(83 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning software functionalities.
No
The device is a treatment planning system (software) used by medical professionals to design and simulate radiation therapy treatments, not to directly provide therapeutic treatment to a patient.
No
The device is described as a "Treatment Planning System" used for designing and simulating radiation therapy treatments, not for diagnosing diseases. Its purpose is to plan the treatment once a diagnosis has already been made.
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 510(k) summary focuses solely on the software component and its validation.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Eclipse TPS Function: The description clearly states that Eclipse TPS is a software device used to plan radiotherapy treatments. It takes imaging data (CT/MR/PET) and helps trained medical professionals design and simulate radiation therapy.
- No Specimen Examination: There is no mention of the device examining any biological specimens from the human body. Its function is based on processing medical images and calculating radiation doses and treatment plans.
Therefore, the Eclipse TPS falls under the category of a medical device used for treatment planning, not 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
Not Found
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of three human profiles facing to the right, forming a trefoil shape. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K141283
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: April 30, 2014 Received: May 16, 2014
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 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" (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 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
2
Indications for Use
510(k) Number (if known) K141283
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D'Hara
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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 CA94304 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado-Director Regulatory Affairs
Phone: 650/424.6230
Fax: 650/646.9200
E-mail: submissions.support@varian.com
Date: 30th April 2014 |
| 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 (K133247)
Eclipse Treatment Planning System 12 (K131891) |
| 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 changes associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines.
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
| | ECLIPSE TPS V12.0
(510(k) ID # K131891) | ECLIPSE TPS V13.0
(510(k) ID #K133247) | ECLIPSE TPS V13.5 |
|------------------------------------------------|--------------------------------------------|-------------------------------------------|-------------------|
| 2. General Usage | | | |
| External beam PHOTON
planning | yes | yes | yes |
| External beam PHOTON
inverse planning | yes | yes | yes |
| External beam ELECTRON
planning | yes | yes | yes |
| External beam PROTON
planning | yes | yes | yes |
| External beam OCULAR
PROTON planning (EOPP) | no | yes | yes |
| Internal BRACHYTHERAPY
planning | yes | yes | yes |
| Stereotactic Frame Localization | yes | yes | yes |
| 3. Supported External Beams
& Accessories | | | |
| Photon beams | yes | yes | yes |
| Electron beams | yes | yes | yes |
| Proton beams | yes | yes | yes |
| Coplanar fields | yes | yes | yes |
| Non-coplanar fields | yes | yes | yes |
| Multi-leaf Collimators | yes | yes | yes |
| Asymmetric collimators | yes | yes | yes |
| Stereotactic Cone collimators | yes | yes | yes |
| Arc fields | yes | yes | yes |
| Poured Blocks | yes | yes | yes |
| Compensators | yes | yes | yes |
| Physical wedges | yes | yes | yes |
5
| Dynamic wedges | yes | yes | yes |
|---|---|---|---|
| Flattening filter free support | |||
| (FFF) | yes | yes | yes |
| Rotating treatment couch | yes | yes | yes |
| 4. Supported Brachytherapy | |||
| Sources & Accessories | |||
| Plan for high dose rate | |||
| afterloader | yes | yes | yes |
| Manual low dose rate | |||
| brachytherapy: seeds, line | |||
| sources, wire | yes | yes | yes |
| Applicator library | yes | yes | yes |
| Needle templates | yes | yes | yes |
| Seed templates | no | no | yes |
| 5. Graphical User Interface | |||
| Multiple-instance application | yes | yes | yes |
| Multiple-workspace layout | yes | yes | yes |
| Graphical display/editing of | |||
| field parameters | yes | yes | yes |
| Beam's-Eye-View display | yes | yes | yes |
| 3D patient image display | yes | yes | yes |
| Model for human Eye | yes | yes | yes |
| SRS Localization application | yes | yes | yes |
| SRS Planning application | yes | yes | yes |
| Biological Optimization | |||
| application | yes | yes | yes |
| Biological Evaluation | |||
| application | yes | yes | yes |
| 3D Conformal Optimization | |||
| application | yes | yes | yes |
| 6. Image Processing | |||
| Orthogonal image displays (3) | yes | yes | yes |
| Oblique image display | yes | yes | yes |
| Edge enhancement filters | yes | yes | yes |
| Image smoothing filters | yes | yes | yes |
| CT/MR/PET Image Registration | yes | yes | yes |
| Image blending utility | yes | yes | yes |
| 4D image display (registration | |||
| of time series of 3D images) | yes | yes | yes |
| Digitally reconstructed | |||
| radiographs | yes | yes | yes |
6
| Enclosed Volume
| measurement | yes | yes | yes |
|---|---|---|---|
| Stereotactic Frame Coordinate | |||
| transformation | yes | yes | yes |
| 7. Image Segmentation | |||
| Geometrical shapes | yes | yes | yes |
| Manual editing and | |||
| manipulation tools | yes | yes | yes |
| Automatic /semi-automatic | |||
| tools | yes | yes | yes |
| Automatic/semi-automatic on- | |||
| demand and post-processing | |||
| tools for individual | |||
| organs/structures | yes | yes | yes |
| 3D Automargin | yes | yes | yes |
| Logical operators | yes | yes | yes |
| Enhanced 2D and 3D | |||
| contouring tools | no | yes | yes |
| Enhanced 4D functionality, | |||
| including structure propagation | |||
| and display of respiratory | |||
| amplitude distribution | no | yes | yes |
| 8. Dose Calculation | |||
| Distributed Calculation | |||
| Framework | yes | yes | yes |
| Photon calculation | yes | yes | yes |
| - Energy Range | 1 MV – 50 MV | 1 MV – 50 MV | 1 MV – 50 MV |
| - CT-based volumetric | |||
| calculation | yes | yes | yes |
| - Non-CT based IRREG | |||
| calculation | yes | yes | yes |
| - Convolution method | yes | yes | yes |
| - Combined electron/photon | |||
| scatter | yes | yes | yes |
| - Directional heterogeneity | |||
| correction | yes | yes | yes |
| - Treatment head modelling | yes | yes | yes |
| - Photon Monitor Unit | |||
| calculation | yes | yes | yes |
| - Compensator monitor unit | |||
| calculation | yes | yes | yes |
| - Beam Angle Optimization | |||
| (GEOS) | yes | yes | yes |
7
| - Dose Dynamic Arc planning | yes | yes | yes |
|---|---|---|---|
| - Cone Dose Calculation | yes | yes | yes |
| - Biological optimization | yes | yes | yes |
| - 3D Conformal Optimization | yes | yes | yes |
| - IMRT optimization | yes | yes | yes |
| - AcurosXB dose calculation | |||
| algorithm | yes | yes | yes |
| - Range Uncertainty feature | |||
| for photons | no | yes | yes |
| - Siemens mArc | no | no | yes |
| Electron calculation | yes | yes | yes |
| - Energy Range | 1 MeV - 50 MeV | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| - Gaussian Pencil Beam Model | yes | yes | yes |
| - Electron Monte Carlo | |||
| algorithm | yes | yes | yes |
| - Electron Monitor Unit | |||
| calculation | yes | yes | yes |
| Proton calculation | yes | yes | yes |
| - Energy Range | 50 MeV - 300 MeV | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| - Single scattering technique | yes | yes | yes |
| - Double scattering technique | yes | yes | yes |
| - Uniform scanning technique | yes | yes | yes |
| - Modulated scanning | |||
| technique | yes | yes | yes |
| - Optimization for modulated | |||
| scanning | yes | yes | |
| (new implementation | |||
| for | |||
| Proton Optimizer) | yes | ||
| - Monitor unit calculation for | |||
| modulated scanning | yes | yes | yes |
| - Range uncertainty feature | |||
| for Protons | yes | yes | yes |
| Brachytherapy calculation | yes | yes | yes |
| - AAPM TG 43 compliant | yes | yes | yes |
| - Point Dose calculation | yes | yes | yes |
| - Optimization to point dose | |||
| constraints | yes | yes | yes |
| - Geometric optimization | yes | yes | yes |
| - AcurosBV dose calculation | |||
| algorithm | yes | yes | |
| (with support for | |||
| report the dose to | |||
| medium) | yes |
8
| Eclipse Algorithm Application
| Programming Interface (EAAPI) | yes | yes | yes |
|---|---|---|---|
| RapidPlan - Dose Volume | |||
| Histogram (DVH) Estimation | yes | no | Yes |
| (extended Dose | |||
| Volume Histogram | |||
| (DVH) Estimation) | |||
| 9. Dose evaluation | |||
| Dose color wash | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D | 3D |
| Reference point dose summary | yes | yes | yes |
| Dose Volume Histogram plot | yes | yes | yes |
| Plan summing tool | yes | yes | yes |
| Plan comparison tools | yes | yes | yes |
| Evaluation using biological | |||
| models | yes | yes | yes |
| 10. Plan Output - Hardcopy | |||
| Graphics window screen dump | yes | yes | yes |
| Patient administration data | yes | yes | yes |
| Plan parameters | yes | yes | yes |
| Geometrical displays of plan | |||
| data | yes | yes | yes |
| Dose distribution | yes | yes | yes |
| DVH plot | yes | yes | yes |
| BEV display | yes | yes | yes |
| Patient orientation | yes | yes | yes |
| User Configurable hardcopy | |||
| layouts | yes | yes | yes |
| Import/Export |
Interfaces | | | |
| ARIA RadOnc integration | yes | yes | yes |
| DICOM RT | yes | yes | yes |
| Other image formats | yes | yes | yes |
| Electromagnetic Digitizer | import | import | import |
| Eclipse Scripting API (ESAPI)
read only access | yes | yes
(includes also
BrachyVision) | yes
(includes also
BrachyVision) |
| Eclipse Scripting API (ESAPI)
write access | no | yes
(in research database,
only) | yes
(in research database,
only) |
9
| Export field coordinates to
| Laser System | yes | export | export |
|---|---|---|---|
| Basic RT Prescription | |||
| information available | no | yes | yes |
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 13.5 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. Of these, the significant changes compared with the predicate are associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines. Other changes are the addition of new BrachyVision features.
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.