PORTALVISION ADVANCED IMAGING

K091209 · Varian Medical Systems, Inc. · IYE · Jun 23, 2009 · Radiology

Device Facts

• Record ID: K091209
• Device Name: PORTALVISION ADVANCED IMAGING
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The PortalVision™ Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

Device Story

PortalVision Advanced Imaging (PVAI) is an accessory to Varian Linear Accelerators; used in clinical radiotherapy settings. Device hardware includes detector support arm (R-Arm or Exact Arm) and image acquisition system. Inputs: MV radiographic images, treatment beam shape, dosimetric signals. Software enables remote patient position correction from treatment console. Clinicians use output images to verify patient positioning and beam alignment relative to anatomical landmarks or fiducial markers. Benefits include improved accuracy in radiation delivery guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory to Varian Linear Accelerator; includes detector support arm (R-Arm/Exact Arm) and image acquisition system for MV radiographic imaging. Software provides remote patient position correction functionality.

Indications for Use

Indicated for patients requiring radiation therapy, to guide radiation delivery by imaging anatomical landmarks, fiducial markers, treatment beam shape, and dosimetric signals anywhere in the body.

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

• Varian PortalVision (K003636)
• Varian Radiotherapy Imaging System (RTIS) (K971839)

Submission Summary (Full Text)

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#### 510(k) Summary

Kcg1209

The information below is provided for the Modifications to Portal Vision™ known as PortalVision Advanced Imaging, following the format of 21 CFR 807.92.

1. Submitter:

Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]

# JUN 23 2009

2. Name of the Device: Trade / Proprietary Name: Common or Usual Name: Classification Name:

PortalVision™ Advanced Imaging PortalVision™ Advanced Imaging PortalVision™ Advanced Imaging Medical Charged Particle Radiation Therapy System 21 CFR \$892.5050 lass-II-

Product Code:

- Predicate Device to claim substantial equivalence: 3. Varian PortalVision -- K003636 and Varian Radiotherapy Imaging System (RTIS) - K971839
- 4. Description of the Device:

The Portal Vision Advanced Imaging (PVAI) device combines two previously cleared Varian Medical Systems devices into a single device

The PVAI device provides hardware and software for acquiring MV images and is an accessory to Varian Linear Accelerator devices. The hardware component of PortalVision™ Advanced Imaging consists of a detector support arm known as the R-Arm or Exact Arm, and an image acquisition system that provides highquality radiographic images and high-energy treatment images. The software component of the modification known as PortalVision™ Advanced Imaging provides additional capability to remotely correct the patient position from the treatment console.

- 5. Intended Use Statement
The Portal Vision™ Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

Indications for Use Statement 6.

> The PortalVision™ Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

#### 7. Substantial Equivalence

The submission for the PortalVision™ Advanced Imaging device Interface illustrates substantial equivalence to the predicate devices.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The emblem is a stylized representation of a staff with a snake coiled around it.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 2 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091209

Trade/Device Name: PortalVision Advanced Imaging Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 23, 2009 Received: April 24, 2009

#### 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 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrth/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Janine M. Morris

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in capital letters, with the "I" stylized to resemble a person. Below the word "VARIAN" are the words "medical systems" in a smaller font.

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] www.varian.com

### Indications for Use Statement

510(k) Number (if known):

K091209

Device Name:

PortalVision Advanced Imaging

The PortalVision Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR § 801.109)

Over-the-counter

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