HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

K071992 · Varian Medical Systems · IYE · Aug 15, 2007 · Radiology

Device Facts

• Record ID: K071992
• Device Name: HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory X-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are controlled as a function of the accelerator dose fraction or gantry angle. The intended use is to assist the clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Device Story

The High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory for Varian Trilogy Tx and Trilogy linear accelerators. It features 120 leaves, with finer-width leaves in the center section to provide higher-resolution shaping of radiation fields. The device is operated by clinicians in a clinical setting to deliver external beam radiation. It shapes the X-ray field perimeter in either static or dynamic modes, with dynamic shapes controlled by accelerator dose fraction or gantry angle. By enabling higher-definition shaping, the device allows for more precise targeting of small volumes during SRS and SRT, potentially improving the sparing of surrounding normal tissue and critical organs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory X-ray collimator for linear accelerators; 120-leaf configuration with finer-width leaves in the center section; supports static and dynamic field shaping; mounts to Varian Trilogy Tx and Trilogy systems.

Indications for Use

Indicated for patients undergoing external beam radiation therapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), requiring precise shaping of radiation fields to target volumes while sparing surrounding healthy tissue and critical organs.

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 Millennium Multileaf Collimator (K050442)

Submission Summary (Full Text)

{0}------------------------------------------------

K071992

#### 510(k) Summary

AUG 1 5 2007

The information below is provided for the High-Definition 120 Multileaf Collimator (HD120 MLC), following the format of 21 CFR 807.92.

- Varian Medical Systems 1. Submitter: 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]
- 2. Name of the Device: High-Definition 120 Multileaf Collimator (HD120 MLC) High-Definition 120 Multileaf Collimator (HD120 MLC) Trade / Proprietary Name: Common or Usual Name: Accessory to Medical Linear Accelerator Classification Name: Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 TYE
- 3. Predicate Devices to claim substantial equivalence: Varian Medical Systems Millennium Multileaf Collimator - K050442
- 4. Description of the Device:

The High-Definition 120 Multileaf Collimator (HD120 MLC) provides higher resolution via finer width leaves in the center section of the treatment field. The total number of leaves remains the same at 120. As a result of the finer leaves, the treatment field has been modified from 40 cm in width. The length of the treatment field remains unchanged.

The objective of the area occupied by the finer leaves is to provide for higher definition shaping of treatment fields. These fields are primarily directed at small targets during single fraction Stereotactic Radiosurgery (SRS) and multi-fraction Stereotactic Radiotherapy (SRT).

- 5. Intended Use Statement
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory X-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are controlled as a function of the accelerator dose fraction or gantry angle. The intended use is to assist the clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

{1}------------------------------------------------

#### Indications for Use Statement 6.

The Varian High-Definition120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

### 7. Substantial Equivalence

The High-Definition 120 Multileaf Collimator (HD120 MLC) submission illustrates substantial equivalence to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or waves emanating from a single point.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# AUG 1 5 2007

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

Re: K071992

Trade/Device Name: High-Definition 120 Multileaf Collimator (HD120 MLC) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 19, 2007 Received: July 20, 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, 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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line at the bottom of the logo.

tocting and Promoting Publio Hoalth

{3}------------------------------------------------

Page 2 -

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with the "I" stylized to resemble a person. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is black and white.

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):

K071942

Device Name:

High-Definition 120 Multileaf Collimator (HD120 MLC)

Indications for Use:

The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-the-counter
(Per 21 CFR § 801.109)

JWhang
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071992