(88 days)
RTIS is an imaging accessory indicated for use with radiotherapy devices such as linear accelerators and simulators. It provides radiographic/fluoroscopic images for simulations, and portal images for high energy treatment machines.
RTIS is a component of imaging systems for use with radiotherapy devices such as linear accelerators and simulators for various imaging tasks. It may be integrated into systems such as Varian PortalVision® and VARiS® Digital Imaging Option and offers the capability of a realtime imager that can provide both high quality simulator fluoroscopic/radiographic images and high energy treatment images.
This document is a 510(k) premarket notification for the "Varian Radiation Therapy Imaging System (RTIS)". It describes the device, its intended use, and technological considerations, but does not contain details about acceptance criteria or a study proving its performance.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone performance) from the provided text.
The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, rather than providing a performance study report.
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AUG 15 1997
K97/839
varian@
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| 1. Submitter: | Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304 |
|---|---|
| --------------- | ----------------------------------------------------------------- |
Contact: Charles H. Will, Manager Regulatory Compliance & Safety Phone: (415) 424-5036 (415) 424-4830 FAX:
May 15, 1997 Prepared:
Radiation Therapy Imaging System (RTIS) 2. Device Name:
- Predicate Device: Electronic Portal Imaging System 510(k) 901932B Cleared on May 3, 1991
- RTIS is a component of imaging systems for 4. Description: use with radiotherapy devices such as linear accelerators and simulators for various imaging tasks. It may be integrated into systems such as Varian PortalVision® and VARiS® Digital Imaging Option and offers the capability of a realtime imager that can provide both high quality simulator fluoroscopic/radiographic images and high energy treatment images.
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- Intended Use:
Allows the therapist to have the capability of a realtime imager that can provide either high quality simulator fluoroscopic/radiographic images or high energy treatment images.
- Intended Use:
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- Technological Considerations:
Whereas the imaging mechanism in the predicate Electronic Portal Imaging System is an ionization chamber, for RTIS it is an image detector. The image detector is a photo-diode array of thin film transistors (TFT) based on amorphous silicon technology. When used in combination with a scintillating material, the array can be used for x-ray imaging applications. The array contains 512 x 512 pixels which convert light into electrical charge. Each of the pixels contain a TFT which transfers the charge to the data lines when a voltage pulse is applied to the gate line. The charge is read from the data by external amplifiers.
- Technological Considerations:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Charles H. Will Manager, Regulatory-Compliance & Safety ........... Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129
Re:
................... Varian Radiation Therapy Image Acquisition System . Dated: May 15, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR 892.5840/Procode: 90 KPO
Dear Mr. Will:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 (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 requirement, 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 (301) 594-4613. Additionally, for question 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/dsmamain.html'
Sincerely vours.
h7 Niau Yri
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K971839 |
|---|---|
| Device Name: | Varian Radiation Therapy Imaging System (RTIS) |
| Indications For Use: | RTIS is an imaging accessory indicated for use withradiotherapy devices such as linear accelerators and simulators.It provides radiographic/fluoroscopic images for simulations,and portal images for high energy treatment machines. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Edward G. Skyson
(Division Sign-Off) (Division of Repreductive, Abdominal, ENT, and Radiological Devices 39 510(k) Number _
V Prescription Use Pcc 21 CFR 801.109
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.