VISION (WITH OFF-LINE REVIEW)

K052391 · Varian Medical Systems · IYE · Nov 23, 2005 · Radiology

Device Facts

• Record ID: K052391
• Device Name: VISION (WITH OFF-LINE REVIEW)
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.

Device Story

Vision is a client-server application for radiation therapy treatment planning and image management. It ingests diagnostic studies, treatment plans, and simulation data. The new 'Off-Line Review' module enables radiation therapy staff to perform quantitative image matching (2D/3D kV image matching, field edge/structure matching) to define patient setup corrections. The system provides tools for manual or automatic anatomy matching, statistics/trends visualization, and export of correction data. Used by radiation therapy staff in clinical settings to verify treatments and manage dose delivery. Output assists clinicians in refining patient positioning for subsequent treatments, aiming to improve treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and functional comparison to the predicate device.

Technological Characteristics

Client-server software architecture; operates on networked workstations; integrates with common database server used by Varian systems (Eclipse, Acuity, PortalVision, VARiSVision). Features include image processing, quantitative matching algorithms, and data management tools.

Indications for Use

Indicated for radiation therapy staff to prepare and approve treatment plans, perform quality assurance of treatments, and follow-up on delivered treatments and doses to defined sites. Includes image acquisition, viewing, manipulation, treatment plan definition, and scheduling.

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

• Vision™ (K042956)

Reference Devices

• Eclipse
• Acuity
• PortalVision
• VARiSVision

Submission Summary (Full Text)

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510(k) Summary

K052391

The following information is provided following the format of 21CFR 807.92 for Vision™ with Off-Line Review feature.

NOV 2 3 2005

- 1. Submitter: Varian Medical Systems 3100 Hansen Way M/S E110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: August 29, 2005
### 2. Name of Device:

Trade/Proprietary name: Vision™ (with Off-Line Review) Common or Usual Name: Image Database Classification Name: Radiological Image processing system 21CFR §892.5840 Class II Product Code: 90 LLZ

- 3. Predicate Device: Vision™, K042956
#### 4. Description of the Device:

The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.

The Vision device (K042956) has been modified to introduce a module called Offline Review. Off-line Review allows the authorized user to review treatment images and provide capabilities to do quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images.

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The Vision device is based on the client-server architecture, and thus all Vision clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision).

#### 5. Intended Use Statement:

The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.

- 6. Summary of Technological Characteristics: The Substantial Equivalence Comparison chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 8 of the submission.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re.: K052391

NOV 2 3 2005

Trade/Device Name: Vision™ (with Off-Line Review) Regulation Number: 21 CFR 892.5050 21 CFR 892.5840 Regulation Name: Medical charged-particle radiation therapy system; Radiation therapy simulation system Regulatory Class: II Product Code: IYE; KPQ

Dated: August 29, 2005 Received: August 31, 2005

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 (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); 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.

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his icler with anow you'ts oogin mannelling of substantial equivalence of your device to a legally premarked predication: "The I Dr. missification 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 acriee tor your de 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 Also, production other general information on your responsibilities under the Act from the 007.777. I va may ooum barees, 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,

Nancy C. hogdon

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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# 510(k) Number (if known): Device Name: Vision™ with Off-Line Review

Indications For Use:

Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, vision is dosigned to abservate of the treatments, i.e. to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Dyson

livision Sig 510(k) Number

(Optional Format 3-10-98)

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