CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

K041315 · Accuray, Inc. · IYE · Jun 10, 2004 · Radiology

Device Facts

• Record ID: K041315
• Device Name: CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
• Applicant: Accuray, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CyberKnife System is a computer-controlled medical device for stereotactic radiosurgery and precision radiotherapy. System components include a radiation generator (linear accelerator), a robotic manipulator, and a target-locating subsystem. Input data consists of medical images used for treatment planning and real-time tracking data. The device employs skull, fiducial, and skeletal structure tracking algorithms to dynamically position and point the linear accelerator at the treatment target. Output is the precise delivery of radiation to lesions or tumors. Used in clinical settings by trained professionals; the system enables minimally invasive treatment by adjusting for patient movement during therapy. Healthcare providers use the system to plan and execute radiation delivery, potentially improving treatment accuracy and patient outcomes for various body conditions.

Technological Characteristics

Medical linear accelerator system; computer-controlled robotic manipulator; integrated target-locating subsystem; utilizes skull, fiducial, and skeletal structure tracking for dynamic positioning.

Indications for Use

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

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)

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

# JUN 1 0 2004 APPENDIX F. 510(k) SUMMA

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

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

#### Contact Person

Anne Schlagenhaft

Date Prepared

April 15, 2004

#### Device Name

Trade Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Classification Name: Medical linear accelerator

### Device Description

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

### Substantial Equivalence

The CyberKnife System with the Skeletal Structure Tracking algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

Ms. Anne Schlagenhaft Sr. Regulatory Affairs Associate Accuray, Inc. 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K041315 Trade/Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: May 14, 2004 Received: May 17, 2004

Dear Ms. Schlagenhaft:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becaller of the device is substantially equivalent (for the indications Ferenced as re and no no sure) to legally marketed predicate devices marketed in interstate for use stared in the encreative) to togals. John Medical Device Amendments, or to econimores 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). and Cosmotion (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I va may, therefere, marris of the Act include requirements for annual registration, listing of general controls provisions 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 thay be subject to satin additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I DX has made a ceternmanulations administered by other Federal agencies. You must comply or any I cocar statures and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Ace I requirements and in good manufacturing practice requirements as set forth in the our); faboning (21 CFR Part 820); and if applicable, the electronic product quality Systems (QS) issues (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegh manceang your device of your device to a legally premarket notheation: "The PDF intrally stimally 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 If you desire specific arvice for your 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 Additionally, for questions on into property of the regulation entitled, "Misbranding Other of Comphanos at (201) example (21CFR Part 807.97) you may obtain. Other general by recrence to premation notified.com (er the Act may be obtained from the Division of Small mormation on your responser Assistance at its toll-free number [phone] or Mandrarerors, 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

Page 2

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

510(k) Number (if known): K_0-413 12

Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy

Indications For Use:

The CyberKnife System is indicated for treatment planning and image guided The Cybertifies Bystein is marecision radiotherapy for lesions, tumors and stereofactic radiobargery and pody when radiation treatment is indicated.

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

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)

David De Sygnm

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