ARIA RADIATION ONCOLOGY WITH MIRS

K093527 · Varian Medical Systems, Inc. · IYE · Dec 15, 2009 · Radiology

Device Facts

• Record ID: K093527
• Device Name: ARIA RADIATION ONCOLOGY WITH MIRS
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

Device Story

ARIA Radiation Oncology is a client-server software application for radiation oncology departments. It manages diagnostic images, treatment plans, simulation data, and treatment history. The MIRS (Multimodality Image Registration and Segmentation) component enables multimodality image review, rigid and deformable image registration, structure segmentation, and structure propagation. Radiation therapy staff use the system to prepare, approve, and verify treatment plans and track delivered doses. The system centralizes data in a common database shared with other Varian software (e.g., Eclipse, Acuity). By facilitating image guidance and adaptive planning, the device assists clinicians in clinical decision-making regarding treatment delivery and quality assurance, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and verification/validation of software functionality.

Technological Characteristics

Client-server software architecture; common database for data storage and retrieval. Features include multimodality image review, rigid and deformable image registration, structure segmentation, and structure propagation. Operates on standard clinical workstations.

Indications for Use

Indicated for radiation therapy staff to manage treatment plans, diagnostic images, and treatment history data for patients undergoing radiation therapy. Prescription use only.

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

• Vision (with Off-Line Review) (K062391)
• VelocityAIS (VelocityAI) (K081076)
• IKOEngelo (K083591)

Submission Summary (Full Text)

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K093527

# Premarket Notification [510(k)] Summary ARIA Radiation Oncology

The following information is provided following the format of 21 CFR 807.92.

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way e-110<br>Palo Alto, CA 94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Date summary was prepared:02 November 2009 |
| Proprietary Name: | ARIA Radiation Oncology |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: IYE, KPQ |
| Common/Usual Name: | Image Database |
| Predicate Devices: | Vision (with Off-Line Review), K062391<br>VelocityAIS (VelocityAI), K081076<br>IKOEngelo, K083591 |
| Device Description: | ARIA Radiation Oncology is a treatment plan and image management<br>application. It enables the authorized user to enter, access, modify,<br>store and archive treatment plan and image data from diagnostic<br>studies, treatments planning, simulation, and plan verification and<br>treatment. ARIA Radiation Oncology also stores the treatment histories<br>including dose delivered to defined sites, and provides tools to verify<br>performed treatments. ARIA Radiation Oncology is designed to assist<br>the radiation therapy staff to prepare and approve treatment plans, and<br>to perform quality assurance of the treatments, i.e., to follow-up the<br>delivered treatments and dose to defined sites. The preparation tasks<br>include image acquisition, viewing and manipulation, treatment plan<br>definition, manipulation and scheduling. |
| | ARIA Radiation Oncology (K042956) has been modified to introduce a<br>new component called MIRS (Multimodality Image Registration and<br>Segmentation). MIRS provides components to perform various types of<br>image registration and segmentation to facilitate and support the<br>clinical goals of image guidance and adaptation including:<br>multimodality image review capabilities, deformable and rigid<br>multimodality image, structure segmentation and approval and<br>structure propagation between registered images. |
| | ARIA Radiation Oncology is based on the client-server architecture, and<br>thus all ARIA Radiation Oncology clients/workstations load data from |

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# Premarket Notification [510(k)] Summary ARIA Radiation Oncology

and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision/ARIA).

Statement of Indications for Use: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Technological Characteristics:

Refer to the Substantial Equivalence Comparison Chart in this submission.

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Image /page/2/Picture/0 description: The image shows a logo with text and a symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around a symbol. The symbol is a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white and appears to be from an official government source.

#### 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. Vy Tran Vice President, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

### DEC 1 5 2009

Re: K093527

Trade/Device Name: ARIA Radiation Oncology with MIRS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ i Dated: November 2, 2009 Received: November 16, 2009

Dear Ms. Tran:

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. Ilsting 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); medical device reporting (reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

1

Enclosure

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### Indications for Use

K093527

510(k) Number (if known):

Device Name: ARIA Radiation Oncology with MIRS

Indications for Use:

The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

× Prescription Use (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)

Tony McWhan

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

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