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.

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.

AI/ML Overview

The provided text describes a "Verification Console" device, but it lacks detailed information about acceptance criteria, a specific study proving device performance against those criteria, or most of the other requested elements for summarizing a device study. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics.

Based on the available information:

Table of acceptance criteria and reported device performance: This information is not provided in the document. The document states "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly," but it doesn't list the specific requirements, their acceptance criteria, or quantitative performance results.
Sample size used for the test set and the data provenance: Not specified. The document mentions "verification and validation testing" in a general sense but does not detail a test set, its size, or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. Given the device's function (interfacing between systems and verifying parameters), "ground truth" in the traditional sense of medical image interpretation by experts is not directly relevant. There's no mention of experts establishing a ground truth for any test set.
Adjudication method: Not applicable or specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: No, an MRMC study was not done. The device is not an AI/CAD device for diagnostic interpretation; therefore, an MRMC study to assess human reader improvement with AI assistance is not relevant to this device's function.
Standalone performance study (algorithm only without human-in-the-loop performance): The document doesn't detail a standalone performance study with specific metrics. The device's function (verification of treatment plan parameters against delivery parameters) is inherently a "human-in-the-loop" assistance tool, not a standalone diagnostic algorithm. The summary broadly states that the "functionality of both devices is equivalent in safety and effectiveness," referring to the predicate device.
Type of ground truth used: Not explicitly stated or applicable in the traditional sense. For a device that verifies treatment plan parameters against delivery parameters, the "ground truth" would likely be the actual, correct delivery parameters and system states, which are intrinsically digital and rule-based, rather than subjective expert interpretations or pathology. The document doesn't elaborate on how this "ground truth" was established for testing.
Sample size for the training set: Not applicable or specified. The device is not described as an AI/machine learning model that undergoes a training phase.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

Summary of what is available regarding verification and validation:

The document states: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."

This general statement indicates that Varian Medical Systems, Inc. performed internal testing to ensure the "Verification Console" met its design requirements and safety standards. However, the specific protocols, metrics, sample sizes, and detailed outcomes of these tests are not provided in this 510(k) summary. The summary's focus is on establishing substantial equivalence to the predicate "Varian Treatment" device, primarily through comparing their intended use and technological characteristics (e.g., supporting proton vs. photon delivery, interface type).

Summary

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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'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

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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 radiationtherapy machine	Interface to non-Varian linacradiotherapy 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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Regulation Number and Section

N/A