ARIA RADIATION THERAPY MANAGEMENT

K133572 · Varian Medical Systems, Inc. · IYE · Apr 4, 2014 · Radiology

Device Facts

• Record ID: K133572
• Device Name: ARIA RADIATION THERAPY MANAGEMENT
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ARIA Radiation Therapy Management 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 Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Device Story

ARIA Radiation Therapy Management is a software application for radiation oncology departments; manages treatment plans, diagnostic images, and treatment history. Inputs include diagnostic studies, treatment planning data, simulation data, and verification data; supports DICOM import, film digitizers, and network-based data transfer. System centralizes data storage, archiving, and restoration. Features include rigid registration for patient positioning, n-point matching, off-line review detection, and portal dosimetry gamma evaluation. Clinicians use the system to visualize, process, and manipulate data to verify performed treatments and track delivered doses. Output assists healthcare providers in clinical decision-making regarding radiation therapy delivery; benefits patients by ensuring accurate treatment plan management and verification of delivered radiation doses.

Clinical Evidence

No clinical data. Performance was established through verification and validation testing of software requirements and hazard safeguards.

Technological Characteristics

Software-based treatment plan and image management application. Connectivity via DICOM and network import. Conforms to IEC 61217:2008, IEC 62366:2007, and IEC 62304 1st Ed. Features include rigid registration, n-point matching, and portal dosimetry gamma evaluation.

Indications for Use

Indicated for use by authorized clinicians to manage treatment plans, diagnostic images, and treatment history data for patients undergoing radiation therapy, including simulation, planning, verification, and dose delivery tracking.

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

• ARIA Radiation Oncology (K093527)

Submission Summary (Full Text)

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## APR 0 4 2014

K133572
Page 1 of 2

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

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

Submitter's Name:

Varian Medical Systems, Inc. 3120 Hansen Way C-260 Palo Alto, CA 94304

Contact Name: Peter J. Coronado Phone: [phone] Fax: [phone] Date: November 2013

ARIA Radiation Therapy Management

ARIA Radiation Therapy Management

ARIA Radiation Oncology: K093527

Trade Name:

Common Name:

Classification Name:

Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: IYE

Predicate Device:

Device Description:

The ARIA Radiation Therapy Management 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 Therapy Management also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.

ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through the network using DICOM, the available image import filters or by means of film digitizers.

Intended Use Statement

The ARIA Radiation Therapy Management 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 Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Indications for Use Statement

The ARIA Radiation Therapy Management 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 Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify

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K133572
page 2 of 2

### performed treatments.

Technological Characteristics: Changes to the predicate device are listed below.

- Device name change ●
- Removal of the MIRS features
- Re-structure and re-naming single software device feature into five features
- . Improved rigid registration for patient position and n-point matching
- Third party compatibility .
- . Improved DICOM user interface
- Improved Off-Line Review detection and match ●
- Enhanced Portal Dosimetry gamma evaluation .
- Improved workflow usability .

Summary of performance Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly.

Standards conformance:

ARIA Radiation Therapy Management conforms in whole or in part with the following standards:

IEC 61217:2008

IEC 62366:2007

IEC 62304 1st Ed.

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Public Health Service

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

April 4, 2014

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/4 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings, rendered in a simple, bold line drawing.

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K133572

Trade/Device Name: ARIA Radiation Therapy Management Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 28, 2014 Received: March 12, 2014

#### Dear Mr. Coronado:

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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### Page 2-Mr. Coronado

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K133572

#### Device Name ARIA Radiation Therapy Management

#### Indications for Use (Describe)

The ARIA Radiation Therapy Management 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 diagnosic studies, treatment planning, simulation, plan verification and treament. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Mechal D. O'Hara

FORM FDA 3881 (9/13)

PSC Publishing Sert nees ( KH) i 443-67 80 FJ

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