(184 days)
Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Vision database.
Somavision is an advanced treatment planning preparation workstation with 3D image capabilities.
This document is a 510(k) Premarket Notification for the Varian SomaVision 6.0 device. It describes the device's intended use and technological characteristics, and ultimately summarizes the FDA's decision regarding its substantial equivalence to a predicate device.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request for this specific information based on the provided document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on detailed performance study results that would typically include acceptance criteria and study methodologies.
{0}------------------------------------------------
FEB 1 6 2000
Image /page/0/Picture/1 description: The image shows the logo for Varian Oncology Systems. The word "varian" is in bold, black letters, with a circled symbol to the right of the word. Below the word "varian" is the phrase "oncology systems" in a smaller, non-bold font.
K92751
Premarket Notification [510K] Summary as required by 21 CFR 807.92
age 1 of 2
Date Summary was prepared:
August 12, 1999
Submitter's Name:
Varian Medical Systems 3100 Hansen Way M/S H-055 Palo Alto, CA 94304
Contact Person:
Linda S. Nash Regulatory Affairs and Quality Assurance Manager Phone (650) 424-6990 FAX (650) 855- 7364 E-Mail linda.nash@os.varian.com
Device Name:
Somavision 6.0
Classification Name: System, Simulation, Radiation Therapy
Predicate Device: General Electric Advantage Sim
Image /page/0/Picture/14 description: The image shows the logo for "Partners for Life". The word "Partners" is stacked on top of the word "For", and the word "Life" is written in cursive and extends to the right. The logo is in black and white.
Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 650.493.4000 FAX: 650.424.4830
3 printed on recycled papes
{1}------------------------------------------------
Product Description:
Somavision is an advanced treatment planning preparation workstation with 3D image capabilities.
Intended Use:
The Varian SomaVision 6.0 device is a CT simulation system used for diagnostic image analysis, contouring & segmentation, geometrical planning and plan review
Technological Characteristics:
See the attached "Specification Comparison Chart", Tab F.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Linda S. Nash Regulatory Affairs and Quality Assurance Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, CA 94304-1129
Re: K992751
Soma Vision 6.0 (Radiation Therapy Simulation Software System Dated: November 18, 1999 Received: November 19, 1999 Regulatory class: II 21 CFR 892.5840/Procode: 90 KPO
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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or dass 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 equivalent determination 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. Fallure 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 the Electronic Product 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Varian Oncology Systems. The word "varian" is in bold, black letters on the top line, followed by a circled symbol. The words "oncology systems" are in smaller, non-bold, black letters on the second line. The logo is simple and professional.
Indications For Use
510(k) Number (if known):
Device Name: Somavision 6.0
Indications for Use:
Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Vision database.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter/Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992951
K992751
PARTNERS
£3 printed on recycled pap
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.