Varian Verification System is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring the correct selection of patient, patient-specific accessories, conical collimator accessory and preventing the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan.

Device Description

Varian Verification System (VVS) is a new product combining two existing products: Barcode Conical Collimator Verification (BCCV) and Patient Accessory Verification System (PAVS) under 4D Integrated Treatment Console (4DITC). With VVS the features of both BCCV and PAVS can be present, or alternatively, features of only BCCV or only PAVS. Key features include operator assistance in providing accurate treatment setups for each patient by monitoring the correct selection of patient, patient-specific accessories and conical collimator accessory. Also the system prevents the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan.

AI/ML Overview

The Varian Verification System (VVS) is a medical device designed to assist operators of radiation therapy devices in ensuring accurate treatment setups for patients. It does so by monitoring the correct selection of patient-specific accessories and conical collimators and preventing treatment if there's a mismatch with the treatment plan.

Based on the provided Premarket Notification [510(k)] Summary, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative format with performance values. Instead, it describes the functionalities and safety checks that the VVS provides, implying these functionalities are the "acceptance criteria" that the device must successfully perform. The device's performance is demonstrated through software verification and validation.

Implied Acceptance Criteria (based on Device Description and Intended Use) and Reported Performance:

Acceptance Criteria (Functionality)	Reported Device Performance (as per document)
Correct selection of patient-specific accessories: Ability to monitor and confirm the use of the correct patient-specific accessories (e.g., blocks, boluses, compensators) according to the treatment plan.	VVS allows users to identify accessories (block, bolus, compensator) for patients and interlocks the radiation beam until these devices have been acknowledged. User staff creates labels for accessories using ARIA and a label printer. User scans appropriate accessories for verification.
Correct selection of conical collimator accessory: Ability to monitor and confirm the use of the correct conical collimator accessory according to the treatment plan.	VVS allows users to identify conical collimators and interlocks the radiation beam until these devices have been acknowledged. Pre-printed labels for conical collimators are provided as part of the VVS system. User scans appropriate accessories for verification.
Prevention of irradiation when out of conformance: The device must prevent the radiation treatment device from commencing irradiation if the selected patient, patient-specific accessories, or conical collimator are not in conformance with the plan.	This is fundamentally covered by the "interlock" mechanism described for both patient accessories and conical collimators. The system "prevents the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan."
Patient verification: Ability to verify the patient on the treatment schedule with the patient in the treatment room.	VVS supports patient verification between the patient on the treatment schedule and the patient in the treatment room.
Support for hand-held barcode scanner: Integration and functionality with a hand-held barcode scanner for verification.	VVS uses a hand-held barcode scanner (Datalogic Gryphon 4400-HC-2D).
User-defined accessory configuration: Ability for users to define which accessories require barcode labels to be scanned.	VVS allows users to define which accessories (Conical Collimators and block, bolus, compensator) require a barcode label to be scanned.
Support for emergency patient treatment: Provision for emergency treatment when the treatment plan is not present in the Oncology Information System.	VVS supports emergency patient treatment when the treatment plan is not present in the Oncology Information System.

Description of the Study that Proves the Device Meets Acceptance Criteria:

The key study mentioned is "Software Verification and Validation Testing."

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

The document does not specify a sample size for a "test set" in the context of clinical or performance data for the VVS.
The study described is "Software Verification and Validation Testing," which typically involves testing software functionalities against requirements. It does not refer to a patient dataset in the way a clinical study would.
Data Provenance: Not applicable in the context of "Software Verification and Validation Testing" as described for a software-based device verification system. No patient data or geographical origin is mentioned.

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

This information is not provided in the document. Software Verification and Validation Testing for a device like this would typically involve internal software engineers and quality assurance personnel, rather than experts establishing "ground truth" derived from medical images or patient outcomes. The "ground truth" here is the expected behavior and output of the software according to its design specifications.

4. Adjudication Method for the Test Set:

This information is not provided as it pertains to clinical data or expert consensus, which are not detailed in the context of this software verification and validation.
For software testing, "adjudication" would typically involve reviewing test results against expected outcomes, bug reporting, and resolution processes by the development and QA teams.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or reported. The document explicitly states: "Clinical Tests No clinical tests have been included in this pre-market submission."
Therefore, there is no information about the effect size of human readers improving with or without AI assistance. The VVS is a verification system, not an AI-assisted diagnostic or treatment planning system that would involve human readers interpreting output in that manner.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The "Software Verification and Validation Testing" effectively serves as the standalone performance evaluation of the VVS.
The system itself is designed to operate without continuous human intervention for its core verification tasks (i.e., it automatically monitors and interlocks based on selected items). The human "in the loop" is the operator who scans barcodes and acknowledges items, but the verification logic itself is standalone. The document states: "The software for this device was considered as a 'major' level of concern." This indicates a high level of rigor in the standalone software testing.

7. Type of Ground Truth Used:

The ground truth for the "Software Verification and Validation Testing" is the design specifications and functional requirements of the VVS. The software is tested to confirm it correctly implements these predefined rules for monitoring accessory selection, patient verification, and preventing irradiation when conditions are not met.
It is not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical performance studies.

8. Sample Size for the Training Set:

This information is not applicable or not provided. The VVS appears to be a rule-based or deterministic system (i.e., barcode scanning and comparison to a treatment plan database), not a machine learning or AI system that requires a "training set" in the conventional sense.

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

This information is not applicable as the device does not appear to utilize a "training set" in the context of machine learning. The "ground truth" for its operation is embedded in its design specifications and the data it receives from the treatment plan and scanned barcodes.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2014

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

Re: K142268

Trade/Device Name: Varian Verification System (VVS) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 14, 2014 Received: August 15, 2014

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education 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.

Michael D'Hara
for

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)

K142268

Device Name Varian Verification System

Indications for Use (Describe)

Varian Verification System is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring the correct selection of patient-specific accessories, conical collimator accessory and preventing the radiation treatment device from commencing irradiation when the selected patient, patientspecific accessories or conical collimator are out of conformance with the treatment plan.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Premarket Notification [510(k)] Summary

Varian Verification System

The following information is provided following the format of 21 CFR 807.92(c).

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200
Date:	August 14, 2014
Proprietary Name:	Varian Verification System (VVS)
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: IYE
Common/Usual Name:	Varian Verification System (VVS)
Predicate Devices:	Patient Accessory Verification System (PAVS) of 4DITC – K091132Barcode Conical Collimator Verification (BCCV) K103394
Device Description:	Varian Verification System (VVS) is a new product combining two existing products:Barcode Conical Collimator Verification (BCCV) and Patient Accessory Verification System(PAVS) under 4D Integrated Treatment Console (4DITC). With VVS the features of bothBCCV and PAVS can be present, or alternatively, features of only BCCV or only PAVS. Keyfeatures include operator assistance in providing accurate treatment setups for eachpatient by monitoring the correct selection of patient, patient-specific accessories andconical collimator accessory. Also the system prevents the radiation treatment devicefrom commencing irradiation when the selected patient, patient-specific accessories orconical collimator are out of conformance with the treatment plan.
Intended Use Statement	Varian Verification System is designed to assist the operator of a radiation therapy devicein providing accurate treatment setups for each patient by monitoring the correctselection of patient, patient-specific accessories, conical collimator accessory andpreventing the radiation treatment device from commencing irradiation when theselected patient, patient-specific accessories or conical collimator are out ofconformance with the treatment plan.
Indications for Use Statement	Varian Verification System is designed to assist the operator of a radiation therapy devicein providing accurate treatment setups for each patient by monitoring the correctselection of patient, patient-specific accessories, conical collimator accessory andpreventing the radiation treatment device from commencing irradiation when theselected patient, patient-specific accessories or conical collimator are out ofconformance with the treatment plan

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Technological Characteristics:

FEATURE AND/OR	PATIENT ACCESSORY	BARCODE CONICAL	VARIAN VERIFICATION SYSTEM
SPECIFICATION OF	VERIFICATION SYSTEM	COLLIMATOR VERIFICATION
NEW/MODIFIED DEVICE	(PAVS) OF 4DITC	(BCCV)	(VVS 1.0)
Predicate DeviceClearance Number:	K091132	K103394	Not yet available
Indications for Use	The 4DITC function isdesigned to assistthe operator of aradiation therapydevice in providingaccurate treatmentsetups for eachpatient by monitoringsetup parametersand preventing theradiation therapydevice fromcommencingirradiation when anyparameter is out ofconformance withthe treatment plan.	Barcode Conical CollimatorVerification is designed toassist the operator of aradiation therapy device inproviding accuratetreatment setups for eachpatient by monitoring thecorrect selection of aconical collimator accessory(accelerator accessory) andpreventing the radiationtreatment device fromcommencing irradiationwhen the selected conicalcollimator is out ofconformance with thetreatment plan.	Varian Verification System isdesigned to assist theoperator of a radiationtherapy device in providingaccurate treatment setupsfor each patient bymonitoring the correctselection of patient, patient-specific accessories, conicalcollimator accessory andpreventing the radiationtreatment device fromcommencing irradiationwhen the selected patient,patient-specific accessoriesor conical collimator are outof conformance with thetreatment plan.
Allows users to identifyaccessories (not directlyconnected to a linac) forpatient and interlock theradiation beam untilthese devices have beenacknowledged by theend-user.	No (ConicalCollimators)	Yes (Conical Collimators)	Yes (Conical Collimators)
	Yes (block, bolus,compensator)	No (block, bolus,compensator)	Yes (block, bolus,compensator)
Allows patientverification between thepatient on the treatmentschedule with thepatient in the treatmentroom.	Yes	No	Yes
A hand-held bar codescanner is used inconjunction withsoftware.	Yes	Yes	Yes
Supported BarcodeReader	Datalogic barcodereader GBT4100-BK	Datalogic barcode readerGBT4100-BK	Datalogic Gryphon 4400-HC-2D, part number7820037470
FEATURE AND/OR	PATIENT ACCESSORY	BARCODE CONICAL	VARIAN VERIFICATION SYSTEM
SPECIFICATION OFNEW/MODIFIED DEVICE	VERIFICATION SYSTEM(PAVS) OF 4DITC	COLLIMATOR VERIFICATION(BCCV)	(VVS 1.0)
User defines whichaccessories require abar code label to bescanned.	Yes (block, bolus,compensator)	Yes (Conical Collimators)	Yes (Conical Collimators andblock, bolus, compensator)
User staff creates thelabels for theaccessories using labelcreation software inARIA OncologyInformation System forRadiation Oncology anda label printer.	Yes (block, bolus,compensator)	No (block, bolus,compensator)	Yes (block, bolus,compensator)
	No (ConicalCollimators)	No – pre-printed labels forconical collimators areprovided as part of BCCVsystem	No – pre-printed labels forconical collimators areprovided as part of VVSsystem
User scans theappropriate accessoriesfor each patient'streatment field foraccessory selectionverification.	Yes	Yes	Yes
Support for emergencypatient treatment whenthe treatment plan is notpresent in the OncologyInformation System	No	No	Yes
Consoles Supported	4DITCTrueBeamVarian Treatment	4DITCTrueBeam	4DITC

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Performance Data:

Software Verification and Validation Testing

Software verification and validation was 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.

Clinical Tests No clinical tests have been included in this pre-market submission

Conclusions

The non-clinical data support the safety of the device and the software verification and validation demonstrate that the VVS device performs as intended. Varian therefore considers VVS to be safe and effective and to perform at least as well as the predicate devices.

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.