CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM

K051941 · Accuray, Inc. · MUJ · Aug 9, 2005 · Radiology

Device Facts

• Record ID: K051941
• Device Name: CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
• Applicant: Accuray, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 9, 2005
• 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. Inputs include medical images for treatment planning and real-time target tracking data. The system integrates a linear accelerator mounted on a robotic manipulator with a target-locating subsystem. It delivers radiation to lesions, tumors, or conditions anywhere in the body. Operated by clinicians in a clinical setting, the system uses image guidance to adjust radiation delivery based on patient or target movement. Output consists of precise radiation beams. This allows for minimally invasive treatment, potentially improving patient outcomes by sparing healthy tissue while targeting pathology.

Technological Characteristics

System comprises a linear accelerator, robotic manipulator, and image-guided target locating subsystem. Operates as a computer-controlled medical charged-particle radiation therapy system (21 CFR 892.5050).

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 treatment is 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}------------------------------------------------

K051941

## AUG 9 - 2005 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

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

#### Contact Person

Anne Schlagenhaft

#### Date Prepared

July 15, 2005

#### Device Name

Trade Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Classification Name: Medical charged-particle radiation therapy system

### 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 anywhere in the body.

#### 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, turnors and conditions anywhere in the body when radiation treatment is indicated.

### Substantial Equivalence

The CyberKnife System with the subject modifications is substantially equivalent to the predicate devices. The intended use, principles of operation, and technological characteristics are the same.

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

Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three lines forming its head, body, and tail, giving it a modern and abstract appearance.

AUG 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

#### · Re: K051941

Robert +1
Trade/Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ

Dated: July 15, 2005 Received: July 19, 2005

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 do inc. require 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.

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.

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

This letter will allow you to begin marketing your device as described in your Section 5 0 (k) This letter will anow you to begin hancing your article of your device of your device to a legally premarket notification. The IDA inding of substantial of a loce 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 advice for your device of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation childer, "risonation on your responsibilities under the Act from the 190 807.97). You may obtain other general mormation on your september 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 C. hogdon

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

Enclosure

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

510(k) Number (if known): K_O5-194 (

Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy

Indications For Use:

The CyberKnife System is indicated for treatment planning and image-guided The CyberKillite Bystein is mercecision radiotherapy for lesions, tumors and stereotactic radiosurgery and processon and ation treatment is indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use

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

ت ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Optional Format 1-2-96)

David A. Johnson
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _