TRUEBEAM

K111106 · Varian Medical Systems, Inc. · IYE · Aug 18, 2011 · Radiology

Device Facts

• Record ID: K111106
• Device Name: TRUEBEAM
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TrueBeam ™ system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Story

TrueBeam Radiotherapy Delivery System is a medical linear accelerator; integrates photon, electron, and diagnostic kV X-ray radiation beam-producing components. System installed in radiation-shielded vault; operated via control console outside treatment room. Device delivers stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions. Enhancements over predicate include expanded energy range (4-25MV), LaserGuard II system, and supplemental capacitive collision detection system (kV CCDS) on kV source. Clinicians use system to target radiation; output enables precise treatment delivery to patient lesions/tumors; benefits include improved targeting and safety during radiotherapy procedures.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed conformance to requirements specifications and proper functioning of hazard safeguards.

Technological Characteristics

Medical linear accelerator; photon, electron, and kV X-ray radiation sources. Energy range: 4-25MV. Features: LaserGuard II, supplemental capacitive collision detection system (kV CCDS) on kV source. System consists of radiation-shielded vault component and external control console.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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

• Trilogy Mx Radiotherapy System and Accessories (K092871)

Submission Summary (Full Text)

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## Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System

AUG 1 8 2011

The following information is provided following the format of 21 CFR 807.92.

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: June 2011 |
| Proprietary Name: | TrueBeam™ |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: 90 IYE |
| Common/Usual Name: | TrueBeam Radiotherapy Delivery System |
| Predicate Device: | Trilogy Mx Radiotherapy System and Accessories: K092871 |
| Device Description: | The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator<br>that integrates the previously cleared Trilogy Radiotherapy system and<br>associated accessories into a single device. |
| | The system consists of two major components, a photon, electron, and<br>diagnostic kV X-ray radiation beam-producing component that is installed in a<br>radiation-shielded vault and a control console area located outside the<br>treatment room. |
| Intended Use Statement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery and<br>precision radiotherapy for lesions, tumors, and conditions anywhere in the<br>body where radiation treatment is indicated. |
| Indications for Use<br>Statement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery and<br>precision radiotherapy for lesions, tumors, and conditions anywhere in the<br>body where radiation treatment is indicated. |

Technological Characteristics: Significant changes to the predicate device are listed below.

| Feature | Cleared device | Device with change |
|---------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Energy used | 6-25MV | 4-25MV |
| LaserGuard II | . No | Yes |
| Proximity detection | Touchguards present on kV source,<br>kV detector, positioning units | Addition of supplemental capacitive collision<br>detection system (kV CCDS) on kV source |

## Summary of performance testing:

Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its wing.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

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

AUG 1 8 2011

Rc: K111106

Trade/Device Name: TrueBeam Radiotherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 7, 2011 Received: July 8, 2011

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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,

Mary SPatel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## TrueBeam Radiotherapy Treatment System

## Indications for Use

510(k) Number (if known): __ | | | | 06 ______________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

510K

Division of Rediological Devic Office of In Vitro Diagnostic Device Evaluation and Safety

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