(196 days)
Computer aided planning of static and dynamic conformal radiation therapy treatments. The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam's eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance of the BrainLab BrainScan Conformal RT Module. The document is an FDA 510(k) clearance letter from 1997, which confirms that the device is substantially equivalent to previously marketed devices for specific indications for use.
Therefore, I cannot provide the requested table and study details based on the given input.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1997
Stefan Vilsmeier President BrainLAB USA., Inc. 600 Glen Court Moorestown, NJ 08057 Re:
K971367 BrainLab BrainScan Conformal RT Module Dated: July 28, 1997 Received: July 31, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Vilsmeier:
We have reviewed your Section SI0(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 general controls provisions of the Act include requirements for annual registration, issing 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 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/dsmamain.html".
Sincerely vours.
W. Niau Yu
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
{1}------------------------------------------------
Page _ 1 __ of _______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K 971367
BrainSCAN Conformal RT Module Device Name:
Indications For Use:
Computer aided planning of static and dynamic conformal radiation therapy treatments.
The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam's eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.
System requirements: BrainSCAN Workstation (K915819/A)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter Use(Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT,and Radiological Devices | |
| 510(k) Number | K971367 |
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.