CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

K062514 · Accuray Incorporated · MUJ · Sep 28, 2006 · Radiology

Device Facts

• Record ID: K062514
• Device Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Applicant: Accuray Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

Device Story

CyberKnife Robotic Radiosurgery System; computer-controlled medical system for planning/performing minimally invasive stereotactic radiosurgery and precision radiotherapy. Inputs: imaging data for target localization. Operation: utilizes linear accelerator mounted on robotic manipulator; employs target locating subsystem for dynamic positioning/pointing. Tracking methods: skull tracking, fiducial tracking, skeletal structure tracking. Output: precise radiation delivery to tumors/lesions. Used in clinical settings by trained medical professionals. Benefits: enables high-precision radiation therapy for conditions throughout the body.

Technological Characteristics

Computer-controlled medical charged-particle radiotherapy system. Components: linear accelerator, robotic manipulator, target locating subsystem. Features dynamic positioning via skull, fiducial, and skeletal structure tracking. Software-based tracking algorithms.

Indications for Use

Indicated for treatment planning, image-guided stereotactic radiosurgery, and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated. Prescription use only.

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.

Submission Summary (Full Text)

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KD62514

# APPENDIX F. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# Name, Address, Phone and Fax number of the Applicant

SEP 2 8 2006

Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: [phone] Fax: [phone]

#### Contact Person

Anne Schlagenhaft

Date Prepared August 25, 2006

#### Device Name

Trade Name: CyberKnife® Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device

#### Device Description

The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.

# Intended Use

The CyberKnife Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

# Substantial Equivalence

The CyberKnife Robotic Radiosurgery System with the modified Fiducial Tracking algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent.

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray Incorporated rsto Chesapeake Terrace SUNNYVALE CA 94089

Re: K062514

Trade/Device Name: CyberKnife® Robotic Radiosurgery System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 24, 2006 Received: August 29, 2006

Dear Ms. Schlagenhaft:

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.

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Promoting Public

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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.

- * Prister 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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510(k) Number (if known): K

Device Name: CyberKnife® Robotic Radiosurgery System

Indications For Use:

The CyberKnife® Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc

OR (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Daniel A. Lippman

(Division Sion-Off Division of Reproductive and Padiological Devices 510(k) Number