TRILOGY RADIOTHERAPY DELIVERY SYSTEM

K033343 · Varian Medical Systems, Inc. · IYE · Dec 23, 2003 · Radiology

Device Facts

• Record ID: K033343
• Device Name: TRILOGY RADIOTHERAPY DELIVERY SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

Device Story

Trilogy Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator; optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), and stereotactic applications. Inputs include patient anatomical data for treatment planning; device delivers megavoltage x-ray beams. Features include Millennium multileaf collimator (MLC) with Dynamic MLC software, AS1000 electronic portal imaging device, asymmetric jaws, enhanced dynamic wedge, and remote couch motion. System provides 0.75mm radius isocenter accuracy across gantry, collimator, and table axes. Operated by clinical staff in radiation oncology settings; output used by physicians to target lesions (e.g., AVMs, tumors, metastases). Stereotactic mode supports 6MV, 1000 MU/min, max field 15cm x 15cm. Benefits include precise, high-dose delivery for complex intracranial/extracranial lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design modifications.

Technological Characteristics

Dual-energy medical linear accelerator; megavoltage x-ray source. Includes Millennium MLC, AS1000 electronic portal imaging device, asymmetric jaws, and enhanced dynamic wedge. Features remote couch motion and 0.75mm isocenter accuracy. Stereotactic mode: 6MV, 1000 MU/min, 15cm x 15cm max field. Software includes Dynamic MLC control. System is a modification of the Clinac 2300 C/D platform.

Indications for Use

Indicated for patients requiring conventional radiotherapy (3D conformal or intensity-modulated) or stereotactic radiosurgery/radiotherapy for lesions, including arteriovenous malformations, primary tumors, and metastases. Applicable for intracranial or extracranial sites; delivery may be single-session or fractionated.

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 Medical Systems' Clinac 2300 C/D (K913119)
• Brainlab Novalis Shaped Beam Surgery System (K002509)

Submission Summary (Full Text)

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K03343

DEC 2 3 2003

Image /page/0/Picture/12 description: The image shows the logo for Varian Medical Systems. The word "VARIAN" is written in all caps, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller font.

### 510(k) Summary

rian Medical Systems, Inc 100 flansen Way Palo Alto, CA 94304-1038 [phone]

The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System

- Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: [e-mail] Date summary was prepared: October 16, 2003

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

- 3. Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems' Clinac 2300 C/D, K913119
- b. Brainlab Novalis Shaped Beam Surgery System, K002509
- 4. Description of the Device: The modified 2300C/D, which will now be called the Trilogy™ Radiotherapy Delivery System, will include stereotactic functionality and remote couch motions as new features. The Trilogy™ Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The stereotactic applications include singlesession radiosurgery, fractionated stereotactic radiation therapy and intensity modulated radiosurgery. The Trilogy™ system delivers megavoltage x-ray mountated fucilobargery. The treatment of cancer. The Treatment of cancer. The Trilogy™ system includes a dynamic multileaf collimator (Millennium™ MLC with Dynamic MLC software), electronic portal imaging device (AS1000™), asymmetric jaws, enhanced dynamic wedge, a stereotactic treatment delivery mode (6MV, 1000 MU/min, maximum field size of 15cm x 15cm) and remote couch motion. There will be a 0.75mm radius isocenter for all three rotational axes, which include the gantry, collimator and table axes. The Trilogy™ system will allow for stereotactic treatments that may be intracranial or extracranial and

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consist of single-session or fractionated delivery. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary turnors and metastases.

- 5, Intended Use Statement: The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
- Summary of the Technological Characteristics: The 2300 C/D, K913119 has 6. been modified to modifications made to include radiotherapy stereotactic functionality and remote couch motions as new features. These modifications are substantially equivalent to the features of the Brainlab Novalis Shaped Beam Surgery System, K002509. The addition of these new features also result in a name change from the Varian Clinac to the Varian Trilogy™ Radiotherapy Delivery System. The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 9 of the submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 2 3 2003

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

Re: K033343 Trade/Device Name: Trilogy Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: October 16, 2003 Received: October 17, 2003

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 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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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#### PAGE 1 of 1

## 510(k) Number (if known): Device Name: Trilogy Radiotherapy Delivery System

Indications For Use:

The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactive and are intended for therapy of lesions, e.g., arteriorenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

## (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*

David Ch. Hageman.

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