MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM

K091492 · Varian Medical Systems, Inc. · MUJ · Jun 18, 2009 · Radiology

Device Facts

• Record ID: K091492
• Device Name: MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jun 18, 2009
• 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 patient anatomical 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. Clinicians use the software to calculate dose distributions and optimize treatment plans, which are then used to guide radiation delivery equipment. The device benefits patients by enabling precise, individualized radiation therapy planning, potentially improving treatment accuracy and clinical outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based software system for radiotherapy treatment planning. Supports photon, electron, and proton external beam modalities and brachytherapy. Includes specialized algorithm for proton eye treatment planning. Operates as a standalone software application for clinical use.

Indications for Use

Indicated for patients with malignant or benign diseases requiring radiotherapy. Used for planning external beam irradiation (photon, electron, proton) and internal irradiation (brachytherapy). The Proton Eye algorithm is indicated for planning proton treatment 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 (K073020)

Submission Summary (Full Text)

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K091492

JUN 18 2009

## Premarket Notification 510(k) Summary

Submitter's Name:

Varian Medical Systems, Inc. 3100 Hansen Way E-110 Palo Alto, CA 94304 . Contact Name: Vy Tran Phone: [phone] Fax: [phone] Date: May 2009

Eclipse TPS

Proprietary Name:

Classification Name:

Predicate Devices:

Device Description:

Eclipse Treatment Planning System

Medical charged-particle radiation therapy system, 21 CFR §892.5050, MUJ, Class II

Common/Usual Name:

Eclipse Treatment Planning System, K073020

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 computerbased 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.

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.

Technological Characteristics:

Statement of

Indications for Use:

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 2009

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

Re: K091492

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: May 14, 2009 Received: May 20, 2009

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 (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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Eclipse Treatment Planning System (TPS)

## Indications for Use

510(k) Number (if known):

Device Name: Eclipse Treatment Planning System

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sig -Off

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

(Posted November 13, 2003)