VARIAN TREATMENT

K093967 · Varian Medical Systems, Inc. · IYE · Jul 12, 2010 · Radiology

Device Facts

• Record ID: K093967
• Device Name: VARIAN TREATMENT
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

Device Story

Varian Treatment (VT) is a software interface for Siemens, GE, and Elekta linear accelerators. It retrieves treatment plans and reference images from the Varian System Database; sends selected fields to the machine's treatment control software (TCS); verifies planned parameters against actual TCS delivery system parameters; prevents beam authorization if parameters are out of conformance; and records treatment data back to the Varian System Database. Used in clinical radiation therapy settings by oncology staff to ensure accurate patient set-ups and prevent irradiation errors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based interface device. Operates as a networked system connecting to linear accelerator treatment control software and the Varian System Database. Performs parameter verification and data transfer.

Indications for Use

Indicated for patients undergoing radiation therapy requiring linear accelerator set-up parameter monitoring to ensure conformance with treatment plans.

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

• Varian 4D Integrated Treatment Console (K050479)

Submission Summary (Full Text)

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# Premarket Notification 510(k) Summary

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way, E-110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: December 2009 | JUL 12 2010 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Proprietary Name: | Varian Treatment | |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II, MUJ | |
| Common/Usual Name: | Varian Treatment | |
| Predicate Devices: | Varian 4D Integrated Treatment Console, K050479 | |

#### Device Description:

Varian Treatment is a software device that performs an interface role to the Siemens, GE, and Elekta linear accelerator systems. Varian Treatment (VT) allows treatment plans and reference images to be retrieved from the Varian System Database. VT sends the selected field of the loaded treatment plan down to the machine's treatment control software (TCS). VT verifies the field's planned parameters against the actual parameters of the TCS delivery system for accuracy before beam authorization is granted; this process is repeated for each field selected by the user. VT creates and transfers treatment records to the Varian System Database for storage.

### Statement of Indications for Use:

Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

### Technological Characteristics:

Refer to the Substantial Equivalence Comparison Chart.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Vy Tran Vice President Corporate Regulatory Affairs Varian Medical Systems, Inc. 7 3100 Hansen Way PALO ALTO CA 94304-1038

JUL 1 2 2010

Re: K093967

Trade/Device Name: Varian Treatment Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 25, 2010 Received: May 27, 2010

Dear Ms. Tran:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Varian Treatment (VTx)

## Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

AND/OR

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

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

h. Dth
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
**Office of In Vitro Diagnostic Device Evaluation and Safety**

510K K693967

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