TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE

K081188 · Varian Medical Systems, Inc. · IYE · Jul 14, 2008 · Radiology

Device Facts

• Record ID: K081188
• Device Name: TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trilogy ™ Radiotherapy Delivery System 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 Radiotherapy Delivery System provides stereotactic radiosurgery and precision radiotherapy. Modification adds External System Gating Interface to export beam information to external gating devices. System used in clinical radiotherapy settings by trained professionals. Output facilitates synchronization between radiation delivery and external gating systems; enables precise treatment of lesions/tumors. Benefits include improved targeting accuracy through external gating integration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical charged-particle radiation therapy system. Modification adds an interface for external gating signal export. Core system architecture, materials, and radiation delivery mechanisms remain consistent with previously cleared Trilogy system configurations.

Indications for Use

Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body requiring radiation treatment. The External System Gating Interface is indicated for exporting beam information to external gating devices.

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 (K072916)

Reference Devices

• Trilogy Radiotherapy Delivery System (K033343)
• Trilogy Radiotherapy Delivery System (K061140)
• Trilogy Radiotherapy Delivery System (K070094)

Submission Summary (Full Text)

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Korssy

# JUL 1 4 2008

### 510(k) Summary

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

- 1. Submitter: Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]
- 2. Trilogy TM with External System Gating Interface Name of the Device: Trade / Proprietary Name: Trilogy ™ Radiotherapy Delivery System Common or Usual Name: Trilogy TM Radiotherapy Delivery System Classification Name: Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 TYE™
- 3. Predicate Device to claim substantial equivalence: Varian Trilogy Tx Radiotherapy System-K072916
- 4. Description of the Device:

The Trilogy System modifications enable the export of beam information to external gating devices.

All other features of the Trilogy System and remain as cleared by K033343, K061140, K070094 and 072916.

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

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

The External System Gating Interface is indicated for use in exporting beam information to external gating devices.

- 7. Substantial Equivalence
The submission for the Trilogy™ with External System Gating Interface illustrates substantial equivalence to the predicate device.

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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 features a stylized caduceus, which is a symbol of medicine, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 4 2008

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

Re: K081188

Trade/Device Name: Trilogy™ with External System gating Interface Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 25, 2008 Received: April 28, 2008

#### 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 vour 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/cdrb/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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo features the word "VARIAN" in a bold, sans-serif font, with a stylized figure replacing the "I" in Varian. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font.

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):

K081188

Device Name:

Trilogy TM with External System Gating Interface

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

The External System Gating Interface is indicated for use in exporting beam information to external gating devices.

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

OR

Prescription Use
(Per 21 CFR § 801.109)

Over-the-counter

Hogai M. Whang

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