EXACTRAC VERO

K122451 · Brainlab AG · IYE · Sep 28, 2012 · Radiology

Device Facts

• Record ID: K122451
• Device Name: EXACTRAC VERO
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K122451 · Sep 28, 2012	EXACTRAC VERO	Brainlab AG	Retrospective clinical data (breathing and tumor motion correlation); Existing x-ray image sets from routine clinical use of predicate devices	The sponsor used retrospective analysis of clinical breathing/tumor motion data and existing clinical x-ray image sets to validate the device's ability to track moving targets and perform patient positioning.	Retrospective analysis; Routine clinical use; Tumor motion; X-ray image sets

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of correlation between breathing and tumor motion; Retrospective analysis	Patients undergoing radiation therapy (implied by routine clinical use)	Not applicable for this study	Correlation between breathing and tumor motion
Analysis of existing x-ray image sets; Retrospective analysis	Patients treated with predicate devices	Not applicable for this study	Patient positioning accuracy

Indications for Use

ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero 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. ExacTrac Vero 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. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

Device Story

ExacTrac Vero is a patient positioning and monitoring system for the MHI-TM2000 linear accelerator. Inputs include stereoscopic X-ray images, cone beam CT (CBCT) data, and infrared (IR) tracking of external surrogate markers. The system compares acquired images/CBCT against treatment planning CT data to calculate patient position correction shifts. For moving targets, it correlates external IR marker motion with internal marker positions (detected via X-ray) to provide real-time pan/tilt position data to the gantry head controller, enabling continuous beam alignment. Used in clinical radiation therapy settings by trained personnel. Output consists of correction shifts and gantry motion data exported to the accelerator controller. Benefits include improved target localization and beam alignment accuracy, particularly for breathing-induced target motion.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, including software stress/memory leakage tests, EMC testing, and biocompatibility. Clinical validation relied on literature review, simulated treatment of anthropomorphic human-bone phantoms in a simulated clinical environment, retrospective analysis of tumor/breathing motion correlation, and analysis of existing X-ray image sets from predicate device clinical use.

Technological Characteristics

System integrates stereoscopic X-ray imaging, CBCT, and infrared optical tracking. Connectivity includes data export to MHI-TM2000 linear accelerator controller. Software-based image registration and motion correlation algorithms. Components verified via stress testing and drawing review. Biocompatible materials used for markers. Operates as an add-on to the MHI-TM2000 system.

Indications for Use

Indicated for patients undergoing radiation therapy requiring precise positioning and monitoring, including tracking of moving targets, using the MHI-TM2000 linear accelerator system.

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 3rd Party (K072046)
• Synchrony® Respiratory Tracking System (K120233)

Submission Summary (Full Text)

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K122451

# 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR EXACTRAC VERO

.

| Manufacturer: | Brainlab AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 8/9/2012 |
| Device: | ExacTrac Vero |
| Trade name: | ExacTrac® Vero |
| Common/Classification<br>Name: | Patient Positioning System, Radiation Therapy, Charged-Particle, Medical |
| Predicate Device: | ExacTrac 3rd Party (K072046)<br>Synchrony® Respiratory Tracking System (K120233) by Accuray Inc. |
| Device classification<br>name: | System, Radiation Therapy, Charged-Particle, Medical |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.5050 |
| Product Code: | IYE |
| Indication for use | ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000<br>radiation therapy linear accelerator system manufactured by Mitsubishi Heavy<br>Industries, Ltd. |
| | ExacTrac Vero uses the images received from the MHI-TM2000 linear<br>accelerator for analyzing the current patient position and calculating - when<br>applicable - a necessary correction shift. The correction shift is then exported<br>to the MHI-TM2000 linear accelerator. |
| | ExacTrac Vero uses stereoscopic x-ray or cone beam CT registration and<br>optical tracking of infrared reflective markers in order to localize and correct<br>the patient position before and during treatment. |
| | Optionally ExacTrac Vero provides position data for the pan/tilt motion of the<br>TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of<br>the beam orientation with a moving target. The position data is based on target<br>detection via X-ray imaging and IR tracking of external surrogate markers. |

FORM 04-195

REVISION 1

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#### Device description:

ExacTrac Vero is a patient positioning and monitoring system for the MHI-TM2000 Linear Accelerator System by Mitsubishi Heavy Industries Ltd. providing the following main features:

- Patient positioning based on comparison between X-ray images and . CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data and CT data provided by a treatment planning system.
- Optionally providing position data for the pan/tilt motion of the MHI-. TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data is based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.
- Monitoring of the patient position during treatment. .

The following main functionalities were already available for the predicate device ExacTrac 3td Party (K072046) and have been found to be substantially equivalent:

- Patient positioning based on comparison between X-ray images, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- Both modalities can be based on anatomical landmarks or implanted . markers.
- . Monitoring of the patient position during treatment.

The new functionality for treatment of moving targets was found to be substantially equivalent with the predicate device Synchrony® Respiratory Tracking System (K120233) by Accuray Inc.

This new feature provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data are based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.

Changes to Predicate Device ExacTrac 3"d Party (K072046):

ExacTrac Vero introduces a new functionality that provides in combination with the MHI-TM2000 linear accelerator the option of aligning the treatment beam with moving targets. This new function provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with the breathing induced movement of the target.

FORM 04-195

Technological characteristics and substantial equivalence:

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### Statement regarding nonclinical tests:

When verifying the design the following methods were used:

- Software memory leakage tests using special libraries or tools. .
- . Software stress tests with e.g. random input, low memory conditions, network failure, low, high, positive/negative values, etc.
- Stepping through the code using the debugger focusing on the data flow. .
- Check every compiler warning and remove the cause for the warning . (although some warnings still remain due to old code basis).
- . Code reviews.
- Use of a dynamic analysis tool. .
- . Usability tests, prototyping and tests in simulated environment.
- . Worst case analysis of an assembly to verify that components are designed properly and not subject to overstress during handling and use.
- . Drawing review.
- Stress tests of material to verify that it does not break, including safety . margins i.e. 4x or 8x its weight.
- Biocompatibility tests. .
- Prototyping. .
- EMC testing in accredited laboratory. .
- � Testing in clinical similar environment for usability.

For the clinical evaluation the following validation methods and data sources have been used:

- Literature review. .
- Simulated treatment of anthropomorphic human-bone phantoms within a . simulated clinical environment.
- Retrospective analysis of correlation between breathing and turnor motion. .
- . Analysis of existing x-ray image sets acquired during routine clinical use of predicate devices.

Conclusions

Statement regarding

clinical performance

data

ExacTrac Vero has been verified and validated according to Brainlab procedures for design and development. The verification and validation proves the safety and effectiveness of the system. The information provided by Brainlab in this 510 (k) application was found to support a substantial equivalence decision.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - W066-G609 Silver Spring, MD 20993-0002

Mr. Alexander Schwiersch Regulatory Affairs Manager Brainlab AG-R&D RT Kapellenstraße 12 Feldkirchen, Bavaria 85622 GERMANY

Re: K122451

Trade/Device Name: Exactrac Vero Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 9, 2012 Received: August 13, 2012

Dear Mr. Schwiersch:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html,

Sincerely Yours,

Janine M. Morris

Director Bivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

510(k) Number (if known): K122451

Device name: ExacTrac Vero

Indication for use:

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

ExacTrac Vero 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.

ExacTrac Vero 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.

Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

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 In Vitro Diagnostic Devices (OIVD)

Munkel D. O'Dell

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Sa

510(k) K122451

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