EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)

K983660 · Brainlab, Inc. · LHN · Jul 14, 1999 · Radiology

Device Facts

• Record ID: K983660
• Device Name: EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
• Applicant: Brainlab, Inc.
• Product Code: LHN · Radiology
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.

Device Story

ExacTrac is a patient positioning system for stereotactic radiosurgery/radiotherapy. It utilizes infrared cameras to track reflective markers placed on the patient; data is processed by a computer workstation to determine patient position relative to the linear accelerator isocenter. The system assists clinicians in aligning patients precisely for radiation delivery. Used in clinical settings by radiation oncology staff. Benefits include improved accuracy in patient setup for targeted radiation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components include infrared cameras, computer workstation, reflective markers, and calibration tools. Operates via optical tracking of infrared markers. Intended for use with linear accelerators.

Indications for Use

Indicated for patients undergoing stereotactic radiosurgery or radiotherapy procedures requiring precise positioning at the isocenter of a linear accelerator.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service 12 2022 2

100 11 2017 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUI 14 1999

Rainer Birkenbach BrainLAB USA, Inc. Building 4A, Mailstop E233 3100 Hanson Way Palo Alto, CA 94304

Re: K983660

> Trade Name: ExacTrac (BrainLAB Patient Positioning System) Regulatory Class: II Product Code: 90-LNH/ 892.5050 Dated: April 7, 1999 Received: April 12, 1999

Dear Mr. Birkenbach:

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 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 (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 assumply with the GMP requiration may result in requlatory 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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/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

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510(k) Number (if known):

Device Name: ExacTrac (BrainLAB Patient Positioning System)

Indications For Use:

## ExacTrac

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT

and Radiological I Prescription Use 510(k) Number (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format I-2-96)