VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE

K973889 · Varian Medical Systems, Inc. · IYE · Nov 21, 1997 · Radiology

Device Facts

• Record ID: K973889
• Device Name: VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian MultiLeaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In this the MLC performs the same function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac® linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.

Device Story

Varian MultiLeaf Collimator (MLC) is an x-ray beam-shaping accessory for Varian Clinac linear accelerators. Device consists of 52 or 80 collimator leaves (26 or 40 opposed pairs) positioned to create irregular treatment fields. Dynamic arc therapy feature allows continuous, automated leaf repositioning synchronized with Clinac gantry rotation during arc therapy. Operated by radiation oncologists/technicians in clinical settings. Input is pre-existing treatment schedule; output is dynamic beam shaping corresponding to beam's eye view of target volume. Benefits include improved sparing of normal tissue and critical organs compared to static fields or customized shadow blocks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardware identical to predicate Varian MLCs. Consists of 52 or 80 collimator leaves (opposed pairs). Mounts to Varian Clinac linear accelerator. Software-controlled dynamic leaf positioning synchronized with gantry rotation.

Indications for Use

Indicated for radiation oncology patients requiring radiation delivery to defined target volumes while sparing surrounding normal 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 MultilLeaf Collimator (K926449)
• Varian MultilLeaf Collimator (K943224)
• BrainLAB micro-MultiLeaf Collimator (K970586)

Submission Summary (Full Text)

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973889

## varian®

## Summary of Safety and Effectiveness Information

NOV 2 | 1997

- Varian Oncology Systems 1. Submitter: 3045 Hanover Street Palo Alto, CA 94304
Charles H. Will, Manager Contact: Regulatory Compliance & Safety Phone [phone] [phone] FAX [e-mail]

October 13, 1997 Prepared:

- Varian MultiLeaf Collimator with dynamic arc therapy feature 2. Device Name:
- Varian MultilLeaf Collimator (K926449, K943224) 3. Predicate BrainLAB micro-MultiLeaf Collimator (K970586) Devices:
- The Varian MultiLeaf Collimator (MLC) is an x-ray collimator 4. Description: designed to be mounted on a Varian Clinac® radiation therapy linear accelerator beneath the standard field defining collimator jaws to provide complex beam shaping supplementary to the Clinac's rectangular fields. It contains either 52 or 80 collimator leaves (26 or 40 opposed pairs of leaves), each of which can be positioned individually in order to provide an irregularly shaped treatment field that corresponds closely with the volume intended to be irradiated. With the dynamic arc therapy feature, the leaves may be continuously repositioned as a function of the Clinac gantry position during rotational irradiation (arc therapy) in order to provide dynamic conformal therapy.
- 5. Intended Use: The Varian MultiLeaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In this the MLC performs the same

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function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.

- 6. Technological The MLC version being reported in this 510(k) Notification is, Considerations: from a hardware standpoint, identical to the MLC reported in prior 510(k)'s (K926449 and K943224). The software to be provided with the MLC version notified herein contains the capability to provide dynamic arc therapy as described above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 2 1 1997

Charles Will Manager Regulatory Compliance & Safety Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304

Re: K973889

Varian Multileaf Collimator with Dynamic arc Therapy Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Will:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro. . diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yui

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use*

I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology Systems that the Product which is the subject of this premarket notification is intended to be used for the following:

> The Varian MultiLeaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In this the MLC performs the same function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac® linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.

Charles Heuiel
Charles H. Will, Mayor

Charles H. Will, Manager Regulatory Compliance & Safety

October 13, 1997
Date

"Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 809.92(a)(5).

Kg 73889

510(k) Number

David G. Segblom
Division Sign-off

Division Sign-off Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use