4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)

K081036 · Varian Medical Systems, Inc. · IYE · May 9, 2008 · Radiology

Device Facts

• Record ID: K081036
• Device Name: 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

4D Integrated Treatment Console (4DITC) modified with Patient Accessory Verification System (PAVS); enhances radiation therapy safety. System inputs include bar code scans of patient accessories and patient identity verification. Clinical staff uses hand-held bar code scanner to verify accessories against treatment plan and confirm patient identity in treatment room. Software interlocks radiation beam until accessories are acknowledged by user. Used in clinical radiation therapy settings by trained staff. Output is verification status; prevents beam commencement if parameters are out of conformance. Benefits patient by reducing setup errors and ensuring treatment delivery matches plan.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based accessory and patient verification system; utilizes hand-held bar code scanners and label creation software. Integrates with existing radiation therapy console hardware. Operates via interlock logic to prevent radiation beam activation based on verification status.

Indications for Use

Indicated for patients undergoing radiation therapy; assists operators in ensuring accurate treatment setup by monitoring parameters and preventing irradiation if parameters deviate from the treatment plan.

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

• 4D Integrated Treatment Console (K050479)

Submission Summary (Full Text)

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K081636

MAY - 9 2008

:

# 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: April 9, 2008 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | 4D Integrated Treatment Console |
| Classification Name: | Medical charged-particle radiation therapy system,<br>21 CFR 892.5050, IYE, Class II |
| Common/Usual Name: | 4DITC |
| Predicate Devices: | 4D Integrated Treatment Console, K050479 |
| Device Description: | The 4D Integrated Treatment Console (4DITC) has been<br>modified to add a new capability called Patient Accessory<br>Verification System (PAVS). PAVS is a feature set of 4D ITC<br>that enhances treatment safety. This feature allows users to<br>identify accessories (not connected to the linac) for patients and<br>interlock the radiation beam until these devices have been<br>acknowledged by the end-user. Also, PAVS allows patient<br>verification between the patient on the treatment schedule with<br>the patient in the treatment room. This is accomplished using a<br>hand-held bar code scanner used in conjunction with software by<br>trained clinical staff. Staff defines which accessories require a<br>bar code label to be scanned. Clinical staff creates the labels for<br>the accessories using label creation software in Practice<br>Management and a label printer. Staff scans the appropriate<br>accessories for each patient's treatment field for accessory<br>selection verification. |
| Statement of<br>Indications for Use: | The 4DITC function is designed to assist the operator of a<br>radiation therapy device in providing accurate treatment setups<br>for each patient by monitoring setup parameters and preventing<br>the radiation therapy device from commencing irradiation when<br>any parameter is out of conformance with the treatment plan. |
| Technological<br>Characteristics: | Refer to the Substantial Equivalence Comparison Chart. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

Re: K081036

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: IYE Dated: April 8, 2008 Received: April 11, 2008

#### 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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### Page 2

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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4D Integrated Treatment Console

# Indications for Use

081036

510(k) Number (if known):

Device Name:

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.

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 Device Evaluation (ODE)

(Posted November 13, 2003)

Torri McWhan

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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ETPS_510(k) _IFU

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Date: May 10, 2007