EXACTRAC 4.0 AND EXACTRAC X-RAY 6D

K040585 · Brainlab AG · IYE · May 11, 2004 · Radiology

Device Facts

• Record ID: K040585
• Device Name: EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: May 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

ExacTrac 4.0 is 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 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.

Device Story

Patient positioning system for stereotactic radiosurgery/radiotherapy; uses optical tracking of infrared markers and X-ray registration to locate patient relative to linear accelerator isocenter. Inputs: CT-based digital reconstructed images (DRR), X-ray images, or ultrasound images (for prostate). Operation: compares reference images (CT) with real-time X-ray or ultrasound to verify/correct patient position via anatomical landmarks or internal markers. Used in clinical radiation therapy settings by trained personnel. Output: positional verification/correction data; enables precise radiation delivery; improves treatment accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by verification and validation testing performed according to manufacturer's design and development procedures.

Technological Characteristics

Patient positioning system; utilizes optical tracking (infrared markers), X-ray imaging, and optional ultrasound module. Integrates with planning systems or simulators for isocenter import. Software-based image comparison (DRR vs. X-ray/ultrasound).

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.

Predicate Devices

• ExacTrac (K003285)

Submission Summary (Full Text)

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## MAY 11 2004

# 510 (k) Summary of Safety and Effectiveness K84058 for ExacTrac 4.0®

### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | March 03, 2004 |
| Device Name: | |
| Trade name: | ExacTrac4.0, will also be marketed under the name |
| | ExacTrac X-ray 6D |
| Common/Classification Name: | Patient Positioning System / System, Radiation Therapy, Charged-<br>Particle, Medical |

### Predicate Device: ExacTrac (K003285)

Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulatory Class: Class II

X-ray Generator Device Classification Name: Generator, High Voltage X-Ray, Diagnostic Regulatory Class: Class I Exempt Accession Number: 0110172-00

X-ray Tubes Device Classification Name: Assembly, Tube Housing, X-Ray, Diagnostic Regulatory Class: Class I Exempt Accession Number: 7410266-15

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#### Intended Use:

ExacTrac 4.0 is 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 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.

#### Device Description:

ExacTrac 4.0 is a Patient Positioning System. It is based on an imported isocenter from a planning system or on an isocenter imported from a simulator. It allows verification and, if necessary correction of the patient's position.

Correction of patient's position is based on a comparison of digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and x-ray images) . Structures on the images to be compared can be either anatomical landmarks or implanted internal markers.

For some applications (e.g. prostate tumors) the correction can alternatively be performed by using the ultrasound module. Here the correction of patient's position is based on a comparison of an outlined structure in the CT set (reference image) and perpendicular ultrasound images) .

#### Substantial equivalence:

ExacTrac 4.0 has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 {k} application was found to be substantially equivalent with the predicate device ExacTrac 2.0 (K003285)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 11 2004

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten GERMANY

Re: K040585 Trade/Device Name: ExacTrac 4.0 Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 4, 2004 Received: March 5, 2004

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040585

510(k) Number (if known):

ExacTrac 4.0

Device Name: (BrainLAB's Patient Positioning System)

Indications For Use:

# ExacTrac 4.0

ExacTrac 4.0 is 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 Exact on 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as that nethod of locating the position of the patient.

(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

(Optional Format 1-2-96)

Division Sign Division of Reprodu and Radiological D 510(k) Number