EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM

K072046 · Brainlab AG · IYE · Oct 17, 2007 · Radiology

Device Facts

• Record ID: K072046
• Device Name: EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Oct 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ExacTrac 3rd Party system is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac 3rd Party uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable -- a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac 3rd Party system uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.

Device Story

ExacTrac 3rd Party is an image processing system for patient positioning in radiation therapy. It integrates with the MHI-TM2000 linear accelerator. Inputs include stereoscopic x-ray images or Cone Beam CT (CBCT) scans from the accelerator, and infrared tracking data from reflective markers. The system compares live images against reference images (DRRs from planning CT or CBCT) to calculate patient position offsets. It outputs correction shifts to the linear accelerator to adjust the treatment couch. Used in clinical radiation therapy settings by trained personnel. Benefits include improved accuracy in patient localization, ensuring precise radiation delivery to target volumes while sparing healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided. Validation was performed according to BrainLAB's internal procedures for product design and development to confirm safety and effectiveness.

Technological Characteristics

Image processing system for patient positioning. Inputs: stereoscopic x-ray, CBCT, infrared optical tracking. Connectivity: interfaces with MHI-TM2000 linear accelerator for data import and couch motion control. Software-based registration of live images to reference images (DRRs or planning CT).

Indications for Use

Indicated for patient positioning during radiation therapy using the MHI-TM2000 linear accelerator. Used for localization and correction of patient position before and during treatment via stereoscopic x-ray, cone beam CT registration, and optical tracking of infrared markers.

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 4.0 (K040585)

Submission Summary (Full Text)

{0}------------------------------------------------

K072046

0C1 1 7 2007

# 510 (k) Summary of Safety and Effectiveness for ExacTrac 3rd Party

| Manufacturer: | BrainLAB AG |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | May 16, 2007 |
| Device Name: | |
| Trade name: | ExacTrac 3rd Party, will also be marketed under the name<br>ExacTrac X-ray 6D 3rd Party, ExacTrac OEM |
| Common/Classification Name: | Patient Positioning System / System, Radiation Therapy, Charged-<br>Particle, Medical |

Predicate Device: ExacTrac 4.0 (K040585)

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

{1}------------------------------------------------

### Intended Use:

The ExacTrac 3 in Party system is intended to be used in conjunction with the MH-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.

ExacTrac 3 m Party uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.

The ExacTrac 3 ™ Party system uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.

### Device Description:

ExacTrac 3d Party is an Image Processing System for patient positioning on the MHI-TM2000 linear accelerator. 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

- a) digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and xray images (live images) from the imaging system of the MHI-TM2000 linear accelerator with the patient on the treatment couch.
- b) the treatment planning CT and a Cone Beam CT taken on the imaging system of the MHJ-TM2000 linear accelerator with the patient on the treatment couch.

The x-ray images, accomplished as stereoscopic x-rays or a Cone Beam CT scan, are created by the corresponding kV x-ray imaging system of the MHI-TM2000 linear accelerator and loaded into the ExacTrac 3rd Party System. Structures on the images to be compared can be either anatomical landmarks or implanted internal markers. Based on the imaging data, ExacTrac 3rd Party determines the correct treatment position, which is then applied by couch motion of the MHI-TM2000 linear accelerator.

### Substantial equivalence:

ExacTrac 3d Party has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device ExacTrac 4.0 (K040585)

{2}------------------------------------------------

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, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 1 7 2007

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY

Re: K072046

Trade/Device Name: ExacTrac 3te Party (BrainLAB's Patient Positioning System) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 6, 2007 Received: July 25, 2007

### 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.

{3}------------------------------------------------

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: ExacTrac 3rd Party (BrainLAB's Patient Positioning System)

Indications For Use:

# ExacTrac 3rd Party

The ExacTrac 3rd Party system is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.

ExacTrac 3rd Party uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable -- a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.

The ExacTrac 3rd Party system uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jonath Whan

on Sian-Off) Division of Reproductive, Abdo Radiological Devic 510(k) Number

Page 1 of 1