(88 days)
No
The summary describes a computer-based treatment planning system with standard image analysis, contouring, and dose calculation tools, but does not mention any AI or ML capabilities.
No.
The device is used for planning and reviewing radiation therapy treatments, not for directly administering therapy.
No
The device is used for treatment planning in radiation therapy, which is a therapeutic process. While it includes tools for diagnostic image analysis, contouring, and segmentation, its primary function is to plan treatments, not to provide a diagnosis of a disease or condition.
No
The device description explicitly states the system consists of a computer with graphics display, plotter output, film scanner, and backlit digitizer input, indicating it includes hardware components beyond just software.
Based on the provided text, the Varian Eclipse device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for planning radiation therapy treatments for patients. This involves analyzing diagnostic images, contouring anatomical structures, and calculating dose distributions for external beam radiation.
- Device Description: The description reinforces this by detailing its function as a computer-based system for calculating and displaying treatment plans. It mentions image analysis and dose calculation, all related to planning a medical treatment.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Varian Eclipse does not perform any such analysis of biological specimens.
The device is a medical device used for treatment planning, which is a different category than IVD.
N/A
Intended Use / Indications for Use
The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, geometrical planning, photon and electron dose calculation and plan review.
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar radiotherapy devices with xray energies from 1 -- 50MV, as well as Cobalt-60 and electron energies from 1 -- 50MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers and beam intensity modulators.
Eclipse includes also tools for treatment preparation (diagnostic image analysis, contouring and segmentation) and plan review.
As part of the VARiS Vision System, Eclipse integrates the treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patient undergoing a course of radiation therapy. The system consists of a computer with graphics display, plotter output, film scanner and backlit digitizer input.
Eclipse provides the capabilities diagnostic image analysis, contouring and segmentation and dosimetric plan review. In addition Eclipse provides tools for photon and electron dose calculation and photon dose compensation. Dose distribution from external beam, intracavitary and interstitial plans (created in BrachyVision [K992762], which can be sold as an option with Eclipse) can be combined together.
Eclipse integrates treatment planning with Varian Vision applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MRI Image Registration
Image & Contour Data import Interfaces:
DICOM including RT objects (Ethernet Local Area Network) CART format TIFF format BMP Format Configurable pure pixel data PortalVision Mark 1&2 (not used with Protons) Varian CT Option Electromagnetic Digitizer Film Scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Eclipse 6.5, K010975
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.
BrachyVision [K992762]
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUN 2 4 2003
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
March 27, 2003
Submitter's Name:
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Person:
Vy Tran Manager, Regulatory Affairs Phone (650) 424-5731 FAX (650) 842-5040 E-mail vy.tran@varian.com
Device Name:
Eclipse
Classification Name:
System, Planning, Radiation Therapy Treatment
Predicate Device:
Eclipse 6.5, K010975
1
Product Description:
The Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patient undergoing a course of radiation therapy. The system consists of a computer with graphics display, plotter output, film scanner and backlit digitizer input.
Eclipse provides the capabilities diagnostic image analysis, contouring and segmentation and dosimetric plan review. In addition Eclipse provides tools for photon and electron dose calculation and photon dose compensation. Dose distribution from external beam, intracavitary and interstitial plans (created in BrachyVision [K992762], which can be sold as an option with Eclipse) can be combined together.
Eclipse integrates treatment planning with Varian Vision applications.
Intended Use:
The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, geometrical planning, photon and electron dose calculation and plan review.
Technological Characteristics:
Specification Comparison Chart
| Predicate Device | New Device |
|---|---|
| Varian Eclipse 6.5 (build 7.0) K010975 | Varian Eclipse |
| The Varian Eclipse device is a treatment | |
| planning system used for diagnostic image | |
| analysis, contouring & segmentation, | |
| geometrical planning, photon and electron | |
| dose calculation and plan review. | The Varian Eclipse device is a treatment |
| planning system used for diagnostic image | |
| analysis, contouring & segmentation, | |
| geometrical planning, photon and electron | |
| dose calculation and plan review. | |
| 1. General Software | 1. General Software |
| Coplanar and Non-coplanar Photon Beams | Coplanar and Non-coplanar Photon Beams |
| Coplanar and Non-coplanar Electron Beams | Coplanar and Non-coplanar Electron Beams |
| Isocentric, fixed SSD and Arc fields | Isocentric, fixed SSD and Arc fields |
| Asymmetric collimators | Asymmetric collimators |
| Multileaf Collimators | Multileaf Collimators |
| Cerrobend blocks | Cerrobend blocks |
| Hard Wedges, Dynamic Wedge and Enhanced | |
| Dynamic Wedge | Hard Wedges, Dynamic Wedge and Enhanced |
| Dynamic Wedge | |
| Oblique Planar Reconstruction | Oblique Planar Reconstruction |
| Dose Volume Histograms | Dose Volume Histograms |
| 3D Graphics Visualization | 3D Graphics Visualization |
| Configurable Treatment Unit Scales | Configurable Treatment Unit Scales |
| Digitally Reconstructed Radiographs | Digitally Reconstructed Radiographs |
| Fully Integrated to the Varis Vision database | Fully Integrated to the Varis Vision database |
| VariSource afterloader plan summation | VariSource afterloader plan summation |
| Physical Compensators | Physical Compensators |
| Plan library to store and retrieve common | Plan library to store and retrieve common |
| plans | plans |
| 2. Contouring Tools | 2. Contouring Tools |
| Freehand | Freehand |
| Rubberband | Rubberband |
| Pre-defined geometrical shapes | Pre-defined geometrical shapes |
| Eraser | Eraser |
| Cut and Paste | Cut and Paste |
| Rotate | Rotate |
| Scale | Scale |
| Mirror | Mirror |
| Automatic Contour | Automatic Contour |
| 3D Automargin | 3D Automargin |
| 3. Display | 3. Display |
| Graphical User Interface | Graphical User Interface |
| Property Sheets for easy screen navigation | Property Sheets for easy screen navigation |
| Toolbars for frequently used operations | Toolbars for frequently used operations |
| Layer window to show and select | Layer window to show and select |
| fields/accessories | fields/accessories |
| Open GL Graphics support | Open GL Graphics support |
| 4. Geometric Planning | 4. Geometric Planning |
| CT Simulation functionality | CT Simulation functionality |
| Isocenter Placement | Isocenter Placement |
| Automatic via target geometry | Automatic via target geometry |
| Block Fitting | Block Fitting |
| MLC Fitting | MLC Fitting |
| "Pick & Grab" Interactive Field Placement | "Pick & Grab" Interactive Field Placement |
| Field Parameters Spreadsheet | Field Parameters Spreadsheet |
| 5. Visualization | 5. Visualization |
| Image Planes: | Image Planes: |
| ● Axial | ● Axial |
| ● Coronal | ● Coronal |
| ● Sagittal | ● Sagittal |
| ● Oblique | ● Oblique |
| CT/MRI Image Registration | CT/MRI Image Registration |
| Beam Overlays | Beam Overlays |
| MLC Overlays | MLC Overlays |
2
3
| Cerrobend Block Overlays | Cerrobend Block Overlays | ||
|---|---|---|---|
| 3D View: | 3D View: | ||
| MLC Blocks Beams Wedges Anatomical Structures | MLC Blocks Beams Wedges Anatomical Structures | ||
| Beam's Eye View (BEV): | Beam's Eye View (BEV): | ||
| Field Geometry Anatomical Structures Wedge Orientation MLC Leaves Digitally Reconstructed Radiograph (DRR) | Field Geometry Anatomical Structures Wedge Orientation MLC Leaves Digitally Reconstructed Radiograph (DRR) | ||
| Anatomical Structure Visualization: | Anatomical Structure Visualization: | ||
| Wire Frame Translucent Solid User Definable Color | Wire Frame Translucent Solid User Definable Color | ||
| Machine Orientation Icon | Machine Orientation Icon | ||
| Patient Orientation Icon | Patient Orientation Icon | ||
| Measurement Tools: | Measurement Tools: | ||
| CT/Pixel Values Distances Angles Areas Volumes Point dose Line dose | CT/Pixel Values Distances Angles Areas Volumes Point dose Line dose | ||
| 6. Calculation Algorithms | 6. Calculation Algorithms | ||
| Photons: | Photons: | ||
| Energy range: 1MV – 50MV Single Pencil Beam Convolution Model MU Calculations | Heterogeneity Corrections: | Energy range: 1MV – 50MV Single Pencil Beam Convolution Model MU Calculations | Heterogeneity Corrections: |
| o Batho Power Law | o Batho Power Law | ||
| o Equivalent TAR | o Equivalent TAR | ||
| Electrons: | Electrons: | ||
| Energy range: 1MeV – 50MeV Generalized Gaussian Pencil Beam Model | Energy range: 1MeV – 50MeV Generalized Gaussian Pencil Beam Model Electron Monte Carlo dose calculation model (based on Macro Monte Carlo algorithm) | ||
| Non-CT based Irregular field planning support | Non-CT based Irregular field planning support | ||
| Protons: None | Protons: None | ||
| 7. Import/Export Features | 7. Import/Export Features | ||
| Image & Contour Data import Interfaces: | Image & Contour Data import Interfaces: | ||
| DICOM including RT objects (Ethernet Local Area Network) CART format TIFF format BMP Format Configurable pure pixel data PortalVision Mark 1&2 (not used with Protons) Varian CT Option Electromagnetic Digitizer Film Scanner | DICOM including RT objects (Ethernet Local Area Network) CART format TIFF format BMP Format Configurable pure pixel data PortalVision Mark 1&2 (not used with Protons) Varian CT Option Electromagnetic Digitizer Film Scanner | ||
| Export Interfaces: | Export Interfaces: | ||
| DICOM including RT objects MLC Shaper files Blocks and Compensator data to Par Scientific Plan and dose data to Picker AcQSim Integrated with Varis verification system ASCII File to Laser System Varian CadPlan Plus 6.0 | DICOM including RT objects MLC Shaper files Blocks and Compensator data to Par Scientific Plan and dose data to Picker AcQSim Integrated with Varis verification system ASCII File to Laser System Varian CadPlan Plus 6.0 | ||
| 8. Plan Review | 8. Plan Review | ||
| 2D Plan Display: | 2D Plan Display: | ||
| Isodose Lines Color Wash | Isodose Lines Color Wash | ||
| 3D Plan Display: | 3D Plan Display: | ||
| Isodose Surfaces (Wire Cage, Translucent, Solid) Dose Color Wash Organ Surface Dose | Isodose Surfaces (Wire Cage, Translucent, Solid) Dose Color Wash Organ Surface Dose | ||
| Dose Volume Histograms: | Dose Volume Histograms: | ||
| Cumulative Differential | Cumulative Differential | ||
| Plan Comparison: | Plan Comparison: | ||
| DVH Visual side by side | • DVH | DVH Visual side by side | • DVH |
| • Visual side by side | • Visual side by side | ||
| • Dose difference | • Dose difference | ||
| Plan Summing | Plan Summing | ||
| • External plans | • External plans | ||
| • Brachytherapy plans | • Brachytherapy plans |
4
"
5
| 9. Plan Output – Hardcopy | 9. Plan Output - Hardcopy |
|---|---|
| Graphics window screen dump | Graphics window screen dump |
| Treatment plan output includes: | Treatment plan output includes: |
| • Patient administration data | • Patient administration data |
| • Time stamp | • Time stamp |
| • Field parameters | • Field parameters |
| • Dose parameters | • Dose parameters |
| • Patient orientation | • Patient orientation |
| • Plot scale | • Plot scale |
| • Treatment protocol list | • Treatment protocol list |
| User Configurable hardcopy layouts | User Configurable hardcopy layouts |
| Configurable Treatment Unit Scales | Configurable Treatment Unit Scales |
| Letter, tabloid, A4 and A3 paper sizes | Letter, tabloid, A4 and A3 paper sizes |
| Plotting of BEV image at user defined MAG factor | Plotting of BEV image at user defined MAG factor |
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2003
Ms. Vy Tran Regulatory Affairs Manager VARIAN Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K030981 Trade/Device Name: Eclipse Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: March 27, 2003 Received: March 28, 2003
Dear Ms. Tran:
This letter corrects our substantially equivalent letter of June 24, 2003 regarding the incorrect product code. In the original letter the product code was stated as LNH and MUJ, it should have been just MUJ. This error has been corrected in our files.
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 (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.
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
7
Page 2 - Ms. Tran
CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel A. Legroom
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known): Kf Device Name: Eclipse
Indications For Use:
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar radiotherapy devices with xray energies from 1 -- 50MV, as well as Cobalt-60 and electron energies from 1 -- 50MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers and beam intensity modulators.
Eclipse includes also tools for treatment preparation (diagnostic image analysis, contouring and segmentation) and plan review.
As part of the VARiS Vision System, Eclipse integrates the treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
Nancy C. Hogdon
Division of Renro and Radiological Devi 10(k) Number