ON-BOARD IMAGER DEVICE

K040192 · Varian Medical Systems, Inc. · IYE · Feb 27, 2004 · Radiology

Device Facts

• Record ID: K040192
• Device Name: ON-BOARD IMAGER DEVICE
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Device Story

On-Board Imager (OBI) is an imaging accessory for medical linear accelerators; adds kilovoltage (kV) X-ray source and digital imaging system to existing PortalVision platform. Device captures radiographic images to verify patient positioning relative to isocenter and treatment field alignment with anatomical or fiducial landmarks. Used in clinical radiation therapy settings by radiation oncology staff. Provides high-quality images to supplement or replace standard portal imaging, enabling precise patient setup before treatment delivery. Output allows clinicians to adjust patient position, ensuring accurate radiation dose delivery to target volumes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing comparisons.

Technological Characteristics

Imaging accessory for medical linear accelerators; incorporates kilovoltage (kV) X-ray source and digital imaging system. Designed to supplement or operate with PortalVision. Technical specifications and comparison to predicates provided in submission Tab 8.

Indications for Use

Indicated for patients undergoing radiation therapy requiring verification of patient position relative to isocenter and treatment field alignment with anatomical or fiducial landmarks.

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

• PortalVision (K003636)
• Elekta Synergy (K032996)

Submission Summary (Full Text)

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Ko 40192

## 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the On-Board Imager Device.

1. Submitter: Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: January 27, 2004

| 2. | Name of the Device: | On-Board Imager |
|----|-------------------------|------------------------------------------------------|
| | Trade/Proprietary Name: | On-Board Imager Device |
| | Common or Usual Name: | Imaging Accessory to Medical Linear Accelerator |
| | Classification Name: | Medical Charged Particle Radiation Therapy<br>System |
| | | 21 CFR §892.5050 |
| | | Class II |
| | | Product Code: 90 IYE |

- 3. Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems'PortalVision, K003636
- b. Elekta Synergy, K032996
- 4. Description of the Device: PortalVision has been modified to add a kilovoltage xray source and digital imaging system to allow for improved image quality. This additional option will be called the On-Board Imager device and its intended use will be to supplement the PortalVision device or be used as a stand-alone device to allow for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation anatomical and/or fiducial landmarks.
- 5. Intended Use Statement: The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
- 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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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular pattern around the left side of the eagle. The word "USA" is on the right side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2004

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

Re: K040192

Trade/Device Name: On-Board Imager Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE

Dated: January 27, 2004 Received: January 28, 2004

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.

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,

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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Indications for Use

510(k) Number (if known): K040192

Device Name: On-Board Imager

Indications for Use:

The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Prescription Use × (Part 21 CFR 801 Subpart D)

.

Over-The-Counter Use (21 CFR 807 Subpart C)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040192