ON-BOARD IMAGER DEVICE

K042720 · Varian Medical Systems · IYE · Oct 29, 2004 · Radiology

Device Facts

• Record ID: K042720
• Device Name: ON-BOARD IMAGER DEVICE
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Oct 29, 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) device modified to integrate cone-beam CT (CBCT) acquisition capability into treatment room environment. Device enables acquisition of CBCT images while patient is positioned on treatment couch. Clinicians compare soft-tissue anatomy in acquired CBCT images against reference CT scans (from conventional CT, Acuity simulator, or prior OBI scans). System facilitates verification of patient position relative to isocenter and treatment field alignment with anatomical/fiducial landmarks. Used in radiation therapy clinics by radiation oncologists/therapists to improve treatment accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Imaging accessory for medical linear accelerators. Integrates CBCT acquisition hardware and software. Operates within radiation therapy treatment room. Connectivity supports reference image import from external CT sources and simulators.

Indications for Use

Indicated for patients undergoing radiation therapy requiring verification of patient positioning relative to isocenter and treatment field alignment using 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

• On Board Imager (K040192)

Reference Devices

• Acuity simulator (K033339)

Submission Summary (Full Text)

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# OCT 2 9 2004

K042720

## 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 E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: September 30, 2004
### 2. Name of the Device:

Trade/Proprietary Name: Common or Usual Name: Classification Name:

On-Board Imager Device Imaging Accessory to Medical Linear Accelerator Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 IYE

#### 3. Predicate Devices to claim substantial equivalence:

- a. Varian Medical Systems'On Board Imager, K040192
- 4. Device Description: The On-Board Imager device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339) so that cone-beam CT image acquisition will be available in the treatment room. This will allow users to acquire cone-beam CT images of the patient while they are on the treatment couch in the treatment room. The users can then compare the locations of soft-tissue anatomy seen in reference CT scans with the locations of the same soft-tissue anatomy in the cone-beam CT images. The reference CT images can come from multiple sources including conventional CT scanners, the Acuity simulator or previous cone-beam CT scans acquired using the On-Board Imager.
- 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.
- Summary of the Technological Characteristics: The Substantial Equivalence 6. 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

OCT 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vy Tran Corporate Director, Regulatory Affairs VARIAN Medical Systems, Inc. 3100 Hansen Way M/S E-110 PALO ALTO CA 94304-1038

#### Re: K042720

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: September 30, 2004 Received: October 1, 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 (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.

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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 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 807.97). 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/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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## PAGE 1 of 1

510(k) Number (if known): K042720 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*

Nancy C. Broadlon

ACTIVE