BRAINSCAN CONFORMAL RT MODULE

K971367 · Brainlab AG · IYE · Oct 27, 1997 · Radiology

Device Facts

• Record ID: K971367
• Device Name: BRAINSCAN CONFORMAL RT MODULE
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

BrainSCAN Conformal RT Module is a software-based planning tool for radiation therapy. It operates on the BrainSCAN Workstation. The system processes patient anatomical data to design static and dynamic conformal radiation treatments. It utilizes conformal block collimators (contour molded to lesion outline) or multileaf collimators to shape radiation beams in the beam's eye view. The device is used by clinicians to precisely target lesions while sparing surrounding healthy tissue and critical structures. The output assists in radiation treatment planning, enabling accurate dose delivery to the target volume.

Clinical Evidence

Bench testing only.

Technological Characteristics

Software-based radiation therapy planning module; operates on BrainSCAN Workstation; supports static and dynamic conformal radiation therapy; utilizes conformal block collimators or multileaf collimators for beam shaping.

Indications for Use

Indicated for patients requiring radiation therapy for lesions, where conformal block collimators or multileaf collimators are used to shape radiation beams to the target volume while sparing healthy tissue.

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

• BrainSCAN Workstation (K915819/A)

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion 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" (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 [phone] or [phone] 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<br>(Per 21 CFR 801.109) | <div style="display:inline-block; width:30px; border-bottom: 1px solid black;"></div> |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | OR |
| Over-The-Counter Use<br>(Optional Format 1-2-96) | <div style="display:inline-block; width:30px; border-bottom: 1px solid black;"></div> |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K971367 |