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

The 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 OIS.

AI/ML Overview

The provided submission does not contain specific acceptance criteria with quantifiable metrics or a detailed study proving the device meets these criteria in the typical sense of a clinical trial for diagnostic or predictive AI. This 510(k) summary is for a Varian Medical Systems' 4D Integrated Treatment Console (4DITC) and focuses on changes and equivalence to a predicate device. The "study" described is verification and validation testing, which is a standard engineering and software testing process to ensure that a device performs as designed and meets its specified requirements.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria with quantifiable performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) and corresponding reported performance values for these criteria.

Instead, the "acceptance criteria" are implied by the statement: "Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements." The "reported device performance" is summarized as: "Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device."

The focus of this submission is on demonstrating that the modified 4DITC (v13) is substantially equivalent to the predicate device (v8.8) and that the new features function as intended, not on proving clinical efficacy or diagnostic accuracy through a traditional clinical study with defined performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical cases. The testing appears to be on the device itself (software and hardware integration).

Sample Size: Not applicable in the context of clinical data. The testing was performed on a "production equivalent device."
Data Provenance: Not applicable as no patient data test set is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Since the testing described is primarily for software and system functionality rather than a diagnostic or predictive task requiring expert ground truth in a clinical sense, this information would likely not be relevant to this type of 510(k) submission. "Qualified personnel" performed the validation, but their specific expertise or number for establishing "ground truth" is not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing performance with and without AI assistance. This device is an integrated treatment console, not an AI-driven image analysis or diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "4D Integrated Treatment Console," implying it's an interface and control system for radiation therapy, inherently designed to be used by humans (operators/clinicians) to manage treatment plans and delivery. It's not a standalone algorithm in the sense of an AI performing a task independently. The validation involved a "production equivalent device" under "clinically representative conditions," suggesting human-in-the-loop interaction for its intended use.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI or diagnostic devices (e.g., pathology, outcomes data) is not directly applicable here. For this type of system, "ground truth" refers to the expected behavior and compliance with design specifications and regulatory requirements. Therefore, the "ground truth" for the verification and validation testing would be the design input requirements and predefined functional specifications for the device’s features and operations.

8. The Sample Size for the Training Set

Not applicable. This device is a software and hardware system for managing radiation therapy, not an AI system that undergoes "training" on a dataset in the way a machine learning model would.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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VARÍAN

Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731

www.varian.com

JAN 27 2014

medical systems

4DITC 510(k) Summary as required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, M/S C-255Palo Alto, CA 94304
	Phone: 650.424.5731Fax: 650.842.5040
Contact Name:	Peter J. CoronadoDirector, Regulatory Affairssubmissions.support@varian.com
Date Prepared:	October 28, 2013
Trade Name:	4D Integrated Treatment Console
Common Name:	4DITC
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050Class II, Product Code MUJ
Predicate Device:	Varian Medical Systems, Inc., 4D Integrated TreatmentConsole (K091132)
Device Description:	The 4D Integrated Treatment Console (4DITC) allows theuser to retrieve treatment plans and images from theOncology Information System (IS) and send the plan andimages to the Treatment Console System (TCS). Theplanned treatment parameters from the OIS are verifiedagainst the TCS delivery parameters for accuracy. Alltreatment parameters on the TCS must match the treatmentparameters on the 4DITC before treatment can be delivered.After the treatment has been completed for the session, theuser closes the session and treatment history is sent to theOIS to be recorded. The recorded treatment history can thenbe displayed and reviewed in the OIS.

The 4D Integrated Treatment Console has been modified to support additional treatment tasks and import/export interfaces. The following chart shows the new features as well as two features that have been removed in version 13.

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Varian Medical Systems, Inc. 3100 Hausen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 ww.varian.com

medical systems

VARŽAN

Technological Characteristics: Changes to the predicate devices are listed in the below table:

Features	Predicate Device4DITC (v8.8)K091132	Modified Device4DITC (v 13)
General description	The 4D Integrated TreatmentConsole (4DITC) is designed toallow treatment plans and imagesto be retrieved from the OncologyInformation System (OIS) andsent to the Treatment ConsoleSystem (TCS), planned treatmentplan parameters to be verifiedagainst the TCS deliveryparameters for accuracy andtreatment history to be recordedin the OIS for use and display.	The 4D Integrated TreatmentConsole (4DITC) is designed toallow treatment plans andimages to be retrieved from theOncology Information System(OIS) and sent to the TreatmentConsole System (TCS), plannedtreatment plan parameters to beverified against the TCS delivery.parameters for accuracy andtreatment history to be recordedin the OIS for use and display.
Indications for Use/Intended Use	The 4D Integrated TreatmentConsole is designed to assist theoperator of a radiation therapydevice in providing accuratetreatment setups for each patientby monitoring setup parametersand preventing the radiationtherapy device from commencingirradiation when any parameter isout of conformance with thetreatment plan	The 4D Integrated TreatmentConsole provides assistance foraccurate treatment delivery bymonitoring linear acceleratorparameters and preventing theradiation therapy device fromcommencing irradiation whenany parameter is out ofconformance with the treatmentplan
General Usage
Imaging Only Sessions	No	Yes
Ad hoc kV imaging supported	No	Yes
Support the saving ofAcquisition Module images inQA Mode	No	Yes
Conical Collimator support	Yes	Yes, Barcode Conical CollimatorVerification (BCCV) andIntegrated Conical collimatorVerification & Interlock system(ICVI)
Bolus	Yes, Barcode verification	Yes, Barcode verification andManual verification
Gantry angle acquired fortreatment fields with adhoc CBCTfields	Yes	No
Support for UnplannedTreatments	No.	Yes
Support for Flattening Filter Freetreatments	No	Yes
Delta couch shift	No	Yes
Features	Predicate Device4DITC (v8.8)K091132	Modified Device4DITC (v 13)
Enter in treatment notes andSSD's per plan/field	No	Yes
Support for multiple isocenterswith grouping in a single plan	No	Yes
Major plan edits	Yes	No
High Intensity Mode (HIM) Alsoknown as FFF (Flattening FilterFree)	No	Yes
UNIQUE Support	No	Yes
Varian Volumetric Modulated ArcTherapy (VVMAT vs. RapidArcsupport)	No	Yes
National Language Support(NLS)	No	Yes
Unicode Support	No	Yes
Stereotactic (SRS) - Dose Limitsupport for High Dose Technique	No	Yes
Integrated Conical CollimatorVerification	No	Yes, Integrated ConicalCollimator Verification andInterlock System (ICVI)

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Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255

Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com

Note the reasons for the removal of features:

1. Major Plan Edits: We are no longer supporting major plan edits which were User Riahts controlled outside of Unplanned Treatment Mode. This change will assure that edits to major plan parameters occur only in the Treatment Planning/Oncology Information Planning software or in the 4D Unplanned Treatment Mode.
1. Gantry angle acquired for treatment fields with adhoc CBCT fields: The intention of the feature was to allow the user to acquire the gantry angle on the adhoc CBCT field. The consequence was that the user could also acquire the new gantry angle for the treatment fields which is considered a major plan edit. Removing the capability to acquire the gantry angle for the treatment fields continues to allow the user to acquire the CBCT gantry angle, while honoring the Plan Edit Preferences in 4DITC Administration.

Verification and Validation Testing

Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.

Regression testing was performed to verify the integrity of any changes.

Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.

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K133331
page 4 of 4

VARŽAN

medical systems

3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com

Varian Medical Systems, Inc.

Verification &Validation Summary Report

Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human figure or a bird-like shape.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

January 27, 2014

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

Re: K133331

Trade/Device Name: 4d Integrated Treatment Console Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 28, 2013 · Received: October 29, 2013

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. 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); medical device reporting (reporting of medical 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.

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Page 2 - Mr. Peter J. Coronado

. . . .. .. .. .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/Safety/ReportaProblem/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133331

Device Name: 4D Integrated Treatment Console (4DITC)

Indications For Use:

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)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Page 1 of _ 1 __

K133331 510(k)

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.