4D INTEGRATED TREATMENT CONSOLE

K050479 · Varian Medical Systems · IYE · Mar 24, 2005 · Radiology

Device Facts

• Record ID: K050479
• Device Name: 4D INTEGRATED TREATMENT CONSOLE
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

Device Story

4D Integrated Treatment Console acts as a centralized workstation for radiation therapy management; integrates control of linear accelerator, PortalVision, multi-leaf collimator, and On-Board Imager. Operator (clinician/technician) uses console to select patients from schedule, retrieve treatment plans, and monitor setup parameters. Device compares real-time parameters against planned values; prevents irradiation if parameters are out of conformance. Provides functionality to edit positional data, evaluate dose limits, and record treatment data to information systems. Enables override of parameters based on user rights. Centralized interface improves workflow efficiency and enhances patient safety by ensuring treatment delivery matches the prescribed plan.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Workstation-based software interface for radiation therapy control. Integrates with linear accelerators, imaging systems (PortalVision, On-Board Imager), and multi-leaf collimators. Connectivity via networked information systems. Operates as a verification and control console for radiation therapy delivery.

Indications for Use

Indicated for use by operators of radiation therapy devices to assist in providing accurate treatment set-ups by monitoring parameters and preventing irradiation when parameters are out of conformance with 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

• Varis 1.4g (K001643)

Submission Summary (Full Text)

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K050479

MAR 2 4 2005

## 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the 4D Integrated Treatment Console.

1. Submitter: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: [e-mail] Date summary was prepared: February 23, 2005

## 2. Name of the Device:

| Trade/Proprietary Name: | 4D Integrated Treatment Console |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Accessory to Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy<br>System<br>21 CFR §892.5050<br>Class II<br>Product Code: 90 IYE |

3. Predicate Devices to claim substantial equivalence:

- a. Varian Medical Systems' Varis 1.4g (K001643)
4. Device Description: The 4D Integrated Treatment Console provides the user with:

- a treatment verification function to assist the operator of a radiation . therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and to prevent the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
- the ability to select patients from a queue provided by the schedule .
- the ability to retrieve plans from the information system for the selected . patient
- the ability to evaluate a selected treatment plan to determine whether . redefined dose limits will be exceeded

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- the ability to acquire and edit positional data from radiation therapy . devices
- the ability to override treatment parameters based on user rights .
- the ability to send treatment records to an information system i .
- the ability to interact with the user controls of the Portalvision, the multi-. the ability to microom and the treatment verification function on a single workstation.
- Provides access to the linear accelerator and the On-Board Imager. .
- 5. Intended Use Statement: 4D Integrated Treatment Console is designed to assist mentour Obe Baltimion therapy device in providing accurate treatment set-ups the operator of a rationing set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
- 6. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050479 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: February 23, 2005 Received: February 24, 2005

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 (Premarket Approval), 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.

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.

MAR 2 4 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse orgal finding of substantial equivalence of your device to a legally prematics notification: "The PDF management of 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 If you desire specific act not 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" (21 CFR Act from be the regulation other general information on your responsibilities under the Act from the 001:27). I ou may 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 yours,

Nancy C. 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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510(k) Number (if known): KOSO479 Device Name: 4D Integrated Treatment Console

Indications For Use:

The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters de hee in pro riains accurate therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

*Prescription Use*

Thancy C. Brogdon

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