(30 days)
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No
The summary describes a data management and visualization system for radiation therapy, focusing on storage, access, and verification of treatment plans and images. There is no mention of AI, ML, or any related technologies in the provided text.
No
The device is described as a treatment plan and image management application, which stores and manages data related to radiation therapy, rather than directly treating a condition.
No
The device is described as a treatment plan and image management application, and its primary function is to store and manage data related to treatment, not to diagnose medical conditions.
Yes
The device description explicitly states it is a "treatment plan and image management application" and describes its functions as software-based operations (entering, accessing, modifying, storing, archiving, visualizing, processing, manipulating, managing data and images). There is no mention of accompanying hardware components that are part of the medical device itself. The performance studies focus on software verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ARIA Radiation Therapy Management product is described as a "treatment plan and image management application." Its primary functions are:
- Entering, accessing, modifying, storing, and archiving treatment plan and image data.
- Storing treatment histories and dose delivered.
- Providing tools to verify performed treatments.
- Integrating data and images in a central database.
- Visualizing, processing, manipulating, and managing data and images.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the human body. The focus is entirely on managing and processing data and images related to radiation therapy planning and treatment.
Therefore, the ARIA Radiation Therapy Management product falls under the category of medical device software used for managing and supporting radiation therapy, not for performing diagnostic tests on biological samples.
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
The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized user
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
No clinical tests have been included in this pre-market submission.
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the device performs as intended. Varian therefore considers ARIA Radiation Therapy Management 15.5 MR1 to be safe and effective and to perform at least as well as the predicate device.
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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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Wav Palo Alto CA 94304
January 17, 2018
Re: K173838
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: December 15, 2017 Received: December 18, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara 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)
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 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.
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)
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Premarket Notification [510(k)] Summary
ARIA Radiation Therapy Management 15.5 MR1
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian
3100 Hansen Way E-110
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
Date: December 15, 2017 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | ARIA Radiation Therapy Management |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual Name: | ARIA Radiation Therapy Management |
| Predicate Devices: | ARIA Radiation Therapy Management (K133572) |
| 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 performed treatments. |
Technological Characteristics: Changes to the predicate device are listed below:
- Support for Brachy Manual Treatment .
- Shared framework integration ●
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- Support for multi-fractionation is removed
- . Support for Siemens mArc, Hyperarc plans, and proton treatment machines
- . Secondary Channel Integrity Check version 3 support
- . Visualization of MLC outlines was updated to add support for a new stacked MLC
- . Compatibility with SmartIMRT in Eclipse
- Addition of features previously available in ARIA Oncology Information Service; DICOM Worklist, Multi-Vendor DICOM Service, Queue, Varian Exchange.
Summary of Performance Data:
Software Verification and Validation Testing
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Standards conformance: ARIA Radiation Therapy Management conforms in whole or in part with the following
standards IEC 61217:2011-12 IEC 62366: 2007/(R)2013 IEC 62366-2:2015 IEC 62304:2006 DICOM
Clinical Tests No clinical tests have been included in this pre-market submission.
Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the device performs as intended. Varian therefore considers ARIA Radiation Therapy Management 15.5 MR1 to be safe and effective and to perform at least as well as the predicate device.