TRILOGY SYSTEM WITH RAPIDARC

K072916 · Varian Medical Systems, Inc. · IYE · Nov 9, 2007 · Radiology

Device Facts

• Record ID: K072916
• Device Name: TRILOGY SYSTEM WITH RAPIDARC
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trilogy ™ System with RapidArc is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Device Story

Trilogy System with RapidArc is a radiotherapy delivery system. Modifications enable RapidArc treatment fields, which simultaneously vary radiation intensity and gantry rotation speed. Used in clinical settings by trained professionals to deliver stereotactic radiosurgery and precision radiotherapy. Output is controlled radiation delivery to lesions, tumors, or conditions. Benefits include precise treatment delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological modifications to the predicate system.

Technological Characteristics

Medical charged-particle radiation therapy system (21 CFR 892.5050). Features gantry rotation and variable radiation intensity delivery. System is a modification of the existing Trilogy platform.

Indications for Use

Indicated for 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

• Varian Trilogy Tx Radiotherapy System (K070094)

Reference Devices

• K061140
• K033343

Submission Summary (Full Text)

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K072916

## 510(k) Summary

The information below is provided for the Modifications to the Trilogy Radiotherapy Delivery System known as Trilogy System with RapidArc, following the format of 21 CFR 807.92.

- Submitter: Varian Medical Systems 1. 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 . Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]
**NOV**

*9 2007*

| 2. Name of the Device: | Trilogy™ System with RapidArc |
|---------------------------|-----------------------------------------------------------------------------------|
| Trade / Proprietary Name: | Trilogy™ System with RapidArc |
| Common or Usual Name: | Trilogy™ System with RapidArc |
| Classification Name: | Medical Charged Particle Radiation Therapy System<br>21 CFR §892.5050<br>Class II |
| Product Code: | 90 IYE |

- 3. Predicate Device to claim substantial equivalence: Varian Trilogy Tx Radiotherapy System -K070094
- 4. Description of the Device:

The Trilogy System modifications enable the delivery a RapidArc treatment fields that simultaneously vary the intensity of radiation and gantry rotation speed.

All other features of the Trilogy System and remain as cleared by K061140, K033343, and K070094.

- Intended Use Statement ર.
The Trilogy ™ System with RapidArc is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

- Indications for Use Statement 6.
The Trilogy™ System with RapidArc is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

- 7. Substantial Equivalence
Trilogy ™ System with RapidArc submission illustrates substantial equivalence to the predicate device.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way. M/S/E-110 PALO ALTO CA 94304

Re: K072916

Trade/Device Name: Trilogy System with RapidArc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 11, 2007 Received: October 12, 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, 1796, 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 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.

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours,

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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KC729/6

Image /page/3/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "i" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, conveying a sense of trust and reliability.

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA

Tel [phone] www.varian.com

## Indications for Use Statement

510(k) Number (if known):

KC729/6

Device Name:

Trilogy TM System with RapidArc

The Trilogy ™ System with RapidArc is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗ OR Over-the-counter **__**
(Per 21 CFR § 801.109)

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

Radiological Devices
510(k) Number K072914