MOTION TRACKING

K020294 · Accuray, Inc. · IYE · Apr 22, 2002 · Radiology

Device Facts

• Record ID: K020294
• Device Name: MOTION TRACKING
• Applicant: Accuray, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

Device Story

Motion Tracking System is an accessory to the CyberKnife System; enables dynamic image-guided stereotactic radiosurgery and radiotherapy for moving targets (e.g., lung, diaphragm). System inputs include patient surface movement (thorax/abdomen) and periodic x-ray images of the target lesion. Device establishes a mathematical correspondence between surface motion and internal target position; updates this model regularly via x-ray imaging. During treatment, system monitors surface movement in real-time to estimate lesion position; commands robot manipulator to compensate for target motion during radiation delivery. Used in clinical settings by trained personnel. Benefits include reduced normal tissue exposure, smaller irradiation margins, shorter treatment times, and increased patient comfort compared to breath-hold techniques.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

System includes sensor assembly, tracking targets, cable junction box, and controller. Operates as an accessory to the CyberKnife System. Provides real-time motion compensation for robotic radiation delivery. Technical specifications and material details are referenced to internal documentation (Tab 9).

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, or conditions exhibiting respiratory-induced motion.

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

• Accuray CyberKnife System (K011024)
• Varian Medical Systems RPM Respiratory Gating System (K983629)

Submission Summary (Full Text)

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# APR 2 2 2002

Korozay

## Tab 4

# Premarket Notification [510(k)] Summary

January 25, 2002

| Trade Name: | Motion Tracking System |
|---------------------------------------------------------|-------------------------------------------------------------------------------|
| Common Name: | Linear Accelerator for Radiation Therapy |
| Classification Name: | Medical Linear Accelerator Accessory, 90 IYE (per 21<br>CFR section 892.5050) |
| Manufacturer's Name:<br>Address: | Accuray Incorporated<br>570 Del Rey Avenue<br>Sunnyvale, CA 94085 |
| Corresponding Official:<br>Title:<br>Telephone:<br>Fax: | Donald E. Caddes<br>President and COO<br>408-522-3740<br>408-522-3749 |

Accuray CyberKnife® System, K011024 and Varian Predicate Devices: Medical Systems RPM Respiratory Gating System, K983629.

Device Description: Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.

During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.

Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for

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the treatment target motion within the body, in real-time, while the radiation is being delivered.

The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.

Intended Use: The Motion Tracking System is an option to the CyberKnife System and is intended to enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

Technological Characteristics: Refer to Tab 9.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Donald E. Caddes President and COO Accuray Incorporated 570 Del Rey Avenue SUNNYVALE CA 94085 Re: K020294

Trade/Device Name: Motion Tracking System Respiratory Tracking Accessory Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation system

Regulatory Class: II Product Code: 90 IYE Dated: January 25, 2002 Received: January 28, 2002

Dear Mr. Caddes:

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 (PMA), it may be subject to 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,

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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 nothleate 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 If you desire specific across at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

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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Accuray Motion Tracking System Traditional 510(k)

# Tab 3

# Indications For Use

510(k) Number: *K020294*

Device Name: Motion Tracking System

## Indications for Use:

To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

## (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use_

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdomis and Radiological Devices 510(k) Numbe

OR