ExacTrac Dynamic 1.1.2
Device Facts
| Record ID | K231052 |
|---|---|
| Device Name | ExacTrac Dynamic 1.1.2 |
| Applicant | Brainlab AG |
| Product Code | IYE · Radiology |
| Decision Date | May 11, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
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.
Device Story
ExacTrac Dynamic is an add-on system for linear accelerators used in radiotherapy environments. It utilizes patient planning CT data, oblique X-ray images, and surface/thermal camera tracking to align patients at a defined treatment isocenter. The system monitors patient position during treatment; if deviations occur, it provides a beam hold signal to the accelerator. It includes Deep Inspiration Breath-Hold (DIBH) functionality for breast cancer treatment, allowing monitoring of breath-hold phases to maximize distance from critical structures like the heart. The system is operated by clinical staff in a radiotherapy suite. Outputs include calculated correction shifts for patient alignment and real-time monitoring data. The device benefits patients by ensuring precise radiation delivery and minimizing exposure to healthy tissue through automated beam control and motion management.
Clinical Evidence
Bench testing only. The submission relies on verification testing of software bug fixes and modified specifications. No clinical data was required or provided.
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 within radiotherapy suite. Software: Windows-based, rule-based logic for patient positioning, surface tracking, and beam hold signaling. Calibration: Thermal-to-3D phantom. No changes to hardware or core architecture from predicate.
Indications for Use
Indicated for patients requiring stereotactic radiosurgery or radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
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 1.1 (K220338)
Submission Summary (Full Text)
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May 11, 2023
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Brainlab AG % Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, 81829 GERMANY
Re: K231052
Trade/Device Name: ExacTrac Dynamic (1.1.2) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 11, 2023 Received: April 13, 2023
Dear Sadwini Suresh:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner -S. The date of the signature is 2023.05.11, and the time is 11:34:19 -04'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K231052
Device Name
ExacTrac Dynamic (1.1.2)
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)
| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## 510(k) Summary
K231052
May 11, 2023
| General Information | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Device Name | Medical charged-particle radiation therapy system |
| Trade Name | ExacTrac Dynamic 1.1.2 |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Devices | ExacTrac Dynamic 1.1 (K220338) |
| Contact Information | |
| Primary Contact | Sadwini Suresh<br>QM Consultant, Regulatory Affairs<br>Phone: +49 89 99 15 68 0<br>Email: regulatory.affairs@brainlab.com |
| Alternate Contact | Chiara Cunico<br>Senior Manager Regulatory Affairs<br>Phone: +49 89 99 15 68 0<br>Email: chiara.cunico@brainlab.com |
#### 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 1.1.2 is a modification of the previously cleared device ExacTrac Dynamic 1.1 that 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. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined
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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.
The main functionalities has remained same for the Subject Device. The modifications are done on a specification level to implement additional measures.
#### 3. Performance Data
In order to address the identified bugs, certain specifications and tests related to the bug fixes (as detailed in Section 4) with ExacTrac Dynamic 1.1.2 were modified to include additional measures. These modified specifications were verified via incremental tests. All tests were passed.
#### 4. Substantial Equivalence
The Subject Device has similar functionality, intended use, technological characteristics, and typical users as the predicate device. The change was performed to correct the identified bugs in the predicate device ExacTrac Dynamic 1.1.
The bug fix did not require any change to the existing software architecture.
The following critical bug was identified:
| Short name /<br>Specification | Bugzilla ID | Description |
|-------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| procedure without beam<br>hold control – Amiens<br>(Case-20221124-<br>451154) | Bug 154505 | In the Treatment application it is possible to treat<br>a DIBH patient with disabled beam control, i.e. if<br>a DIBH plan is prepared with disabled beam<br>control, treatment is not blocked. |
The following specifications were added for this bug:
- . In the Prep Application the software shall check the setting "Beam Control" of a DIBH Patient and shall not allow to save a DIBH patient with beam control disabled.
- . In the Template Editor it shall not be possible to save a new customer template if the DIBH workflow is selected and automatic "Beam Control" is disabled.
- In the Treatment App during the patient opening the setting "Beam Control" of a DIBH Patient ● shall be checked and in case Beam Control is disabled the patient shall not be loaded.
In addition, the following bugs were also fixed for the Subject Device version:
#### Table 1: List of Bugfixes
| Short name | Bugzilla ID | Description |
|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No deletion is possible<br>although archiving proxy is<br>configured | 155619 | it is not possible to delete patient without previously<br>have pressed archive button although the data is<br>already archived automatically through the<br>implementation of the bug 154028. |
| Possibility to achieve<br>Monitoring having positioned<br>with a setup beam which has<br>different isocenter | 155252 | For plans containing an additional setup beam with<br>a "virtual" isocenter, i.e. an isocenter different than<br>the isocenter of the treatment beam, it is possible to<br>position and treat the patient on the virtual isocenter<br>instead on the treatment isocenter. |
| Short name | Bugzilla ID | Description |
| There is a wrong<br>dependency/rule that<br>excludes ContentManager<br>2.8 | 155034 | Wrong dependency in the top level package |
| DIBH procedure without<br>beam hold control – Amiens<br>(Case-20221124-451154) | 154506 | In the Template Editor it is possible to prepare a<br>DIBH template with disabled beam control, i.e. that<br>ETD has no beam control. |
| X-ray shifts missing in the<br>localized PDF printout | 151144 | In the localized (translated) pdf printout, no X-ray<br>shifts are printed. |
| PDF not created after treat | 154556 | PDF not created after treatment, wrongly created<br>with RepeatExport<br>Bug related to 153990 from testing of RC2 |
| Too many DRRs saved | 153990 | ETD saves 3 DRRs per X-ray Each DRR is 1MB<br>approx. This is a huge amount of data saved that<br>actually the users do not use but occupies hard disc<br>making the search of patient and loading a patient<br> |
| Surfaces are saved every<br>time the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-<br>of-tolerance (OOT) during patient monitoring, even if<br>only for a fraction of a second. |
| Crash during closing app in<br>Monitoring (after<br>SurfaceTrackingOutOfTolera<br>nceTreatmentEvent) | 154422<br>(Consequence out<br>of Bug 152130) | Crash when closing application in monitoring. |
| Crash during closing app in<br>Monitoring (during treatment<br>session saving) | 154423<br>(Consequence out<br>of Bug 152130) | Crash when closing application in monitoring. |
| Improve 'send shift'/'Go to<br>Treatment' behavior for<br>verification with excluded and<br>zeroed out big rotations in<br>ImplM WF | 151687 | In the implanted marker WF it is possible to exclude<br>big rotations and zero them out in surface tracking.<br>However, if the rotational shifts are higher than 5°,<br>they will always cause an 'Out of Tolerance' in<br>monitoring (even if they are excluded and zeroed<br>out), causing a beam hold event, which forces a<br>verification and sending a (minimal) shift is<br>always required to continue the treatment.<br>This causes many problems for Users that do have<br>an internal rule to always verify the position again<br>after the couch has been moved. |
| toplevelbips of ETD 1.1.2 do<br>not install all required<br>packages | 154327 | When performing a new installation using the ETD<br>toplevelbip the following bip packages are not<br>selected for installation |
| Upgrade ContentManager<br>2.7/2.8 with custom settings | 154333 | - |
| SW Crash on Sending Shift in<br>OAR Verification | 154385 | - |
| TC test: different reference<br>pictures because of different<br>fusion matrix | 154449 | - |
| Short name | Bugzilla ID | Description |
| Gantry angle based X-ray<br>triggered too early (Elekta) | 154093 | Gantry angle based X-ray is triggered too early for<br>Elekta. |
| Usergroup check is<br>performed on current user,<br>not user communicated by<br>PDM | 125826 | ETD uses Windows users instead of PDM users. |
| Patient deletion fails for<br>certain data sets | 152829 | - |
| Patient positioning based on<br>wrong isocenter possible in<br>Verification after Monitoring in<br>rare cases | 154002 | A Setup Beam that was scheduled for the previous<br>patient and was not used, however it was loaded at<br>the end of the treatment by an automatic function of<br>the Linac. Exactrac detected the beam loading at<br>the Linac and waited for user's confirmation.<br>Instead, the user closed the plan and the patient at<br>the Linac. ExacTrac software seems to expect no<br>plan closing event at the Linac while ETD is in<br>Monitoring. The user was informed via message that<br>"Beam has changed on the Linac" and confirmed it.<br>At this point the software could either crash or<br>proceed, presumably depending on the memory<br>state,<br>In case the software proceeds, the beam is loaded<br>and the user can proceed with the X-Ray<br>Verification. In this case the shift would be based on<br>the isocenter of the mistaken loaded beam, from the<br>previous patient. |
| Crash after X-ray acquisition<br>on X-ray Correction or<br>Acquisition page | 154035 | Crash after X-ray acquisition on X-ray Correction or<br>Acquisition page. |
| [DIBH] ETD Crashes when<br>clicking twice fast on "<br>Confirm level of today" | 148088 | By click twice fast on "Confirm Level of Today" the<br>software crash. |
| Wrong level of drawn Gating<br>Window in Frozen View of<br>DIBH Navigation | 148462 | Having acquired an X-ray in DIBH Navigation<br>causes the view to freeze. All information as<br>available in the point in time of X-ray acquisition is<br>visualized / summarized. |
| Too sensitive Couch<br>Movement Check for Elekta<br>Precise couches | 154087 | Too sensitive Couch Movement Check for Elekta<br>Precise couches in the DIBH workflow. |
| [PrePos] [DIBH]<br>Prepositioning fails after<br>DIBH treatment | 150403 | For every patient that is loaded on ETD immediately<br>after a DIBH treatment, the Prepositioning contour is<br>not shown. |
| ETD can treat despite<br>overdue Thermal to 3D<br>calibration | 150600 | Patients can be treated despite overdue thermal-to-<br>3D camera calibration in case the following<br>conditions are fulfilled: first treatment section of this<br>patient, unprepared patient, and first ETD patient of<br>the day. |
| Wrong x-ray shift for beams<br>with different PSA in<br>implanted marker monitoring | 150933 | Wrong x-ray shift in Monitoring for beams with<br>different PSA in implanted marker monitoring |
| Short name | Bugzilla ID | Description |
| Surfaces are saved every<br>time the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-<br>of-tolerance (OOT) during patient monitoring, even if<br>only for a fraction of a second. |
| Missed following automatic X-<br>ray trigger acquisition(s)<br>(counter-clockwise beam) | 154022 | first X-ray at 90° is triggered correctly when gantry is<br>at 96.9° following acquisitions (0° and 270°) are<br>missed, as the SW does not expect more<br>acquisitions beyond the gantry angle of 96.6° |
| Support Archiving Service | 154028 | Currently ETD applications are not supporting the<br>Archiving Proxy feature of archiving in a network<br>disk feature of the DICOMProxy. |
| Gantry angle based X-ray<br>was triggered too early | 154093 | Automatically gantry-triggered X-rays were acquired<br>too early due to one-time variations of the gantry<br>velocity. |
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There was no change of intended use, technological characteristics or typical users.
| Features | ExacTrac Dynamic 1.1 K220338<br>(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject<br>Device) | Comments |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indications<br>for Use | ExacTrac Dynamic is intended to<br>position patients at an accurately<br>defined point within the treatment<br>beam of a medical accelerator for<br>stereotactic radiosurgery or<br>radiotherapy procedures, to<br>monitor the patient position and to<br>provide a beam hold signal in case<br>of a deviations in order to treat<br>lesions, tumors and conditions<br>anywhere in the body when<br>radiation treatment is indicated. | ExacTrac Dynamic is intended to<br>position patients at an accurately<br>defined point within the treatment<br>beam of a medical accelerator for<br>stereotactic radiosurgery or<br>radiotherapy procedures, to<br>monitor the patient position and to<br>provide a beam hold signal in case<br>of a deviations in order to treat<br>lesions, tumors and conditions<br>anywhere in the body when<br>radiation treatment is indicated. | No<br>changes |
| Localization<br>technique | The camera detects both the<br>patient surface and the patient<br>thermal surface which together, can<br>be used to track the patient<br>geometries.<br>Stereo X-ray is acquired and<br>compared with the planned position<br>(room based).<br>CBCT data are imported from a<br>from 3rd party CBCT Device and<br>compared with the planned<br>position. | The camera detects both the<br>patient surface and the patient<br>thermal surface which together, can<br>be used to track the patient<br>geometries.<br>Stereo X-ray is acquired and<br>compared with the planned position<br>(room based).<br>CBCT data are imported from a<br>from 3rd party CBCT Device and<br>compared with the planned<br>position. | Same as<br>the<br>predicate<br>device. |
| Features | ExacTrac Dynamic 1.1 K220338<br>(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject<br>Device) | Comments |
| General<br>workflow:<br>Patient<br>preparation<br>before using<br>ExacTrac | Uses implanted radio opaque<br>fiducial markers or using Body<br>Markers Performing CT scan<br>Data import from treatment<br>planning system | Uses implanted radio opaque<br>fiducial markers or using Body<br>Markers Performing CT scan<br>Data import from treatment<br>planning system | Same<br>patient<br>preparation method<br>as the<br>predicate |
| Software<br>User<br>Management | Done via Windows user<br>management according to our<br>instructions | Done via Windows user<br>management according to our<br>instructions | Identical to<br>the<br>predicate |
| Deep<br>Inspiration<br>Breath-Hold<br>(DIBH) | ExacTrac Dynamic 1.1 features a<br>Deep Inspiration Breath-Hold<br>(DIBH) functionality to treat breast<br>cancer. This functionality includes<br>special features and workflows to<br>correctly position the patient to a<br>deep inspiration breath-hold<br>level and then to monitor this<br>position using the ExacTrac surface<br>tracking and x-ray positioning<br>technology. The aim of this<br>technology is to treat the patient<br>only during breath-hold phases<br>where the breast is at a defined<br>position with a maximum distance<br>to critical structures like the heart.<br>These feature results in an optional<br>use of the patient feedback system | ExacTrac Dynamic 1.1.2 features a<br>Deep Inspiration Breath-Hold<br>(DIBH) functionality to treat breast<br>cancer. This functionality includes<br>special features and workflows to<br>correctly position the patient to a<br>deep inspiration breath-hold<br>level and then to monitor this<br>position using the ExacTrac surface<br>tracking and x-ray positioning<br>technology. The aim of this<br>technology is to treat the patient<br>only during breath-hold phases<br>where the breast is at a defined<br>position with a maximum distance<br>to critical structures like the heart.<br>These feature results in an optional<br>use of the patient feedback system. | No change |
| Surface<br>Only | A separate workflow offers the<br>possibility to position the patient<br>with a third party positioning device<br>e.g. CBCT. The patient position<br>defined by the third party device<br>can be set as a reference for<br>ExacTrac Dynamic which allows<br>monitoring the patient using<br>ExacTracs surface camera and X-<br>ray system relative to this position.<br>ExacTrac Dynamic 1.1 shall offer<br>performing this third party<br>positioning and ExacTrac Dynamic<br>monitoring workflow by only using<br>the surface tracking system -<br>contrary to ExacTrac Dynamic 1.0<br>where it was necessary to acquire<br>X-ray images to set the third party<br>defined patient position as a<br>reference for ExacTrac Dynamic | A separate workflow offers the<br>possibility to position the patient<br>with a third party positioning device<br>e.g. CBCT. The patient position<br>defined by the third party device<br>can be set as a reference for<br>ExacTrac Dynamic which allows<br>monitoring the patient using<br>ExacTracs surface camera and X-<br>ray system relative to this position.<br>ExacTrac Dynamic 1.1.2 shall offer<br>performing this third party<br>positioning and ExacTrac Dynamic<br>monitoring workflow by only using<br>the surface tracking system. | No change |
| Features | ExacTrac Dynamic 1.1 K220338<br>(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject<br>Device) | Comments |
| ExacTrac<br>Console | ExacTrac Console (System<br>start/shut down, X-ray acquisition)<br>Image: ExacTrac Console | ExacTrac Console (System<br>start/shut down, X-ray acquisition)<br>Image: ExacTrac Console | No change |
| X-ray<br>Sources | Varex G-892 Sources (Housing:<br>Varex B-130) | Varex G-892 Sources (Housing:<br>Varex B-130) | No change |
| Flat Panel<br>Detector<br>including<br>Power<br>Supply | Flat Panel Detector<br>Varex PaxScan 3030DX | no change compared to predicate | No change |
| Cameras | 3D and Thermal Cameras<br>Manufacturer (3D): Cognex Ireland<br>Limited Type: A5060<br>Manufacturer (Thermal): Flir<br>Systems AB Type: A65 F25<br>Image: Camera<br>The camera is used to detect the<br>patient's thermal and spatial<br>surface. The thermal topology is<br>used to prevent the surface<br>registration algorithm from falling<br>into local minima. Thus both<br>surfaces are used to track patient's<br>position. | 3D and Thermal Cameras<br>Manufacturer (3D): Cognex Ireland<br>Limited Type: A5060<br>Manufacturer (Thermal): Flir<br>Systems AB Type: A65 F25<br>Image: Camera<br>The camera is used to detect the<br>patient's thermal and spatial<br>surface. The thermal topology is<br>used to prevent the surface<br>registration algorithm from falling<br>into local minima. Thus both<br>surfaces are used to track patient's<br>position. | no change |
| Features | ExacTrac Dynamic 1.1 K220338<br>(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject<br>Device) | Comments |
| Wall<br>mounted<br>Touch<br>Screen<br>Monitor | Image: ExacTrac Dynamic 1.1 K220338 | Image: ExacTrac Dynamic 1.1.2 | 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 |
| Patient<br>Feedback<br>System | The Patient Feedback System<br>helps patients visualize their own<br>respiration and to achieve a correct<br>breath hold.<br>Therefore the mirror is attached the<br>patient head and they can see the<br>in Room Monitor.<br>The Monitor shows a the live<br>respiratory status and the DIBH<br>Gating Window. The System is only<br>for supporting the patients, a<br>treatment without is also possible | The Patient Feedback System<br>helps patients visualize their own<br>respiration and to achieve a correct<br>breath hold.<br>Therefore the mirror is attached the<br>patient head and they can see the<br>in Room Monitor.<br>The Monitor shows a the live<br>respiratory status and the DIBH<br>Gating Window. The System is only<br>for supporting the patients, a<br>treatment without is also possible. | No<br>change. |
| Features | ExacTrac Dynamic 1.1 K220338<br>(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject<br>Device) | Comments |
| X-ray<br>Calibration | Image: X-ray Calibration…
