CyberKnife Treatment Delivery System

K170788 · Accuray Incorportaed · IYE · Apr 11, 2017 · Radiology

Device Facts

• Record ID: K170788
• Device Name: CyberKnife Treatment Delivery System
• Applicant: Accuray Incorportaed
• Product Code: IYE · Radiology
• Decision Date: Apr 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CyberKnife® Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

Device Story

Computer-controlled radiation delivery system for stereotactic radiosurgery and precision radiotherapy. Uses 6 MV linear accelerator mounted on robotic manipulator; target locating subsystem provides X-ray imaging for real-time positioning. Employs multiple tracking modalities: skull, fiducial, skeletal, lung tumor, and Synchrony tracking for dynamic beam pointing. Integrates with Accuray Precision Treatment Planning System and iDMS Data Management System. Used in clinical settings by trained medical professionals. System delivers high-energy radiation to targets; enables minimally invasive treatment of lesions/tumors throughout body. Output allows clinicians to perform precise dose delivery; benefits patients by providing non-surgical alternative for complex tumors/conditions.

Clinical Evidence

Bench testing only. Verification and regression testing performed to confirm hardware and software integrity and performance equivalence to the predicate device.

Technological Characteristics

6 MV linear accelerator; robotic manipulator; target locating subsystem (X-ray imaging); beam-limiting secondary collimators (fixed, variable, and multileaf). Integrates with external treatment planning and data management systems. Software-controlled radiation delivery.

Indications for Use

Indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated. Applicable to various cancers and benign conditions (e.g., astrocytoma, glioma, metastases, AVM, trigeminal neuralgia). Patient candidacy determined by physician team.

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

• CyberKnife M6 Systems (K150873)

Reference Devices

• Accuray Precision Treatment Planning System (K161136)
• iDMS Data Management System (K161144)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them, representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2017

Accuray Incorportaed % Ms. Jyoti Singh Regulatory Affairs Specialist 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K170788

Trade/Device Name: CyberKnife® Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 15, 2017 Received: March 16, 2017

Dear Ms. Singh:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170788

Device Name

CyberKnife® Treatment Delivery System.

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 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 Jyoti Singh

# Date Prepared

March 15, 2017

#### Device Name

Trade Name: CyberKnife® Treatment Delivery System Common Name: Radiosurgery/radiotherapy delivery system Regulation Number: 21 CFR 892.5050 Regulatory Classification Name: Medical charged-particle radiation therapy system Regulatory Class: II Requlatory Product Code: IYE Classification Panel: Radiology

#### Device Description

The CyberKnife® Treatment Delivery System (CKTDS), subject of this submission, is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision™ Treatment Planning System (K161136) and iDMS™ Data Management System (K161144).

The CKTDS uses a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem of the treatment delivery system provides X-rays of the treatment area that lets the user know the position of the

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target. The CyberKnife® Treatment Delivery System uses skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Tracking for dynamic positioning and pointing of the linear accelerator. The fixed aperture, variable aperture, and multileaf collimators are available as various beam-limiting secondary collimators.

## Indications for Use

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

### Intended Use

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

The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

#### Substantial Equivalence

The CyberKnife® Treatment Delivery System is substantially equivalent to the treatment delivery component of the predicate, CyberKnife M6 Systems (cleared under K150873). The intended use for radiologic applications, principles of operation, technological characteristics are the same as the treatment delivery component of the predicate device.

The source energy, beam properties, design, materials and other physical properties of the subject device are the same or equivalent to the treatment delivery component of the predicate device.

Testing was done to verify that all hardware and software perform as designed. Regressing testing was also performed to verify integrity of the existing features. The results from testing included in the premarket notification demonstrate that subject device performance characteristics are equivalent to the treatment delivery component of the predicate device.