MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM

K071873 · Varian Medical Systems, Inc. · MUJ · Aug 9, 2007 · Radiology

Device Facts

• Record ID: K071873
• Device Name: MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Eclipse TPS is a computer-based software system used by trained medical professionals to design and simulate radiation therapy treatments. It processes clinical data to plan external beam irradiation (photon, electron, proton) and brachytherapy. The system includes the Eclipse Proton Eye algorithm, specifically for planning proton treatment of eye neoplasms. Used in clinical settings, the software assists clinicians in designing treatment plans; output informs radiation therapy delivery, potentially benefiting patients by optimizing dose distribution for malignant or benign disease management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based software system for radiation therapy planning. Supports photon, electron, and proton beam external irradiation and brachytherapy. Includes specialized Proton Eye algorithm. Connectivity and hardware specifications not detailed.

Indications for Use

Indicated for patients with malignant or benign diseases requiring radiotherapy. Includes planning for external beam (photon, electron, proton) and internal (brachytherapy) irradiation. Proton Eye algorithm indicated for proton treatment planning of ocular neoplasms.

Regulatory Classification

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.

Predicate Devices

• Eclipse Treatment Planning System (K050296)

Submission Summary (Full Text)

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K071873

AUG - 9 2007

## Premarket Notification 510(k) Summary

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: July 3, 2007 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Eclipse Treatment Planning System |
| Classification Name: | Medical charged-particle radiation therapy system,<br>21 CFR 892.5050, MUJ, Class II |
| Common/Usual Name: | Eclipse TPS |
| Predicate Devices: | Eclipse Treatment Planning System, K050296 |
| Device Description: | The Varian Eclipse™ Treatment Planning System (Eclipse TPS)<br>(K050296) provides software tools for planning the treatment of<br>malignant or benign diseases with radiation. Eclipse TPS is a<br>computer-based software device used by trained medical<br>professionals to design and simulate radiation therapy<br>treatments. Eclipse TPS is capable of planning treatments for<br>external beam irradiation with photon, electron, and proton<br>beams, as well as for internal irradiation, (brachytherapy)<br>treatments. |
| Statement of<br>Indications for Use: | The Eclipse Treatment Planning System (Eclipse TPS) is used to<br>plan radiotherapy treatments for patients with malignant or<br>benign diseases. Eclipse TPS is used to plan external beam<br>irradiation with photon, electron and proton beams, as well as for<br>internal irradiation (brachytherapy) treatments. In addition, the<br>Eclipse Proton Eye algorithm is specifically indicated for<br>planning proton treatment of neoplasms of the eye. |
| Technological<br>Characteristics: | Refer to the Substantial Equivalence Comparison Chart. |

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text surrounding a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center features three abstract human figures or forms, arranged in a vertical stack.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## AUG - 9 2007

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K071873

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 3, 2007 Received: July 6, 2007

Dear Ms. Tran:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/1/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" inside a circle. Below the logo, there is a phrase that reads "Protecting and Promoting Public Health". The text is written in a decorative, cursive font. The image appears to be a scan or photocopy, as the text is slightly blurred and there are some artifacts.

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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); 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 begin 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C Hodgon

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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| | Indications for Use |
|---------------------------|---------------------|
| 510(k) Number (if known): | K071873 |

Eclipse Treatment Planning System Device Name:

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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(Posted November 13, 2003)