MODIFICATION TO: ON-BOARD IMAGER DEVICE

K041519 · Varian Medical Systems, Inc. · IYE · Aug 4, 2004 · Radiology

Device Facts

• Record ID: K041519
• Device Name: MODIFICATION TO: ON-BOARD IMAGER DEVICE
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 4, 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. It acquires digital kV X-ray images to verify patient positioning and treatment field alignment. Modifications allow for fiducial marker comparison against 3-D volumetric reference data, gated radiographic image acquisition, and fluoroscopic pretreatment visual verification. Used in clinical radiation therapy settings by trained personnel. Output consists of digital images used by clinicians to assess patient alignment relative to the treatment isocenter. Enables precise positioning adjustments prior to radiation delivery, potentially improving treatment accuracy.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and technical comparison.

Technological Characteristics

Imaging accessory for medical linear accelerators; kV X-ray source and digital detector; supports 2D radiographic, fluoroscopic, and gated imaging; integrates with 3-D volumetric reference data sets for fiducial marker alignment.

Indications for Use

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

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

• On Board Imager (K040192)

Submission Summary (Full Text)

{0}------------------------------------------------

K041519

AUG = 4 2004

## 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: June 4, 2004

| 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<br>21 CFR §892.5050<br>Class II<br>Product Code: 90 IYE |

- 3. Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems'On Board Imager, K040192
- 4. Device Description: The present device (K040192) is cleared to make corrections to a patient's position based on a comparison of the newly acquired digital kV Xray images with digital reference images generated during treatment planning or simulation. Regarding this submission, the On-Board Imager has been modified to include correction of a patient's position based on comparison of fiducial markers in digital images to fiducial markers that are in reference 3-D volumetric data sets and allow for gated radiographic image acquisitions and fluoroscopic pretreatment visual verification.
- 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.

{1}------------------------------------------------

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 stylized eagle-like figure with three curved lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

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

Re: K041519

Trade/Device Name: On-Board Imaging Device Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 IYE Dated: July 16, 2004 Received: July 19, 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 for association 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

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hantoling of substantial equivalence of your device to a legally premarket notification. The PDA miding of casion 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 If you desire specific advice for your device to for the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [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 Audultionally, for questions on the promote the regulation entitled, "Misbranding Other of Comphanes at (301) 37 + 1057 + 1057 + 1007.97) you may obtain. Other general by recreence to premarred nombilities under the Act may be obtained from the Division of Small information on your responsionities and consumer Assistance at its toll-free number [phone] or 1911) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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

Enclosure

Page 2

{3}------------------------------------------------

510(k) Number (if known): K041519 Device Name: On-Board Imager Device

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

Nancy C. Gordon
(Division Sign-Off)

Division of Reproductive, Abdeminal, and Radiological Devic 510(k) Number