(135 days)
Not Found
No
The description focuses on data management, storage, and visualization, with no mention of AI or ML algorithms for analysis or decision support.
No
The device is described as a treatment plan and image management application, which supports the workflow of radiation therapy but does not directly deliver therapy or perform a therapeutic action itself. It stores and manages data related to treatment but is not a therapeutic device.
No
The device is described as a "treatment plan and image management application" that stores and manages data from diagnostic studies, but it does not perform the diagnostic studies itself. Its primary function is related to treatment planning and management.
Yes
The device description explicitly states it is a "treatment plan and image management application" and describes its functions as enabling users to "enter, access, modify, store and archive treatment plan and image data." It also mentions supporting "integration of all data and images in one central database" and providing "tools to verify performed treatments." These descriptions focus on software functionalities related to data management, processing, and visualization, without mentioning any specific hardware components that are part of the device itself. While it interacts with images from various sources (diagnostic studies, treatment planning, etc.) and potentially hardware like film digitizers, the device itself is presented as the software application managing this data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is for "treatment plan and image management application" in the context of "Radiation Therapy Management." It focuses on managing data and images related to radiation treatment, not on analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The description reinforces its function as a data and image management system for radiation therapy. It handles images from various stages of the radiation treatment process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is centered around managing data and images for radiation therapy planning and delivery, which is a treatment process, not an in vitro diagnostic process.
N/A
Intended Use / Indications for 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.
Product codes
IYE
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized user
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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: 650.424.5731 Fax: 650.842.5040 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
1
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.
2
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.
3
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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
5
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