPECIFICATION |
| | ECLIPSE TPS v13.7 | ECLIPSE TPS v15.1.1 |
| 11.
Import/Export Interfaces | | |
| 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
(includes also BrachyVision
and Proton) | yes
(includes also BrachyVision
and Proton) | yes
(includes also BrachyVision
and Proton) |
| Eclipse Scripting API (ESAPI) write access
(in research database, only,
with additional proton
planning support) | Yes
(in research database, only,
with additional proton
planning support) | Yes
(in research database, only,
with additional proton
planning support) |
| Eclipse Automation | No | Yes |
| Export field coordinates to Laser System | export | export |
| Basic RT Prescription information available | Yes | Yes |
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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 15.1.1 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 support for treatment planning for Varian RDS radiotherapy treatment units and Eclipse Automation.
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.