OPTICAL GUIDANCE PLATFORM

K071360 · Varian Medical Systems, Inc. · IYE · Jun 8, 2007 · Radiology

Device Facts

• Record ID: K071360
• Device Name: OPTICAL GUIDANCE PLATFORM
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 8, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

Device Story

Optical Guidance Platform (OGP) facilitates patient positioning for stereotactic radiosurgery or radiotherapy; utilizes high-precision infrared cameras to detect stereotactic localization devices equipped with infrared markers (LEDs or reflective markers) attached to patient or immobilization hardware; optional ultrasound tracking module enables soft tissue target definition for extracranial procedures; system integrates with charged particle accelerators; provides spatial data to clinicians to ensure accurate target alignment; enhances treatment precision for cranial and extracranial lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

System utilizes infrared camera-based optical tracking of markers (LED or reflective) attached to patient or immobilization devices. Includes optional ultrasound tracking for soft tissue. Designed for integration with charged particle accelerators for radiotherapy/radiosurgery. Class II medical device (21 CFR 892.5050).

Indications for Use

Indicated for patients requiring precise positioning of treatment targets for stereotactic radiosurgery or radiotherapy of cranial or extracranial lesions.

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

• SNT Stereotactic Localization System (K971675)
• SNT Linac Accessories (K971893)
• Patient Positioning System (K980750)
• Biteblock Localization and Positioning System (K981346)
• Head/Neck Application (K994355)
• RadioCameras Extracranial System (K000246)

Submission Summary (Full Text)

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

K07/360

## Premarket Notification 510(k) Summary

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: May 11, 2007 | JUN - 8 2007 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Proprietary Name: | Optical Guidance Platform | |
| Classification Name: | Medical charged-particle radiation therapy system,<br>21 CFR 892.5050, 90 IYE, Class II | |
| Common/Usual Name: | Optical Guidance Platform | |
| Predicate Devices: | SNT Stereotactic Localization System, K971675<br>SNT Linac Accessories, K971893<br>Patient Positioning System, K980750<br>Biteblock Localization and Positioning System, K981346<br>Head/Neck Application, K994355<br>RadioCameras Extracranial System, K000246 | |
| Device Description: | The Optical Guidance Platform provides a method of positioning the<br>patient for either radiosurgery or radiotherapy by using high precision<br>infrared camera to detect the location of the stereotactic localization<br>device comprised of infrared markers (either LED's or reflective<br>markers) attached to the patient or stereotactic immobilization device.<br>It is designed to provide patient positioning for intracranial and<br>extracranial targets. It also provides an option for ultrasound tracking<br>of soft tissue to more accurately define the target in extracranial<br>radiosurgery and radiotherapy. | |
| Statement of<br>Indications for Use: | Varian Medical System's Optical Guidance Platform (OGP) is for use<br>with a charged particle accelerator to perform precise positioning of<br>treatment target for stereotactic radiosurgery or radiotherapy treatments<br>on cranial or extracranial lesions. | |
| Technological<br>Characteristics: | Refer to the Substantial Equivalence Comparison Chart. | |

"

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

Image /page/1/Picture/0 description: The image shows a circular logo with the words "Public Health & Human Services, USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird. The image is in black and white and appears to be a scan or photocopy, as the text and symbol are slightly pixelated.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 8 2007

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

Re: K071360

Trade/Device Name: Optical Guidance Platform Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 11, 2007 Received: May 15, 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/1/Picture/10 description: The image shows a circular logo with the text "1876-1976" at the top. Below the text is a large, stylized "PA" in bold letters. The word "Centennial" is written below the letters, and there are three stars below the word. The logo appears to be a commemorative emblem, possibly for a centennial celebration related to Pennsylvania.

noting Publio Hoalth rolating and Of

{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 Cbrogdon

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

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

## Indications for Use

510(k) Number (if known): K07 | 36 0

Device Name:

Indications for Use:

Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices VD71360

5 1 O(k) Number

Page of

(Posted November 13, 2003)