(57 days)
No
The summary describes a system for retrieving, sending, and verifying treatment plan parameters, which are standard functions for radiation therapy control systems. There is no mention of AI, ML, or related concepts like image processing or training/test sets for algorithms.
No
The device, Verification Console, assists the operator of a proton radiation therapy device and primarily handles treatment plan data transfer and verification. It does not directly deliver therapy or perform a therapeutic function on a patient; rather, it supports the operation of a therapeutic device (the proton radiation therapy device).
No
This device is described as assisting the operator of a proton radiation therapy device by retrieving, sending, and verifying treatment plans. It performs a quality assurance and interface role in the treatment workflow, rather than detecting or diagnosing a disease or condition.
Yes
The device description focuses entirely on software functions: retrieving, sending, verifying, and recording data between existing systems (OIS and TCS). There is no mention of any hardware components being part of the Verification Console itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist the operator of a proton radiation therapy device by managing treatment plans, verifying parameters, and recording treatment history. This is directly related to the delivery of a medical treatment, not the examination of specimens derived from the human body.
- Device Description: The description focuses on interfacing with treatment control systems and oncology information systems to manage treatment plans and data. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The description does not mention any activities typical of IVDs, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is centered around the workflow and control of a proton radiation therapy device, which is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Verification Console is designed to assist the operator of a proton radiation therapy device. Verification Console retrieves treatment plans from an oncology information system (OIS) and sends plans to the treatment device's treatment control system (TCS). Verification Console then performs verification of treatment plan parameters against TCS delivery parameters for accuracy prior to beam authorization. and sends the treatment history for recording to the OIS.
Product codes
IYE, LHN
Device Description
Verification Console is designed to perform an interface role to connect to proton therapy control systems. The general function of the Verification Console is to allow treatment plans and images to be retrieved from the Varian Oncology Information System and sent to the device's treatment control system (TCS), planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy, and treatment history to be recorded in the Varian Oncology Information System for use and display throughout ARIA and Eclipse. ARIA and Eclipse are separately cleared devices from Varian Medical System. Verification Console is designed to assist the operator of a proton radiation therapy device. Verification Console retrieves treatment plans from an oncology information system (OIS) and sends plans to the treatment device's treatment control system (TCS). Verification Console then performs verification of treatment plan parameters against TCS delivery parameters for accuracy prior to beam authorization, and sends the treatment history for recording to the OIS:
Mentions image processing
Not Found
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
operator of a proton radiation therapy device
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
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Key Metrics
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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Premarket Notification [510(k)] Summary Verification Console
FEB 2 1 2013
The following information is provided following the format of 21 CFR 807.92.
Submitter's Name:
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304
Contact Name: Peter Coronado Phone: 650/424.6320 Fax: 650/842.5040 Date: December 2012
Proprietary Name:
Classification Name:
Common/Usual Name:
Predicate Devices:
Device Description:
Statement of Intended Use
Verification Console
Medical charged-particle radiation therapy system 21. CFR 892.5050, Class II Product Code: IYE
Verification Console
Varian Treatment (K082416)
Verification Console is designed to perform an interface role to connect to proton therapy control systems.
The general function of the Verification Console is to allow treatment plans and images to be retrieved from the Varian Oncology Information System and sent to the device's treatment control system (TCS), planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy, and treatment history to be recorded in the Varian Oncology Information System for use and display throughout ARIA and Eclipse. ARIA and Eclipse are separately cleared devices from Varian Medical System.
Verification Console is designed to assist the operator of a proton radiation therapy device. Verification Console retrieves treatment plans from an oncology information system (OIS) and sends plans to the treatment device's treatment control system (TCS). Verification Console then performs verification of treatment plan parameters against TCS delivery parameters for accuracy prior to beam authorization, and sends the treatment history for recording to the OIS:
Verification Console's statement of intended use was based on and is substantially equivalent to the intended use statement of Varian Treatment. The differences are minor, not critical to the intended
1
therapeutic use of the device, and do not affect the safety and effectiveness of the device when used as labeled since Verification Console's intended use statement is simply a more detailed account of the language in Varian Treatment's intended use statement.
Technological Characteristics: . Verification Console is substantially equivalent to and has similar technological characteristics as the predicate device (Varian Treatment). The functionality of both devices is equivalent in safety and effectiveness.
The table below provides a comparison of the significant changes between Verification Console and Varian Treatment.
| Verification Console | Predicate - Varian Treatment |
|---|---|
| Supports proton beam delivery | Supports external beam photon delivery |
| Interface to Proton radiation | |
| therapy machine | Interface to non-Varian linac |
| radiotherapy machines |
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Summary of performance testing:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem. The text is in uppercase letters and is intended to convey the department's name and its affiliation with the United States of America.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 21, 2013
Mr. Peter Coronado Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way, m/s E-110 PALO ALTO, CA 94304-1038
Re: K124002
Trade/Device Name: Verification Console Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 21, 2012 Received: December 26, 2012
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.
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
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Page 2 - Mr. Peter Coronado
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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.
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/cdrh/industry/support/index.html.
Sincerely Yours.
Micha FDA Hara
Janine M. Morris, Director Division of Radiological Health Office of In Vitro Diagnostic Devices And Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K124002
Device Name: Verification Console
Indications for Use:
Verification Console is designed to assist the operator of a proton radiation therapy device. Verification Console retrieves treatment plans from an oncology information system (OIS) and sends plans to the treatment device's treatment control system (TCS). Verification Console then performs verification of treatment plan parameters against TCS delivery parameters for accuracy prior to beam authorization. and sends the treatment history for recording to the OIS.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
MichaFDAHara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)_K124002
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