(135 days)
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.
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.
After reviewing the provided FDA 510(k) summary for "ARIA Radiation Therapy Management," it appears that the document describes a software application for managing radiation therapy data and images, rather than an AI-powered diagnostic or assistive device that would typically undergo rigorous performance studies with specific acceptance criteria, test sets, and ground truth establishment involving expert readers.
The provided text focuses on:
- Device Description and Intended Use: Managing, storing, accessing, and modifying treatment plan and image data, and storing treatment histories.
- Changes to Predicate Device: Listing minor software feature changes, such as improved rigid registration, DICOM UI, and workflow usability.
- Summary of Performance: A generic statement that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly."
- Standards Conformance: Listing relevant IEC standards (e.g., IEC 61217, IEC 62366, IEC 62304).
Crucially, there is no mention of:
- Specific acceptance criteria tied to a particular performance metric (e.g., sensitivity, specificity, accuracy).
- A test set size, data provenance, or details of a study involving human readers or AI performance evaluation.
- Ground truth establishment methods, expert qualifications, or adjudication.
- MRMC studies or standalone algorithm performance.
It seems this device falls under a category where conformance to software engineering standards, functionality testing, and verification/validation against specifications are the primary means of demonstrating safety and effectiveness, rather than a clinical performance study with statistical endpoints. The changes are primarily software enhancements and re-structuring, not the introduction of a new AI algorithm for detection, diagnosis, or prediction that would require such studies.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies in the format you've outlined because the provided document does not contain that level of detail for this specific type of device and its claimed modifications.
To answer your request based only on the provided text, the response would be:
Based on the provided FDA 510(k) summary for ARIA Radiation Therapy Management (K133572), the device is a treatment plan and image management application, and the submission primarily addresses software modifications and functional capabilities, not a new AI-powered diagnostic or assistive feature that would necessitate a clinical performance study with specific acceptance criteria measured against a defined test set.
Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present within this document.
The document broadly states:
- A table of acceptance criteria and the reported device performance: This information is not provided in a quantifiable table format. The summary states: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly." This implies the acceptance criteria were likely functional and performance specifications related to data management, accessibility, storage, and processing, rather than clinical efficacy metrics.
- Sample sized used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as ground truth in the context of clinical interpretation/diagnosis is not relevant for this device's modifications.
- Adjudication method for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not specified. It is highly unlikely for this type of software management system.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified.
- The type of ground truth used: Not specified, given the device's function.
- The sample size for the training set: Not specified. (This device is not described as involving machine learning training.)
- How the ground truth for the training set was established: Not applicable, as no machine learning training is described.
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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
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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 (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
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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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§ 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.