(29 days)
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.
ARIA Radiation Oncology 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, treatments planning, simulation, and 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 Radiation Oncology is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.
ARIA Radiation Oncology (K042956) has been modified to introduce a new component called MIRS (Multimodality Image Registration and Segmentation). MIRS provides components to perform various types of image registration and segmentation to facilitate and support the clinical goals of image guidance and adaptation including: multimodality image review capabilities, deformable and rigid multimodality image, structure segmentation and approval and structure propagation between registered images.
ARIA Radiation Oncology is based on the client-server architecture, and thus all ARIA Radiation Oncology clients/workstations load data from 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).
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the ARIA Radiation Oncology device with the MIRS component.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria. While it mentions MIRS (Multimodality Image Registration and Segmentation) provides capabilities for image registration and segmentation, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number or qualifications of experts, or adjudication method for a test set.
- Information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Details on standalone (algorithm only) performance.
- The type of ground truth used in any studies.
- Sample size or how ground truth was established for a training set.
The summary primarily states the purpose of the MIRS component and its functionalities (image review, deformable and rigid registration, structure segmentation and approval, structure propagation), but not the quantitative performance metrics or the studies conducted to validate these.
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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.3100 Hansen Way e-110Palo Alto, CA 94304 |
|---|---|
| Contact Name: Vy TranPhone: 650/424.5731Fax: 650/842.5040E-mail: vy.tran@varian.comDate summary was prepared:02 November 2009 | |
| Proprietary Name: | ARIA Radiation Oncology |
| Classification Name: | Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: IYE, KPQ |
| Common/Usual Name: | Image Database |
| Predicate Devices: | Vision (with Off-Line Review), K062391VelocityAIS (VelocityAI), K081076IKOEngelo, K083591 |
| Device Description: | ARIA Radiation Oncology is a treatment plan and image managementapplication. It enables the authorized user to enter, access, modify,store and archive treatment plan and image data from diagnosticstudies, treatments planning, simulation, and plan verification andtreatment. ARIA Radiation Oncology also stores the treatment historiesincluding dose delivered to defined sites, and provides tools to verifyperformed treatments. ARIA Radiation Oncology is designed to assistthe radiation therapy staff to prepare and approve treatment plans, andto perform quality assurance of the treatments, i.e., to follow-up thedelivered treatments and dose to defined sites. The preparation tasksinclude image acquisition, viewing and manipulation, treatment plandefinition, manipulation and scheduling. |
| ARIA Radiation Oncology (K042956) has been modified to introduce anew component called MIRS (Multimodality Image Registration andSegmentation). MIRS provides components to perform various types ofimage registration and segmentation to facilitate and support theclinical goals of image guidance and adaptation including:multimodality image review capabilities, deformable and rigidmultimodality image, structure segmentation and approval andstructure propagation between registered images. | |
| ARIA Radiation Oncology is based on the client-server architecture, andthus 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 (800) 638-2041 or (301) 796-7100 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
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
$\sim$
§ 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.