Varian Verification System (VVS)

K142268 · Varian Medical Systems, Inc. · IYE · Oct 2, 2014 · Radiology

Device Facts

• Record ID: K142268
• Device Name: Varian Verification System (VVS)
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Oct 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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 Story

Varian Verification System (VVS) integrates two existing systems: Patient Accessory Verification System (PAVS) and Barcode Conical Collimator Verification (BCCV). Device uses hand-held barcode scanner (Datalogic Gryphon 4400-HC-2D) to read labels on patients, patient-specific accessories, and conical collimators. Software compares scanned data against treatment plan stored in ARIA Oncology Information System. If scanned items match plan, system allows irradiation; if mismatch occurs, system interlocks radiation device to prevent treatment. Used in clinical radiation therapy settings by radiation therapists/technicians. Benefits include reduced risk of treatment errors due to incorrect accessory or patient selection. Supports emergency treatment workflows when plans are absent from OIS.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation performed per FDA guidance for major level of concern software.

Technological Characteristics

System utilizes barcode scanning technology for verification. Components include Datalogic Gryphon 4400-HC-2D barcode reader. Software-based verification and interlock system. Integrates with ARIA Oncology Information System for treatment plan data. Operates on 4DITC console. Software classified as major level of concern.

Indications for Use

Indicated for patients undergoing radiation therapy; assists operators in verifying correct patient identity, patient-specific accessories (block, bolus, compensator), and conical collimator accessories against the treatment plan to prevent irradiation errors.

Regulatory Classification

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.

Predicate Devices

• Patient Accessory Verification System (PAVS) of 4DITC (K091132)
• Barcode Conical Collimator Verification (BCCV) (K103394)

Submission Summary (Full Text)

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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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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.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br><br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 14, 2014 |
| Proprietary Name: | Varian Verification System (VVS) |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: IYE |
| Common/Usual Name: | Varian Verification System (VVS) |
| Predicate Devices: | Patient Accessory Verification System (PAVS) of 4DITC – K091132<br>Barcode Conical Collimator Verification (BCCV) K103394 |
| Device Description: | Varian Verification System (VVS) is a new product combining two existing products:<br>Barcode Conical Collimator Verification (BCCV) and Patient Accessory Verification System<br>(PAVS) under 4D Integrated Treatment Console (4DITC). With VVS the features of both<br>BCCV and PAVS can be present, or alternatively, features of only BCCV or only PAVS. Key<br>features include operator assistance in providing accurate treatment setups for each<br>patient by monitoring the correct selection of patient, patient-specific accessories and<br>conical collimator accessory. Also the system prevents the radiation treatment device<br>from commencing irradiation when the selected patient, patient-specific accessories or<br>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<br>in providing accurate treatment setups for each patient by monitoring the correct<br>selection of patient, patient-specific accessories, conical collimator accessory and<br>preventing the radiation treatment device from commencing irradiation when the<br>selected patient, patient-specific accessories or conical collimator are out of<br>conformance with the treatment plan. |
| Indications for Use Statement | Varian Verification System is designed to assist the operator of a radiation therapy device<br>in providing accurate treatment setups for each patient by monitoring the correct<br>selection of patient, patient-specific accessories, conical collimator accessory and<br>preventing the radiation treatment device from commencing irradiation when the<br>selected patient, patient-specific accessories or conical collimator are out of<br>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<br>Clearance Number: | K091132 | K103394 | Not yet available |
| Indications for Use | The 4DITC function is<br>designed to assist<br>the operator of a<br>radiation therapy<br>device in providing<br>accurate treatment<br>setups for each<br>patient by monitoring<br>setup parameters<br>and preventing the<br>radiation therapy<br>device from<br>commencing<br>irradiation when any<br>parameter is out of<br>conformance with<br>the treatment plan. | Barcode Conical Collimator<br>Verification is designed to<br>assist the operator of a<br>radiation therapy device in<br>providing accurate<br>treatment setups for each<br>patient by monitoring the<br>correct selection of a<br>conical collimator accessory<br>(accelerator accessory) and<br>preventing the radiation<br>treatment device from<br>commencing irradiation<br>when the selected conical<br>collimator is out of<br>conformance with the<br>treatment plan. | Varian Verification System is<br>designed to assist the<br>operator of a radiation<br>therapy device in providing<br>accurate treatment setups<br>for each patient by<br>monitoring the correct<br>selection of patient, patient-<br>specific accessories, conical<br>collimator accessory and<br>preventing the radiation<br>treatment device from<br>commencing irradiation<br>when the selected patient,<br>patient-specific accessories<br>or conical collimator are out<br>of conformance with the<br>treatment plan. |
| Allows users to identify<br>accessories (not directly<br>connected to a linac) for<br>patient and interlock the<br>radiation beam until<br>these devices have been<br>acknowledged by the<br>end-user. | No (Conical<br>Collimators) | Yes (Conical Collimators) | Yes (Conical Collimators) |
| | Yes (block, bolus,<br>compensator) | No (block, bolus,<br>compensator) | Yes (block, bolus,<br>compensator) |
| Allows patient<br>verification between the<br>patient on the treatment<br>schedule with the<br>patient in the treatment<br>room. | Yes | No | Yes |
| A hand-held bar code<br>scanner is used in<br>conjunction with<br>software. | Yes | Yes | Yes |
| Supported Barcode<br>Reader | Datalogic barcode<br>reader GBT4100-BK | Datalogic barcode reader<br>GBT4100-BK | Datalogic Gryphon 4400-HC-<br>2D, part number<br>7820037470 |
| FEATURE AND/OR | PATIENT ACCESSORY | BARCODE CONICAL | VARIAN VERIFICATION SYSTEM |
| SPECIFICATION OF<br>NEW/MODIFIED DEVICE | VERIFICATION SYSTEM<br>(PAVS) OF 4DITC | COLLIMATOR VERIFICATION<br>(BCCV) | (VVS 1.0) |
| User defines which<br>accessories require a<br>bar code label to be<br>scanned. | Yes (block, bolus,<br>compensator) | Yes (Conical Collimators) | Yes (Conical Collimators and<br>block, bolus, compensator) |
| User staff creates the<br>labels for the<br>accessories using label<br>creation software in<br>ARIA Oncology<br>Information System for<br>Radiation Oncology and<br>a label printer. | Yes (block, bolus,<br>compensator) | No (block, bolus,<br>compensator) | Yes (block, bolus,<br>compensator) |
| | No (Conical<br>Collimators) | No – pre-printed labels for<br>conical collimators are<br>provided as part of BCCV<br>system | No – pre-printed labels for<br>conical collimators are<br>provided as part of VVS<br>system |
| User scans the<br>appropriate accessories<br>for each patient's<br>treatment field for<br>accessory selection<br>verification. | Yes | Yes | Yes |
| Support for emergency<br>patient treatment when<br>the treatment plan is not<br>present in the Oncology<br>Information System | No | No | Yes |
| Consoles Supported | 4DITC<br>TrueBeam<br>Varian Treatment | 4DITC<br>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.