PROTON VISION 7.0

K002312 · Varian Medical Systems, Inc. · MUJ · Aug 30, 2000 · Radiology

Device Facts

• Record ID: K002312
• Device Name: PROTON VISION 7.0
• Applicant: Varian Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Aug 30, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.

Device Story

ProtonVision 7.0 is a computer-based treatment planning system for proton radiation therapy. It ingests diagnostic images to perform contouring and segmentation; calculates proton energy range, dose compensation, and dose distribution; and facilitates plan review. Used in clinical settings by radiation oncology staff to prepare 3D treatment plans for proton accelerators (70-235 MeV). The system integrates with the Varian Vision database and SomaVision software to support the overall therapy workflow. Output consists of prospective or verification treatment plans, which clinicians use to guide proton beam delivery, aiming to optimize dose distribution to target tissues while sparing healthy anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based software system for radiation therapy planning. Features include diagnostic image analysis, contouring, segmentation, proton energy range estimation, dose compensation, and dose calculation. Integrates with Varian Vision database and SomaVision. Operates on standard computer hardware with graphics display and plotter output.

Indications for Use

Indicated for planning proton radiation therapy treatments using proton accelerators (70-235 MeV). Supports 3D radiotherapy planning for rectangular, circular, regular, and irregular fields using customized blocking and compensators. Includes tools for diagnostic image analysis, contouring, segmentation, and plan review.

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

• ProtonVision 7.0 (K000922)

Reference Devices

• Soma Vision (K992751)

Submission Summary (Full Text)

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AUG 3 0 2000

K002312
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Image /page/0/Picture/2 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved top and a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.

alo Alto, CA 94304-1038 [phone] w.varian.com

## Premarket Notification [510K] Summary as required by 21 CFR 807.92

Date Summary was prepared; July 26, 2000

#### Submitter's Name:

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

Contact Person: Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance [phone] Phone FAX [phone] E-Mail [e-mail]

Device Name: ProtonVision 7.0

Classification Name: Medical Charged Particle Radiation Therapy Systems

Predicate Device: ProtonVision 7.0, K000922

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K002312
Page 2 of 2

### Product Description:

The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose
calculation and dosimerice plan review. Proton Vision integrates proton treatment planning
with

## Intended Use:

The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.

#### Technological Characteristics :

See attached Specification Comparison Chart, Tab F

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2000

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems 3100 Hansen Way M/S E-055 Palo Alto, CA 94304-1129

Re: K002312

Proton Vision 7.0.3 Radiation Therapy Treatment Planning System Dated: July 26, 2000 Received: July 31, 2000 21 CFR §892.5050/Procode: 90 MUJ

Dear Ms. Nash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, aqainst misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not ification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnoslic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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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 a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and expertise.

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

## Indications For Use

# 510(k) Number: K 002312

Device Name: ProtonVision 7.0

Indications For Use:

The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.

As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K00231

Prescription Use OR (per 21 CFR 801.109)

Over-The-Counter Use_