ECLIPSE TREATMENT PLANNING SYSTEM

K050296 · Varian Medical Systems · MUJ · Nov 3, 2005 · Radiology

Device Facts

• Record ID: K050296
• Device Name: ECLIPSE TREATMENT PLANNING SYSTEM
• Applicant: Varian Medical Systems
• Product Code: MUJ · Radiology
• Decision Date: Nov 3, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 Eyc algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Device Story

Eclipse Treatment Planning System (TPS) is a software-based tool for radiation therapy planning. Used by trained medical professionals in clinical settings to design and simulate treatments for malignant or benign diseases. Inputs include patient anatomical data; system processes data to calculate dose distributions for external beam (photon, electron, proton) and brachytherapy. Includes specialized Proton Eye algorithm for ocular neoplasms. Output is a treatment plan used by clinicians to guide radiation delivery, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based software for radiation therapy planning. Supports photon, electron, and proton external beam and brachytherapy modalities. 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 external beam irradiation (photon, electron, proton) and internal irradiation (brachytherapy). Proton Eye algorithm indicated for proton treatment of neoplasms of the eye.

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

• Varian Eclipse (K041403)
• Varian Helios (K021268)
• Varian ProtonVision (K002312)
• Varian BrachyVision (K992762)

Submission Summary (Full Text)

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# ATTACHMENT B

K050296

### NOV - 3 2005

#### Premarket Notification {510(k)} Summary

Submitter's Name: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date: January 31, 2005

Proprietary Name: Eclipse Treatment Planning System (TPS)

> Classification Name: System, planning, radiation therapy treatment, 21 CFR 892.5050 Class II Common/Usual Name: Eclipse

### Predicate Device(s): 1. Varian Eclipse, K041403

- 2. Varian Helios, K021268
- 3. Varian ProtonVision, K002312
- 4. Varian BrachyVision, K992762

Product 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 treatment for external beam irradiation with photons, 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.

Statement of 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 Eyc algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Technological Characteristics: Refer to the "Substantial Equivalence Comparison Chart", Tab 8.

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Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized depiction of an eagle or other bird-like figure, with three curved lines representing its wings or body. The logo is black and white.

NOV - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050296

Trade/Device Name: Eclipse (TPS) Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MOS Dated: October 13, 2005 Received: October 17, 2005

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.

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.

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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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# ATTACHMENT A

PAGE 1 of 1

510(k) Number (if known): K050296
Device Name: Eclipse

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 irr clicting (brachytherapy) treatments. In addition, the Edinse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

(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*

✓

Marcy C. Gordon

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