VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM

K102915 · Viewray, Incorporated · MUJ · Jan 12, 2011 · Radiology

Device Facts

• Record ID: K102915
• Device Name: VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
• Applicant: Viewray, Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Jan 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ViewRay™ Treatment Planning and Delivery System is intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the System, an MRI image-guided radiation therapy system.

Device Story

ViewRay TPDS is a computer-based system for planning and delivering external gamma beam stereotactic radiosurgery and precision radiotherapy. It integrates with an MRI image-guided radiation therapy system. Clinicians use the software to review, prescribe, track, and correct patient treatment. Key functions include contouring, visualization, data storage, anatomical target monitoring, and reoptimization. The system assists in managing radiation treatment for lesions, tumors, and conditions throughout the body. It is operated by trained medical professionals in a clinical setting.

Clinical Evidence

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

Technological Characteristics

Computer-based radiation therapy planning and delivery system. Designed to conform to IEC 60601-1, IEC 60601-2-11, IEC 62083, and IEC 61217. Integrates with MRI image-guided radiation therapy hardware. Software-based tools for contouring, visualization, and reoptimization.

Indications for Use

Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when 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.

Predicate Devices

• Varian Medical Systems' Trilogy Mx™ System (K092871)
• Eclipse™ Treatment Planning System (K091492)

Submission Summary (Full Text)

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# K102915

JAN 1 2 2011

## 510(k) Summary as required by section 807.92(c)

Submitter's name: ViewRay Incorporated 2 Thermo Fisher Way Oakwood, Ohio 44146 440-703-3210 Fax [phone]

Contact person: Janice Brownlee

Date prepared: September 30, 2010

Trade Name of Device: ViewRay™ Treatment Planning and Delivery System

Common name: Radiation Therapy Treatment Planning and Delivery System

Classification name: Radionuclide Radiation System (21CFR 892.5750, Product Code IWB)

Predicate Device: Varian Medical Systems' Trilogy Mx™ System K092871 and Eclipse™ Treatment Planning System K091492

Description: The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization.

The software described in this submission has been designed to conform with applicable ections of IEC 60601-1, IEC 60601-2-11, IEC 62083 and IEC 61217.

intended use: The ViewRay™ Treatment Planning and Delivery System is intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the System, an MRI image-guided radiation therapy system. /iewRay™

CONFIDENTIAL ViewRay Page 17 J

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Technological Characteristics compared to predicate device: The ViewRay™Treatment Planning and Delivery System shares many of the technological features and characteristics of the Varian Eclipse planning system, and the treatment delivery features of the Varian Trilogy System. The fundamental technical characteristics are the same as those of the predicate devices and minor differences are described in the comparison chart and discussion provided elsewhere in this 510(k) submission.

Conclusion: The ViewRay™ Treatment Planning and Delivery System has the same intended use, indications for use and user population as the Varian Eclipse™/Trilogy Mx™ System. The ViewRay™ Treatment Planning and Delivery System has most of the features and technological characteristics as the predicate devices, and the few distinguishing characteristics do not raise new types of safety or effectiveness issues.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Janice Brownlee VP, Regulatory Affairs and Quality Assurance ViewRay Incorporated 2 ThermoFisher Way OAKWOOD VILLAGE OH 44146

JAN 1 2 200

Re: K102915

Trade/Device Name: ViewRay™ Treatment Planning and Delivery System Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: September 20, 2010 Received: November 1, 2010

Dear Ms. Brownlee:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 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,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 1C. Regulatory Sections

#### Indications for Use

JAN 1 2 2011

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ViewRay™ Treatment Planning and Delivery System

Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Division of Radiologi Office of In Vitro Diagnostic Device Evalu

510K K102915

CONFIDENTIAL ViewRay Page 16