TRILOGY MX

K092871 · Varian Medical Systems, Inc. · IYE · Nov 30, 2009 · Radiology

Device Facts

• Record ID: K092871
• Device Name: TRILOGY MX
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trilogy Mx 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

Trilogy Mx is a medical linear accelerator for stereotactic radiosurgery and precision radiotherapy. System integrates photon, electron, and diagnostic kV X-ray radiation beam-producing components. Device installed in radiation-shielded vault; operated via control console outside treatment room. Clinicians use system to deliver targeted radiation to lesions, tumors, and conditions throughout body. System combines previously cleared Trilogy Radiotherapy system and accessories into single device. Benefits include precise radiation delivery for indicated clinical conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and integration of previously cleared components.

Technological Characteristics

Medical linear accelerator; photon, electron, and diagnostic kV X-ray radiation beam-producing components. System consists of radiation-shielded vault unit and external control console. Integrates previously cleared Trilogy system components.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery and 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 Radiotherapy System and Accessories (K050442)

Reference Devices

• K072916
• K042720
• K063270
• K081036
• K003636
• K071992

Submission Summary (Full Text)

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092871

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

NOV 30 2009

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

| 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: 16th September 2009

21 CFR 892.5050, Class II Product Code: 90 IYE

Medical charged-particle radiation therapy system

Trilogy Mx Radiotherapy Delivery System

Trilogy Radiotherapy System and Accessories:

Trilogy Mx™

K050442

Proprietary Name:

Classification Name:

Common/Usual Name:

Predicate Devices:

Device Description:

The Trilogy Mx™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

K072916, K042720, K063270, K081036, K003636, K071992,

The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

The Trilogy Mx™ system is intended to provide stereotactic radiosurgery

The Trilogy Mx™ system is intended to provide stereotactic radiosurgery

and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

and precision radiotherapy for lesions, tumors, and conditions anvwhere in the body where radiation treatment is indicated.

Statement of Intended Use

Statement of Indications for Use:

Technological Characteristics:

Refer to the Substantial Equivalence Comparison Chart

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Public Health Service

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

NOV 3 0 2009

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

Re: K092871

Trade/Device Name: Trilogy Mx™ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system and the comments of the comments of the comments of Regulatory Class: II Product Code: IYE Dated: September 16, 2009 Received: September 18, 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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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## Indications for Use

K092871 510(k) Number (if known): .

Device Name:_____Trilogy Mx

Indications For Use:

Trilogy Mx 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 × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

logm 722

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

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