ECLIPSE

K030981 · Varian Medical Systems, Inc. · LNH · Jun 24, 2003 · Radiology

Device Facts

• Record ID: K030981
• Device Name: ECLIPSE
• Applicant: Varian Medical Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Eclipse is a computer-based radiation therapy treatment planning system. It ingests diagnostic images (CT/MRI) via DICOM, film scanners, or digitizers. Clinicians use the system for image analysis, contouring, segmentation, and geometrical planning. The system calculates photon and electron dose distributions using pencil beam convolution and Monte Carlo models. It supports beam modifiers, multileaf collimators, and intensity modulation. Outputs include treatment plans, dose volume histograms, and digitally reconstructed radiographs (DRRs) for verification. Used in clinical settings by radiation oncologists and medical physicists to design and review treatment plans. The system integrates with the Varis Vision database to manage the therapy process. By providing precise dose calculations and visualization, it assists in optimizing radiation delivery to target volumes while sparing healthy tissue, potentially improving patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based planning system; supports photon (1-50MV) and electron (1-50MeV) energies. Algorithms include Single Pencil Beam Convolution and Macro Monte Carlo for electrons. Connectivity via Ethernet (DICOM, RT objects). Visualization supports 2D/3D displays, CT/MRI registration, and dose volume histograms. Hardware includes graphics display, plotter, film scanner, and digitizer.

Indications for Use

Indicated for planning photon and electron radiation therapy treatments using linear accelerators or similar devices with X-ray energies from 1-50MV, Cobalt-60, and electron energies from 1-50MeV. Supports 3D radiotherapy planning for combined modality, coplanar/non-coplanar fields, static/ARC fields, beam modifiers, and intensity modulators.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Eclipse 6.5 (K010975)

Reference Devices

• BrachyVision (K992762)
• Varian CadPlan Plus 6.0

Submission Summary (Full Text)

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# JUN 2 4 2003

K430981

## 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 [phone] FAX [phone] E-mail [e-mail]

#### Device Name:

Eclipse

#### Classification Name:

System, Planning, Radiation Therapy Treatment

#### Predicate Device:

Eclipse 6.5, K010975

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### 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<br>planning system used for diagnostic image<br>analysis, contouring & segmentation,<br>geometrical planning, photon and electron<br>dose calculation and plan review. | The Varian Eclipse device is a treatment<br>planning system used for diagnostic image<br>analysis, contouring & segmentation,<br>geometrical planning, photon and electron<br>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<br>Dynamic Wedge | Hard Wedges, Dynamic Wedge and Enhanced<br>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 |

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| 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 | | |

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"

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| 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 |

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### 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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

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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