Varian Verification System (VVS)

• K Number: K142268
• Device Name: Varian Verification System (VVS)
• Manufacturer: VARIAN MEDICAL SYSTEMS, INC.
• Date Cleared: 2014-10-02 ( 48 days)
• Product Code: IYE
• Regulation Number: 892.5050

Intended Use

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.

Predicate Devices

K091132, K103394

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on verification and prevention based on pre-defined conformance rules, not on learning or adaptive algorithms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
The device is designed to assist in setting up a radiation therapy device and prevent irradiation if settings are incorrect, thereby ensuring accurate treatment delivery. It does not directly provide therapy.

Diagnostic

No

The device assists in verifying correct treatment setup and prevents irradiation if parameters are out of conformance with the treatment plan. It does not diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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)." While it includes software verification and validation, the description of combining existing systems and functioning "under 4D Integrated Treatment Console" implies integration with hardware components of a radiation therapy device, not a standalone software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is designed to assist in radiation therapy treatment setups by verifying patient, accessories, and collimator selection. This is a function related to the delivery of a medical treatment, not the diagnosis of a disease or condition.
• Device Description: The description reinforces the intended use, focusing on monitoring and preventing incorrect setups for radiation treatment.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is entirely focused on ensuring the correct setup for a radiation therapy procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IYE

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.

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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091132, K103394

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 [phone] or [phone] 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 [phone] or [phone] 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] 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-110
Palo Alto, CA 94304

Contact Name: Peter J. Coronado
Phone: [phone]
Fax: [phone] |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 14, 2014 |
| Proprietary Name: | Varian Verification System (VVS) |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: IYE |
| Common/Usual Name: | Varian Verification System (VVS) |
| Predicate Devices: | Patient Accessory Verification System (PAVS) of 4DITC – K091132
Barcode 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 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. |
| Intended Use Statement | 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. |
| Indications for Use Statement | 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 |

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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 Device
Clearance Number:	K091132	K103394	Not yet available
Indications for Use	The 4DITC function is
designed to assist
the operator of a
radiation therapy
device in providing
accurate treatment
setups for each
patient by monitoring
setup parameters
and preventing the
radiation therapy
device from
commencing
irradiation when any
parameter is out of
conformance with
the treatment plan.	Barcode Conical Collimator
Verification 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 a
conical collimator accessory
(accelerator accessory) and
preventing the radiation
treatment device from
commencing irradiation
when the selected conical
collimator is out of
conformance with the
treatment plan.	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.
Allows users to identify
accessories (not directly
connected to a linac) for
patient and interlock the
radiation beam until
these devices have been
acknowledged by the
end-user.	No (Conical
Collimators)	Yes (Conical Collimators)	Yes (Conical Collimators)
	Yes (block, bolus,
compensator)	No (block, bolus,
compensator)	Yes (block, bolus,
compensator)
Allows patient
verification between the
patient on the treatment
schedule with the
patient in the treatment
room.	Yes	No	Yes
A hand-held bar code
scanner is used in
conjunction with
software.	Yes	Yes	Yes
Supported Barcode
Reader	Datalogic barcode
reader GBT4100-BK	Datalogic barcode reader
GBT4100-BK	Datalogic Gryphon 4400-HC-
2D, part number
7820037470
FEATURE AND/OR	PATIENT ACCESSORY	BARCODE CONICAL	VARIAN VERIFICATION SYSTEM
SPECIFICATION OF
NEW/MODIFIED DEVICE	VERIFICATION SYSTEM
(PAVS) OF 4DITC	COLLIMATOR VERIFICATION
(BCCV)	(VVS 1.0)
User defines which
accessories require a
bar code label to be
scanned.	Yes (block, bolus,
compensator)	Yes (Conical Collimators)	Yes (Conical Collimators and
block, bolus, compensator)
User staff creates the
labels for the
accessories using label
creation software in
ARIA Oncology
Information System for
Radiation Oncology and
a label printer.	Yes (block, bolus,
compensator)	No (block, bolus,
compensator)	Yes (block, bolus,
compensator)
	No (Conical
Collimators)	No – pre-printed labels for
conical collimators are
provided as part of BCCV
system	No – pre-printed labels for
conical collimators are
provided as part of VVS
system
User scans the
appropriate accessories
for each patient's
treatment field for
accessory selection
verification.	Yes	Yes	Yes
Support for emergency
patient treatment when
the treatment plan is not
present in the Oncology
Information System	No	No	Yes
Consoles Supported	4DITC
TrueBeam
Varian Treatment	4DITC
TrueBeam	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.