ExacTrac Dynamic

K220338 · Brainlab AG · IYE · Apr 29, 2022 · Radiology

Device Facts

• Record ID: K220338
• Device Name: ExacTrac Dynamic
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Apr 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Device Story

ExacTrac Dynamic is an add-on system for linear accelerators used in radiotherapy/radiosurgery. It uses patient planning/CT data, oblique X-ray images, and 3D/thermal surface cameras to determine and monitor patient position. The system calculates correction shifts for the treatment machine and provides a beam-hold signal if deviations occur. Version 1.1 adds Deep Inspiration Breath-Hold (DIBH) functionality for breast cancer treatment, utilizing a patient feedback system (in-room monitor) to help patients maintain breath-hold levels. Surface tracking monitors patient position relative to an initial 3rd-party positioning (e.g., CBCT) or during DIBH. Operated by clinical staff in a radiotherapy environment, the device ensures treatment occurs only when the patient is correctly positioned, minimizing radiation exposure to critical structures like the heart.

Clinical Evidence

Clinical investigation (n=13 female subjects, including breast cancer patients and healthy volunteers) evaluated the DIBH module. Objectives: verify ability to reproduce DIBH state within +/- 3 mm and pre-position patients with translational accuracy < 6 mm. All acceptance criteria passed; no adverse events reported. Supporting evidence includes literature review and phantom performance evaluation.

Technological Characteristics

Add-on system for linear accelerators. Components: Varex G-892 X-ray sources, Varex PaxScan 3030DX flat panel detectors, Cognex A5060 3D cameras, Flir A65 F25 thermal cameras. Connectivity: Networked for data import/machine communication. Software: Surface registration algorithm using thermal/spatial data to prevent local minima. DIBH module includes patient feedback system. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy for lesions, tumors, and conditions anywhere in the body. Includes breast cancer patients eligible for Deep Inspiration Breath-Hold (DIBH) technique.

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 Dynamic (K201276)

Submission Summary (Full Text)

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Brainlab AG % Chiara Cunico Manager RA Olof-Palme-Str. 9 Munich, 81829 GERMANY

Re: K220338

Trade/Device Name: ExacTrac Dynamic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 3, 2022 Received: February 18, 2022

Dear Chiara Cunico:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K220338

Device Name

ExacTrac Dynamic (1.1)

Indications for Use (Describe)

ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

April 22, 2022

| General Information | |
|-------------------------------|-------------------------------------------------------|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment<br>Registration | 8043933 |
| Device Name | Medical charged-particle radiation therapy system |
| Trade Name | ExacTrac Dynamic |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Devices | ExacTrac Dynamic (K201276) |

#### 1. Indications for Use

ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

#### 2. Device Description

ExacTrac Dynamic is a patient positioning device used in a radiotherapy environment as an addon system to standard linear accelerators. It uses patient planning and CT data to determine the patient's planned position and compares it via oblique x-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment is monitored with a surface camera and X-ray to ensure no misalignment due to patient movement.

ExacTrac Dynamic 1.1 is a modification of the previously cleared device ExacTrac Dynamic 1.0 that additionally features a Deep Inspiration Breath-Hold (DIBH) functionality to treat breast cancer. This functionality helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology. This functionality was not included in ExacTrac Dynamic 1.0. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined position with a maximum distance to critical structures like the heart. Additionally, the surface tracking functionality was extended, which monitors the patient after an initial 3rd party positioning.

#### 3. Substantial Equivalence

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| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for<br>Use | ExacTrac Dynamic is intended to position patients<br>at an accurately defined point within the treatment<br>beam of a medical accelerator for stereotactic<br>radiosurgery or radiotherapy procedures, to<br>monitor the patient position and to provide a beam<br>hold signal in case of a deviations in order to treat<br>lesions, tumors and conditions anywhere in the<br>body when radiation treatment is indicated. | ExacTrac Dynamic is intended to position patients<br>at an accurately defined point within the treatment<br>beam of a medical accelerator for stereotactic<br>radiosurgery or radiotherapy procedures, to<br>monitor the patient position and to provide a beam<br>hold signal in case of a deviations in order to treat<br>lesions, tumors and conditions anywhere in the<br>body when radiation treatment is indicated. | No changes |
| Localization<br>technique | The camera detects both the patient surface and<br>the patient thermal surface which together, can be<br>used to track the patient geometries.<br>Stereo X-ray is acquired and compared with the<br>planned position (room based).<br>CBCT data are imported from a from 3rd party<br>CBCT Device and compared with the planned<br>position. | The camera detects both the patient surface and<br>the patient thermal surface which together, can be<br>used to track the patient geometries.<br>Stereo X-ray is acquired and compared with the<br>planned position (room based).<br>CBCT data are imported from a from 3rd party<br>CBCT Device and compared with the planned<br>position. | Same as the predicate device. |
| General<br>workflow:<br>Patient<br>preparation<br>before using<br>ExacTrac | Uses implanted radio opaque fiducial markers or<br>using Body Markers Performing CT scan<br>Data import from treatment planning system | Uses implanted radio opaque fiducial markers or<br>using Body Markers Performing CT scan<br>Data import from treatment planning system | Same patient preparation<br>method as the predicate |
| Software<br>User<br>Management | Done via Windows user management according to<br>our instructions | Done via Windows user management according to<br>our instructions | Identical to the predicate |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| Deep<br>Inspiration<br>Breath-Hold<br>(DIBH) | N/A | ExacTrac Dynamic 1.1 features a Deep Inspiration<br>Breath-Hold (DIBH) functionality to treat breast<br>cancer. This functionality includes special features<br>and workflows to correctly position the patient to a<br>deep inspiration breath-hold level and then to<br>monitor this position using the ExacTrac surface<br>tracking and x-ray positioning technology. The aim<br>of this technology is to treat the patient only during<br>breath-hold phases where the breast is at a<br>defined position with a maximum distance to<br>critical structures like the heart. These feature<br>results in an optional use of the patient feedback<br>system. | New feature added |
| Surface Only | N/A | Additionally, a separate workflow offers the<br>possibility to position the patient with a third-party<br>positioning device e.g., CBCT. The patient<br>position defined by the third-party device can be<br>set as a reference for ExacTrac Dynamic which<br>allows monitoring the patient using ExacTrac's<br>surface camera and X-ray system relative to this<br>position. ExacTrac Dynamic 1.1 shall offer<br>performing this third-party positioning and<br>ExacTrac Dynamic monitoring workflow by only<br>using the surface tracking system - contrary to<br>ExacTrac Dynamic 1.0 where it was necessary to<br>acquire X-ray images to set the third party defined<br>patient position as a reference for ExacTrac<br>Dynamic | New feature added |
| X-ray<br>Generator | The X-ray Generator consists of two HFe 601 X-<br>ray Generators. Each generator controls one X-<br>ray tube. Software control of X-ray settings.<br>Updated electronic board for the updated tubes. | No change compared to ExacTrac Dynamic 1.0 | No changes |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| ExacTrac<br>Console | ExacTrac Console (System start/shut down, X-ray<br>acquisition)<br>Image: ExacTrac Dynamic 1.0 K201276 Console | ExacTrac Console (System start/shut down, X-ray<br>acquisition)<br>Image: ExacTrac Dynamic 1.1 Console | No change |
| X-ray Sources | Varex G-892 Sources (Housing: Varex B-130) | Varex G-892 Sources (Housing: Varex B-130) | No change |
| Flat Panel<br>Detector<br>including<br>Power Supply | Flat Panel Detector<br>Varex PaxScan 3030DX | no change compared to predicate | No change |

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| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Cameras | 3D and Thermal Cameras<br>Manufacturer (3D): Cognex Ireland Limited Type:<br>A5060<br>Manufacturer (Thermal): Flir Systems AB Type:<br>A65 F25<br>Image: Camera<br>The camera is used to detect the patient's thermal<br>and spatial surface. The thermal topology is used<br>to prevent the surface registration algorithm from<br>falling into local minima. Thus, both surfaces are<br>used to track patient's position. | 3D and Thermal Cameras<br>Manufacturer (3D): Cognex Ireland Limited Type:<br>A5060<br>Manufacturer (Thermal): Flir Systems AB Type:<br>A65 F25<br>Image: Camera<br>The camera is used to detect the patient's thermal<br>and spatial surface. The thermal topology is used<br>to prevent the surface registration algorithm from<br>falling into local minima. Thus, both surfaces are<br>used to track patient's position. | no change |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| Wall mounted<br>Touch Screen<br>Monitor | Image: ExacTrac Dynamic 1.0 K201276 | Image: ExacTrac Dynamic 1.1 | No change |
| On Floor X-<br>ray sources<br>covers | X-ray tubes within On-Floor Boxes<br>X-ray Tubes within Floor | X-ray tubes within On-Floor Boxes<br>X-ray Tubes within Floor | No change |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary<br>Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| In Floor | The In-Floor is used to install on Varian and<br>Elekta LINAC's | Update of In- Floor Covers including a yellow light<br>and updated design. | Update of design, including<br>added light. No functional<br>change |
| Patient<br>Feedback<br>System | Not included | The Patient Feedback System helps patients<br>visualize their own respiration and to achieve a<br>correct breath hold.<br>Therefore, the mirror is attached the patient head<br>and they can see the in Room Monitor.<br>The Monitor shows the live respiratory status and<br>the DIBH Gating Window. The System is only for<br>supporting the patients, a treatment without is also<br>possible. | New part introduced due to the<br>addition of DBIH feature. |
| X-ray<br>Calibration | Image: X-ray Calibration | Image: X-ray Calibration | No change |
| Camera<br>Calibration | Thermal to 3D Calibration Phantom<br>A phantom to calibrate the 3D camera and the<br>thermal camera added. | Thermal to 3D Calibration Phantom<br>A phantom to calibrate the 3D camera and the<br>thermal camera added. | No change |

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#### 4. Performance Data

The following tests were conducted:

- . Compatibility Tests:
- Cybersecurity Tests: ●
- o ETD Pen Test
- o Vulnerability Test
- . Accuracy Test: The test objective is to verify that accuracy specifications for positioning and monitoring of ExacTrac Dynamic are not affected by the selected workflow, treatment parameters and different phantom positions. Also, within this test plan the correct display of deviation indicators and X-ray/DRR overlays as well as the correct transfer and adjustment of shifts and rotations to the patient support system.
- . Biological Evaluation: It examines the materials used in the device, considers the application of biological and chemical tests, and the history of safety and efficacy of the device materials in humans.
- . Usability Evaluation
- Routine Software verification to confirm that the specifications met the requirements

#### Clinical Validation

For the new feature, a clinical evaluation was performed which was based on literature review, performance evaluation on phantoms and a clinical investigation for DIBH.

#### Overview of the Pre-market, single-center Clinical Investigation:

Since the functionality to generate a respiratory signal is new to the Subject Device, a clinical investigation was performed to evaluate the surface camera system-based components of the ETD DIBH module.

#### Study Objectives:

- 1. ETD can assist a human eligible for DIBH (Paul Keall, 2006) to reproduce a defined state of deep inspiration breath-hold (DIBH) within +/- 3 mm.
- 2. Regarding the pre-positioning within the DIBH workflow based on ETD's 3D' surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.

Study population: 13 female subjects.

The first study population (patient population), consisted of subjects who are women who were diagnosed with breast cancer that is indicated for a treatment with radiation therapy with the DIBH technique and who are currently, or who have currently been treated with this technique.

The second study population (volunteer population) consisted of subjects who are healthy women who resembled patients that are typically diagnosed with breast cancer as far as possible, concerning their physiognomy and age, and who can perform sufficiently deep and long DIBHs.

All acceptance criteria for the successful completion of the study were passed. No adverse events or adverse device deficiencies were observed.

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### 5. Conclusion

Based on the clinical and non-clinical testing conducted for the Subject Device as listed above and based on the Substantial Equivalence discussion, the Subject Device was demonstrated to be as safe and effective as the predicate device.