BRACHYVISION 6.0

K992762 · Varian Assoc., Inc. · MUJ · Mar 9, 2000 · Radiology

Device Facts

• Record ID: K992762
• Device Name: BRACHYVISION 6.0
• Applicant: Varian Assoc., Inc.
• Product Code: MUJ · Radiology
• Decision Date: Mar 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Brachyvision 6.0 is designed to allow the dose distribution of an implant or applicator to be individually shaped for each patient. Brachy Vision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy, using either temporary or permanent implants of various radioisotopes.

Device Story

Brachyvision 6.0 is a computer-based treatment planning system for brachytherapy. It accepts patient data via network, film scanner, digitizer, or keyboard. The system processes inputs to calculate and display prospective or verification treatment plans, including isodose distributions based on source placement. For remote afterloader devices, it optimizes source dwell times based on user-selected criteria. The system outputs data to a plotter. It is intended for use by clinicians to shape dose distributions for individual patients, aiding in clinical decision-making for radiation therapy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based planning system; includes graphics display, film scanner, and plotter output. Supports network connectivity and digitizer input. Software-based dose calculation and optimization algorithms.

Indications for Use

Indicated for brachytherapy planning in patients undergoing temporary or permanent radioisotope implants. Optimized for use with remote afterloaders (e.g., VariSource) and 3D imaging modalities including CT, MRI, and Ultrasound.

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

• Nucletron Plato Brachytherapy

Submission Summary (Full Text)

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

Page 1 of 2

# Date Summary was prepared:

August 12, 1999

## Submitter's Name:

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

#### Contact Person:

Linda S. Nash Regulatory Affairs and Quality Assurance Manager Phone [phone] [phone] FAX E-Mail [e-mail]

Device Name: Brachyvision 6.0

Classification Name: Source, Brachytherapy, Radionuclide

Predicate Device: Nucletron Plato Brachytherapy

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Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 650.493.4000 FAX: [phone]

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#### Product Description:

Brachy Vision is a computer based product used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of Brachytherapy. The system consists of a computer with graphics display, film scanner input, and plotter output. Patient data may be entered from network connection, via the film scanner, via the optional back lit digitizer, or via the keyboard. Source placement information may be added to the patient data and isodose distributions, which would result from those source placements, may be displayed, analyzed and plotted. For use with remote afterloader devices, source dwell times may be optimized to user selected criteria.

### Intended Use:

Brachyvision 6.0 is designed to allow the dose distribution of an implant or applicator to be individually shaped for each patient. Brachy Vision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy, using either temporary or permanent implants of various radioisotopes.

### Technological Characteristics:

See Specifications/Features Comparison Chart

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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

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MAR 9 2000

Linda Nash Regulatory Affairs & Quality Assurance Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto. California 94304-1129

Re:

K992762 BrachyVision 6.0 Dated: December 13, 1999 Received: December 14, 1999 Regulatory Class: II 21 CFR 892.5730/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 pror to May 26, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 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 notification 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/dsmamain.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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varian@ oncology systems

# Indications For Use

510(k) Number (if known): _ 192762

Device Name: Brachyvision 6.0

Indications for Use:

Brachy Vison 6.0 may be used for any brachytherapy planning activity, but has been specifically optimized for use with remote afterloaders (especially the VariSource unit from Varian), and for use with 3D images such as may be obtained from CT or MRI, or Ultrasound images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR (per 21 CFR 801.109)

Over-The-Counter Use___

David A. Simpson
(Division Sign-Off)

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

Image /page/3/Picture/12 description: The image shows a logo for "Partners for Life". The words "Partners For" are stacked on top of each other in a bold, sans-serif font. The word "Life" is written in a cursive font and is placed below the words "Partners For". The logo is black and white.

Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 650.493.4000 FAX: [phone]

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