(29 days)
No
The summary describes image registration and segmentation, which are image processing techniques. However, it does not mention AI, ML, deep learning, or any related terms or concepts that would indicate the use of AI/ML technology. The description of the new MIRS component focuses on image registration and segmentation without specifying the underlying algorithms as AI/ML-based.
No
The device is a treatment plan and image management application used by radiation therapy staff to prepare and approve treatment plans and perform quality assurance. It does not directly provide therapy to a patient.
No
The device is described as a treatment plan and image management application used for radiation oncology. While it handles data from "diagnostic studies," its primary function is for treatment planning, verification, and management, not for making a diagnosis itself. It assists in preparing and approving treatment plans and performing quality assurance of treatments.
Yes
The device is described as a "treatment plan and image management application" and "software product". While it interacts with other systems and data, the description focuses solely on the software's functions and architecture (client-server) without mentioning any specific hardware components included as part of the device itself. The modifications also describe new software components (MIRS).
Based on the provided text, the ARIA Radiation Oncology product 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.
- ARIA's Function: ARIA Radiation Oncology is described as a "treatment plan and image management application." Its primary functions involve managing and processing medical images (from diagnostic studies, simulation, etc.) and treatment plan data for radiation therapy. It assists in planning, verifying, and tracking radiation treatments.
- No mention of biological samples: The description does not mention the analysis of any biological samples from the patient. Its focus is on image and treatment data.
Therefore, ARIA Radiation Oncology falls under the category of medical image management and treatment planning software, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE, KPQ, MUJ
Device Description
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).
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
radiation therapy staff
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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-110
Palo Alto, CA 94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran
Phone: 650/424.5731
Fax: 650/842.5040
E-mail: vy.tran@varian.com
Date summary was prepared:02 November 2009 |
| Proprietary Name: | ARIA Radiation Oncology |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE, KPQ |
| Common/Usual Name: | Image Database |
| Predicate Devices: | Vision (with Off-Line Review), K062391
VelocityAIS (VelocityAI), K081076
IKOEngelo, K083591 |
| Device Description: | 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 |
:
1
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.
2
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
3
Page 2 -
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
4
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
$\sim$