(28 days)
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 Eclipse Treatment Planning System is a software device used to plan radiotherapy treatments, not to deliver them. It provides tools for designing and simulating treatments for medical professionals.
No
The device is used for planning radiotherapy treatments, not for diagnosing diseases or conditions.
Yes
The device description explicitly states that Eclipse TPS is a "computer-based software device" and the entire summary focuses on software functionalities for treatment planning. There is 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Eclipse TPS Function: The description clearly states that Eclipse TPS is used for planning radiotherapy treatments. It takes imaging data (CT, MR, PET) and helps medical professionals design and simulate radiation therapy. It does not analyze biological specimens.
- Intended Use: The intended use is to "plan radiotherapy treatments," not to diagnose or monitor a disease through the analysis of biological samples.
Therefore, the Eclipse TPS falls under the category of a medical device used for treatment planning, not an IVD.
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
Yes
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)
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 15.5 to be safe 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 15.1.1 (K170969)
Reference Device(s)
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.
0
Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines beneath them that resemble waves or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K172163
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: July 17, 2017 Received: July 19, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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'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
2
Indications for Use
510(k) Number (if known)
K172163
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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3
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 15.1.1 (K170969). |
| 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. |
4
Changes in Technological Characteristics:
The significant changes compared with the predicate are associated with:
-
- Support for HyperArc Planning
- Support for Encompass Fixation Device (Encompass Structures for HyperArc) a.
-
- Trade-Off Exploration based on Multi-Criteria Optimization (MCO)
-
- GPU-calculation capability for select optimization and dose calculations
-
- Updated handling for Numerical Input Values (NIV)
-
- Inclusion of Smart Segmentation Knowledge Based Contouring (SS KBC) as an Eclipse module
- a. Updated Eclipse Image Registration and Segmentation IFU & Reference Guides
The complete list of Eclipse changes and their related requirements can be found in the document "Tracing Changed and New Features to System Requirements" in Section 18 of this submission; the indications for use and the intended use are the same in the subject device as for the predicate.
| | PREDICATE DEVICE
FEATURE/ SPECIFICATION
510(к) K170969
ECLIPSE TPS v15.1.1 | MODIFIED DEVICE
FEATURE/ SPECIFICATION
ECLIPSE TPS v15.5 |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Intended Use / Indications for Use | | |
| Statement of Intended Use and Indications for Use | Eclipse is intended to be used to plan radiotherapy
treatments for patients with malignant or benign
diseases. Eclipse 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. | Eclipse is intended to be used to plan radiotherapy
treatments for patients with malignant or benign
diseases. Eclipse 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. |
| 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 (Halcyon) | Yes | Yes |
| Automated Structure Delineation based on Expert
Case Library) | No, feature was part of
Smart Segmentation
Knowledge Based
Contouring (v3.6) | Yes, feature is included
as a part of Eclipse
Treatment Planning
System (v15.5) |
| 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 |
| Non-rotating RDS couch | Yes | Yes |
| Elekta 160 MLC | Yes | Yes |
| Varian SX1 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 | 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 |
| Expert Case Library) | No, feature was part of
Smart Segmentation
Knowledge Based
Contouring (v3.6) | Yes, feature is included
as a part of Eclipse
Treatment Planning
System (v15.5) |
| Multi-atlas Segmentation | | |
| Expert cases: Nasopharynx, Tonsil, Base of
Tongue, Hypopharynx, Larynx**) | | |
| Structure templates and dictionary with standardize
labels**) | | |
| Calypso segmentation **) | | |
| Segmentation of mandible ) | | |
| Semi-Automatic Segmentation of Lung Tumors)
(Lung Tumor Segmentation Tool) | | |
| Encompass Couch Model (Fixation Device) | No | 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 | No | No |
| - 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 (also GPU) |
| - AcurosXB dose calculation algorithm | Yes | Yes (also GPU) |
| - 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 | Yes | Yes |
| - FTDC Imaging dose calculation for RDS machine | Yes | Yes (also GPU) |
| Electron calculation | Yes | Yes |
| - Energy Range | 1 MeV – 50 MeV | 1 MeV – 50 MeV |
| - Gaussian Pencil Beam Model | Yes | No, obsoleted |
| - Electron Monte Carlo algorithm | No | No |
| - Electron Monte Carlo algorithm v2 | Yes
(incl. Siemens, Elekta) | Yes
(incl. 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 |
| - Uniform scanning technique | Yes | Yes |
| - Modulated scanning technique | 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
(w/ support for report the
dose to medium) | Yes
(w/ support for report the
dose to medium) |
| - Intermediate dose capability for AcurosBV algorithm | 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 |
| lsodose 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 |
| Evaluation using MCO (Multi-Criteria Optimization) | No | 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 |
| Patient orientation | Yes | Yes |
| 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 | Yes
(includes BrachyVision
and Proton) | Yes
(includes BrachyVision
and Proton) |
| Eclipse Scripting API (ESAPI) write access | Yes
(in research database,
only, with additional
proton planning support) | Yes
(in research database,
only, with additional
proton planning support) |
| Eclipse Automation | Yes | Yes |
| Export field coordinates to Laser System | Export | Export |
| Basic RT Prescription information available | Yes | Yes |
Device Comparison Table
5
6
7
8
9
*) 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.
**) Smart Segmentation - Knowledge Based Contouring (SS KBC) v2.2 was cleared under K141248. The corresponding features above were cleared previously as a part of that submission.
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 15.5 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. 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 Treatment Planning System is substantially equivalent to the predicate.