The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

Device Description

4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (OIS) and send the plan and images to the Treatment Console System (TCS). The planned treatment parameters from the OIS are verified against the TCS delivery parameters for accuracy. All treatment parameters on the TCS must match the treatment parameters on the 4DITC before treatment can be delivered. After the treatment has been completed for the session, the user closes the session and treatment history is sent to the OIS to be recorded. The recorded treatment history can then be displayed and reviewed in the Oll.

AI/ML Overview

This document describes the 510(k) summary for Varian Medical Systems, Inc.'s 4D Integrated Treatment Console v13.0 MR4. However, the provided text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on explaining the device's function, comparing it to a predicate device (v13.0), and listing software changes. It mentions "Software Verification and Validation Testing" and "Test results demonstrate conformance to applicable requirements and specifications" but does not provide any quantitative performance data, specific acceptance criteria, or details of a study with a test set, ground truth, or expert involvement.

Therefore, I can only address parts of your request based on the information not present in the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study

The provided text does not include a table of acceptance criteria or reported device performance metrics in a quantitative manner. It states that "Test results demonstrate conformance to applicable requirements and specifications" and that the device "should perform as intended," but no specific numerical targets or results are given.

Missing Information & Assumptions Based on Typical Device Submissions (Not from provided text):

Given the nature of this device (a software-controlled system for radiation therapy treatment delivery), performance testing would typically involve:

Functional Testing: Verifying that the software correctly manages and displays treatment parameters, prevents irradiation when parameters are out of conformance, handles data transfer, etc.
Accuracy/Precision Testing: Confirming that the system accurately verifies parameters against the treatment plan. This might involve simulated scenarios or phantoms.
Safety Testing: Demonstrating that the risk control measures (like blocking QA plans for clinical treatment) function as intended to prevent patient harm.
Cybersecurity Testing: As mentioned, enhancements were made, so testing would confirm the effectiveness of these measures.

Here's a breakdown of the specific points you requested, indicating what's present and what's missing:

1. A table of acceptance criteria and the reported device performance

Missing: The document states "Test results demonstrate conformance to applicable requirements and specifications" but provides no specific table, quantitative acceptance criteria, or performance data.

2. Sample sized used for the test set and the data provenance

Missing: No information on sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set is provided. The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This strongly suggests the testing was predominantly non-clinical (software verification and validation, perhaps hardware-in-the-loop testing, but not involving human patient data in a "study" sense).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing: No ground truth establishment method involving experts is described, as there's no mention of a clinical or data-driven study that would require such a ground truth.

4. Adjudication method for the test set

Missing: Not applicable, as no multi-expert ground truth establishment or test set adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing: No MRMC study was done, nor is there any mention of AI assistance for human readers. This device is described as assisting "accurate treatment delivery by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan." It's a control and verification system, not an AI-assisted diagnostic or interpretation tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing: While the device's core function is software-driven ("algorithm only" in that sense), the document doesn't detail performance metrics for this standalone function. It implies the entire system (software and hardware interaction) was verified, but not in a way that provides isolated algorithm performance data. The device's purpose is inherently "human-in-the-loop" as it assists users in treatment delivery and prevents errors.

7. The type of ground truth used

Missing in detail: Given the nature of a radiation therapy control system, "ground truth" would likely be established by:
- Specification Compliance: Confirming that system outputs match predefined engineering specifications and design documents.
- Expected System Behavior: Verifying that the system behaves as expected under various input conditions (e.g., correctly identifies out-of-conformance parameters, accurately blocks treatment when conditions are not met).
- Manual Verification/Simulation: Using phantoms or simulated data to ensure the system's parameter monitoring and interlock functions are accurate.
Not explicitly stated: The document does not specify "expert consensus," "pathology," or "outcomes data" as ground truth, as those typically apply to diagnostic or prognostic AI/image analysis systems, which this device is not.

8. The sample size for the training set

Missing: Not applicable. This device is a software control system; it's not described as using machine learning that would require a "training set" in the typical sense for a predictive model or image analysis algorithm. The V&V testing is for verifying the correctness and robustness of its programmed logic and functions.

9. How the ground truth for the training set was established

Missing: Not applicable, as there's no mention of a training set or machine learning components.

Summary:

The provided K203766 FDA 510(k) summary for Varian's 4D Integrated Treatment Console v13.0 MR4 details software changes and asserts that "Software verification and validation were conducted," and "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide the specific quantitative performance data, acceptance criteria, study methodologies (e.g., sample sizes, ground truth establishment, expert involvement), or clinical study details that your request asks for. This is common for 510(k) submissions of iterative software updates to established predicate devices, where the focus is typically on non-clinical V&V demonstrating that the changes do not adversely affect safety or effectiveness and that the updated device performs as intended in alignment with its predicate.

Summary

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February 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Senior Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K203766

Trade/Device Name: 4D Integrated Treatment Console v13.0 MR4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: December 22, 2020 Received: December 23, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203766

Device Name 4D Integrated Treatment Console v13.0 MR4

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com

510(k) Summary

The following information is provided as required by 21 CFR 807.92		K203766
SUBMITTER
Name and Address:	Varian Medical Systems, Inc.3100 Hansen Way, m/s E110Palo Alto, CA 94304
Contact Person:	Peter J. CoronadoSenior Director of Regulatory AffairsPhone: 650-424-6320 Fax: 650-646-9200submissions.support@varian.com
Date Prepared:	December 22, 2020
DEVICE
Subject Device Name:	4D Integrated Treatment Console v13.0 MR4
Common/Usual Name:	4D Integrated Treatment Console
Product Code and Classification:	Medical charged-particle radiation therapy systemMUJ 21 CFR 892.5050 Class II
PREDICATE DEVICE
Predicate Device Name:Reference Device(s):	4D Integrated Treatment Console v13.0 (K133331)No reference devices were used in this submission

DEVICE DESCRIPTION

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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com

INDICATIONS FOR USE

The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modified device, referred to as the "subject device" throughout this summary, is release version v13.0 MR4 (Version 13.0 Minor Release 4) of the 4D Integrated Treatment Console with additional software changes incorporated since the release version of the predicate device, v13.0 (version 13.0; K133331).

The Changes in the subject device compared with the predicate device are as follows:

Risk control measure of accidentally treating with a Quality Assurance (QA) / verification . plan changed from a warning message to blocking the use of QA / verification plans for treatment in clinical mode
Shared Framework Integration ●
Microsoft Windows Embedded Standard (WES) 7 Support ●
IGMA 8913 workstation updated to IGMA 8110D ●
Cybersecurity Enhancements ●
- WES7 Knowledge Base (KB) updates O
- o Application whitelisting (Applocker)
- USB mass storage hardening O
- MICAP firmware upgrade o
Minor enhancements and bug fixes ●

PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

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Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this pre-market submission.

Standards Conformance

The subject device conforms in whole or in part with the following standards:

IEC 62304:2006+A1:2015 Medical device software - Software lifecycle processes
IEC 62366-1:2015 Medical device – Part 1: Application of usability engineering to medical devices
IEC 61217:2011 Radiotherapy Equipment Coordinates, Movements and Scales .
IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems

CONCLUSION

The predicate device was cleared based only on non-clinical testing, and no animal or clinical studies were performed for the subject device. The non-clinical verification and validation data demonstrates that the subject device should perform as intended in the specified use conditions.

Therefore, Varian considers the subject device, 4D Integrated Treatment Console v13.0 MR4, is substantially equivalent to the predicate device 4D Integrated Treatment Console v13.0 (K133331).

Regulation Number and Section

§ 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.