(28 days)
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.
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 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.
The provided text describes a 510(k) premarket notification for the Brainlab AG ExacTrac Dynamic (1.1.2) device. This submission outlines that the device is a modification of a previously cleared predicate device (ExacTrac Dynamic 1.1) and primarily focuses on addressing identified software bugs and extending existing functionality (Deep Inspiration Breath-Hold and surface tracking).
Crucially, the document states: "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."
It also explicitly states: "The bug fix did not require any change to the existing software architecture." and "There was no change of intended use, technological characteristics or typical users."
Therefore, the information required to fully answer your request (acceptance criteria and a study that proves the device meets the acceptance criteria, as detailed in your bullet points) is largely absent from this 510(k) summary.
This type of 510(k) submission, focused on minor software modifications (bug fixes) to an already cleared device, typically relies on verification and validation (V&V) testing to demonstrate that the bug fixes have been successfully implemented and have not introduced new issues or adversely affected existing functionalities. It does not typically involve the kind of extensive clinical performance study (like an MRMC study with human readers, or a standalone algorithm performance study with a large, adjudicated test set) that would be conducted for a new AI/ML-driven diagnostic device or a device with significant functional changes.
Here's an analysis based on the provided text, highlighting what is missing:
Absence of Clinical Performance Study Details:
The document explicitly states that the modifications were "verified via incremental tests" and that "All tests were passed." This indicates a focus on engineering and software testing rather than a clinical performance study involving human readers or a large-scale, algorithm-only performance study against clinical ground truth. The acceptance criteria described are implicitly tied to the successful resolution of the identified bugs and the continued proper functioning of the device features.
The document lists numerous bug fixes, primarily concerning software behavior, data handling, and specific use case scenarios (e.g., DIBH beam control, patient deletion, X-ray triggering). The "performance data" section (Section 3) is very brief and refers back to the bug fixes and incremental tests rather than presenting a detailed study.
Detailed Breakdown of Missing Information as per your Request:
Given the nature of this 510(k) for bug fixes, many of your requested points are not applicable or the information is not present in the provided document.
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly laid out in a table in the provided text. The implicit acceptance criteria are that the bug fixes resolve the identified issues and that other functionalities remain unaffected and continue to meet their original design specifications.
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or precise shift measurements) are reported. The performance is implied by the passing of "incremental tests" for the bug fixes.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. "Incremental tests" suggest a focused set of tests for each bug, likely using synthetic data or a limited set of real-world scenarios to reproduce and verify the fix for each bug. This is not a "test set" in the sense of a large, independent clinical dataset.
- Data Provenance: Not specified. Given this is a software update for an existing device, the testing would likely involve internal company testing environments.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts/Qualifications: Not applicable and not mentioned. The "ground truth" for bug fixes is the correct software behavior as defined by the design specifications and user requirements, not a clinical diagnosis established by experts.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is for establishing ground truth in clinical image interpretation studies, not for software bug verification.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This type of study focuses on clinical benefit and human-AI interaction for diagnostic or interpretive tasks. ExacTrac Dynamic is a patient positioning and monitoring system for radiation therapy, not a diagnostic imaging AI. The changes here are bug fixes, not enhancements that would directly impact a human reader's diagnostic performance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No quantitative standalone performance data is presented in the context of clinical metrics (e.g., accuracy of positioning, false positives/negatives for beam hold signals). The "performance data" refers to the successful passing of internal verification tests for bug fixes.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Type of Ground Truth: For bug fixes, the "ground truth" is the predefined correct behavior of the software feature according to its specifications. This is established during the software development and design phase, not through external clinical adjudication.
-
The sample size for the training set:
- Training Set Sample Size: Not applicable and not mentioned. This device (or this specific update) does not describe using machine learning models that require a "training set" in the typical sense of AI/ML development for image analysis. The "Deep Inspiration Breath-Hold" functionality and "surface tracking" are described as features, but the document does not indicate that new ML models were trained as part of this specific update. The changes are described as "bug fixes" and "modified specifications."
-
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there's no mention of a training set for machine learning.
Conclusion:
This 510(k) summary for ExacTrac Dynamic (1.1.2) is a "minor change" submission focusing on software bug fixes to an already cleared predicate device. It explicitly highlights that there were no changes to the intended use, technological characteristics, or typical users. As such, the supporting documentation provided in the snippet is consistent with the type of verification and validation (V&V) typically conducted for such modifications, which relies on internal engineering and software testing ("incremental tests") to ensure the fixes are effective and do not introduce new issues, rather than large-scale clinical performance studies. Therefore, the detailed information requested regarding clinical study design, sample sizes, expert ground truth, and AI/ML training is not present in this particular FDA submission document snippet.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
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 SureshQM Consultant, Regulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com |
| Alternate Contact | Chiara CunicoSenior Manager Regulatory AffairsPhone: +49 89 99 15 68 0Email: 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 /Specification | Bugzilla ID | Description |
|---|---|---|
| procedure without beamhold control – Amiens(Case-20221124-451154) | Bug 154505 | In the Treatment application it is possible to treata DIBH patient with disabled beam control, i.e. ifa DIBH plan is prepared with disabled beamcontrol, 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 possiblealthough archiving proxy isconfigured | 155619 | it is not possible to delete patient without previouslyhave pressed archive button although the data isalready archived automatically through theimplementation of the bug 154028. |
| Possibility to achieveMonitoring having positionedwith a setup beam which hasdifferent isocenter | 155252 | For plans containing an additional setup beam witha "virtual" isocenter, i.e. an isocenter different thanthe isocenter of the treatment beam, it is possible toposition and treat the patient on the virtual isocenterinstead on the treatment isocenter. |
| Short name | Bugzilla ID | Description |
| There is a wrongdependency/rule thatexcludes ContentManager2.8 | 155034 | Wrong dependency in the top level package |
| DIBH procedure withoutbeam hold control – Amiens(Case-20221124-451154) | 154506 | In the Template Editor it is possible to prepare aDIBH template with disabled beam control, i.e. thatETD has no beam control. |
| X-ray shifts missing in thelocalized PDF printout | 151144 | In the localized (translated) pdf printout, no X-rayshifts are printed. |
| PDF not created after treat | 154556 | PDF not created after treatment, wrongly createdwith RepeatExportBug related to 153990 from testing of RC2 |
| Too many DRRs saved | 153990 | ETD saves 3 DRRs per X-ray Each DRR is 1MBapprox. This is a huge amount of data saved thatactually the users do not use but occupies hard discmaking the search of patient and loading a patient |
| Surfaces are saved everytime the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-of-tolerance (OOT) during patient monitoring, even ifonly for a fraction of a second. |
| Crash during closing app inMonitoring (afterSurfaceTrackingOutOfToleranceTreatmentEvent) | 154422(Consequence outof Bug 152130) | Crash when closing application in monitoring. |
| Crash during closing app inMonitoring (during treatmentsession saving) | 154423(Consequence outof Bug 152130) | Crash when closing application in monitoring. |
| Improve 'send shift'/'Go toTreatment' behavior forverification with excluded andzeroed out big rotations inImplM WF | 151687 | In the implanted marker WF it is possible to excludebig rotations and zero them out in surface tracking.However, if the rotational shifts are higher than 5°,they will always cause an 'Out of Tolerance' inmonitoring (even if they are excluded and zeroedout), causing a beam hold event, which forces averification and sending a (minimal) shift isalways required to continue the treatment.This causes many problems for Users that do havean internal rule to always verify the position againafter the couch has been moved. |
| toplevelbips of ETD 1.1.2 donot install all requiredpackages | 154327 | When performing a new installation using the ETDtoplevelbip the following bip packages are notselected for installation |
| Upgrade ContentManager2.7/2.8 with custom settings | 154333 | - |
| SW Crash on Sending Shift inOAR Verification | 154385 | - |
| TC test: different referencepictures because of differentfusion matrix | 154449 | - |
| Short name | Bugzilla ID | Description |
| Gantry angle based X-raytriggered too early (Elekta) | 154093 | Gantry angle based X-ray is triggered too early forElekta. |
| Usergroup check isperformed on current user,not user communicated byPDM | 125826 | ETD uses Windows users instead of PDM users. |
| Patient deletion fails forcertain data sets | 152829 | - |
| Patient positioning based onwrong isocenter possible inVerification after Monitoring inrare cases | 154002 | A Setup Beam that was scheduled for the previouspatient and was not used, however it was loaded atthe end of the treatment by an automatic function ofthe Linac. Exactrac detected the beam loading atthe Linac and waited for user's confirmation.Instead, the user closed the plan and the patient atthe Linac. ExacTrac software seems to expect noplan closing event at the Linac while ETD is inMonitoring. The user was informed via message that"Beam has changed on the Linac" and confirmed it.At this point the software could either crash orproceed, presumably depending on the memorystate,In case the software proceeds, the beam is loadedand the user can proceed with the X-RayVerification. In this case the shift would be based onthe isocenter of the mistaken loaded beam, from theprevious patient. |
| Crash after X-ray acquisitionon X-ray Correction orAcquisition page | 154035 | Crash after X-ray acquisition on X-ray Correction orAcquisition page. |
| [DIBH] ETD Crashes whenclicking twice fast on "Confirm level of today" | 148088 | By click twice fast on "Confirm Level of Today" thesoftware crash. |
| Wrong level of drawn GatingWindow in Frozen View ofDIBH Navigation | 148462 | Having acquired an X-ray in DIBH Navigationcauses the view to freeze. All information asavailable in the point in time of X-ray acquisition isvisualized / summarized. |
| Too sensitive CouchMovement Check for ElektaPrecise couches | 154087 | Too sensitive Couch Movement Check for ElektaPrecise couches in the DIBH workflow. |
| [PrePos] [DIBH]Prepositioning fails afterDIBH treatment | 150403 | For every patient that is loaded on ETD immediatelyafter a DIBH treatment, the Prepositioning contour isnot shown. |
| ETD can treat despiteoverdue Thermal to 3Dcalibration | 150600 | Patients can be treated despite overdue thermal-to-3D camera calibration in case the followingconditions are fulfilled: first treatment section of thispatient, unprepared patient, and first ETD patient ofthe day. |
| Wrong x-ray shift for beamswith different PSA inimplanted marker monitoring | 150933 | Wrong x-ray shift in Monitoring for beams withdifferent PSA in implanted marker monitoring |
| Short name | Bugzilla ID | Description |
| Surfaces are saved everytime the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-of-tolerance (OOT) during patient monitoring, even ifonly for a fraction of a second. |
| Missed following automatic X-ray trigger acquisition(s)(counter-clockwise beam) | 154022 | first X-ray at 90° is triggered correctly when gantry isat 96.9° following acquisitions (0° and 270°) aremissed, as the SW does not expect moreacquisitions beyond the gantry angle of 96.6° |
| Support Archiving Service | 154028 | Currently ETD applications are not supporting theArchiving Proxy feature of archiving in a networkdisk feature of the DICOMProxy. |
| Gantry angle based X-raywas triggered too early | 154093 | Automatically gantry-triggered X-rays were acquiredtoo early due to one-time variations of the gantryvelocity. |
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There was no change of intended use, technological characteristics or typical users.
| Features | ExacTrac Dynamic 1.1 K220338(Primary Predicate) | ExacTrac Dynamic 1.1.2 (SubjectDevice) | Comments |
|---|---|---|---|
| Indicationsfor Use | ExacTrac Dynamic is intended toposition patients at an accuratelydefined point within the treatmentbeam of a medical accelerator forstereotactic radiosurgery orradiotherapy procedures, tomonitor the patient position and toprovide a beam hold signal in caseof a deviations in order to treatlesions, tumors and conditionsanywhere in the body whenradiation treatment is indicated. | ExacTrac Dynamic is intended toposition patients at an accuratelydefined point within the treatmentbeam of a medical accelerator forstereotactic radiosurgery orradiotherapy procedures, tomonitor the patient position and toprovide a beam hold signal in caseof a deviations in order to treatlesions, tumors and conditionsanywhere in the body whenradiation treatment is indicated. | Nochanges |
| Localizationtechnique | The camera detects both thepatient surface and the patientthermal surface which together, canbe used to track the patientgeometries.Stereo X-ray is acquired andcompared with the planned position(room based).CBCT data are imported from afrom 3rd party CBCT Device andcompared with the plannedposition. | The camera detects both thepatient surface and the patientthermal surface which together, canbe used to track the patientgeometries.Stereo X-ray is acquired andcompared with the planned position(room based).CBCT data are imported from afrom 3rd party CBCT Device andcompared with the plannedposition. | Same asthepredicatedevice. |
| Features | ExacTrac Dynamic 1.1 K220338(Primary Predicate) | ExacTrac Dynamic 1.1.2 (SubjectDevice) | Comments |
| Generalworkflow:Patientpreparationbefore usingExacTrac | Uses implanted radio opaquefiducial markers or using BodyMarkers Performing CT scanData import from treatmentplanning system | Uses implanted radio opaquefiducial markers or using BodyMarkers Performing CT scanData import from treatmentplanning system | Samepatientpreparation methodas thepredicate |
| SoftwareUserManagement | Done via Windows usermanagement according to ourinstructions | Done via Windows usermanagement according to ourinstructions | Identical tothepredicate |
| DeepInspirationBreath-Hold(DIBH) | ExacTrac Dynamic 1.1 features aDeep Inspiration Breath-Hold(DIBH) functionality to treat breastcancer. This functionality includesspecial features and workflows tocorrectly position the patient to adeep inspiration breath-holdlevel and then to monitor thisposition using the ExacTrac surfacetracking and x-ray positioningtechnology. The aim of thistechnology is to treat the patientonly during breath-hold phaseswhere the breast is at a definedposition with a maximum distanceto critical structures like the heart.These feature results in an optionaluse of the patient feedback system | ExacTrac Dynamic 1.1.2 features aDeep Inspiration Breath-Hold(DIBH) functionality to treat breastcancer. This functionality includesspecial features and workflows tocorrectly position the patient to adeep inspiration breath-holdlevel and then to monitor thisposition using the ExacTrac surfacetracking and x-ray positioningtechnology. The aim of thistechnology is to treat the patientonly during breath-hold phaseswhere the breast is at a definedposition with a maximum distanceto critical structures like the heart.These feature results in an optionaluse of the patient feedback system. | No change |
| SurfaceOnly | A separate workflow offers thepossibility to position the patientwith a third party positioning devicee.g. CBCT. The patient positiondefined by the third party devicecan be set as a reference forExacTrac Dynamic which allowsmonitoring the patient usingExacTracs surface camera and X-ray system relative to this position.ExacTrac Dynamic 1.1 shall offerperforming this third partypositioning and ExacTrac Dynamicmonitoring workflow by only usingthe surface tracking system -contrary to ExacTrac Dynamic 1.0where it was necessary to acquireX-ray images to set the third partydefined patient position as areference for ExacTrac Dynamic | A separate workflow offers thepossibility to position the patientwith a third party positioning devicee.g. CBCT. The patient positiondefined by the third party devicecan be set as a reference forExacTrac Dynamic which allowsmonitoring the patient usingExacTracs surface camera and X-ray system relative to this position.ExacTrac Dynamic 1.1.2 shall offerperforming this third partypositioning and ExacTrac Dynamicmonitoring workflow by only usingthe surface tracking system. | No change |
| Features | ExacTrac Dynamic 1.1 K220338(Primary Predicate) | ExacTrac Dynamic 1.1.2 (SubjectDevice) | Comments |
| ExacTracConsole | ExacTrac Console (Systemstart/shut down, X-ray acquisition)Image: ExacTrac Console | ExacTrac Console (Systemstart/shut down, X-ray acquisition)Image: ExacTrac Console | No change |
| X-raySources | Varex G-892 Sources (Housing:Varex B-130) | Varex G-892 Sources (Housing:Varex B-130) | No change |
| Flat PanelDetectorincludingPowerSupply | Flat Panel DetectorVarex PaxScan 3030DX | no change compared to predicate | No change |
| Cameras | 3D and Thermal CamerasManufacturer (3D): Cognex IrelandLimited Type: A5060Manufacturer (Thermal): FlirSystems AB Type: A65 F25Image: CameraThe camera is used to detect thepatient's thermal and spatialsurface. The thermal topology isused to prevent the surfaceregistration algorithm from fallinginto local minima. Thus bothsurfaces are used to track patient'sposition. | 3D and Thermal CamerasManufacturer (3D): Cognex IrelandLimited Type: A5060Manufacturer (Thermal): FlirSystems AB Type: A65 F25Image: CameraThe camera is used to detect thepatient's thermal and spatialsurface. The thermal topology isused to prevent the surfaceregistration algorithm from fallinginto local minima. Thus bothsurfaces are used to track patient'sposition. | no change |
| Features | ExacTrac Dynamic 1.1 K220338(Primary Predicate) | ExacTrac Dynamic 1.1.2 (SubjectDevice) | Comments |
| WallmountedTouchScreenMonitor | Image: ExacTrac Dynamic 1.1 K220338 | Image: ExacTrac Dynamic 1.1.2 | No change |
| On Floor X-ray sourcescovers | X-ray tubes within On-Floor BoxesX-ray Tubes within Floor | X-ray tubes within On-Floor BoxesX-ray Tubes within Floor | No change |
| PatientFeedbackSystem | The Patient Feedback Systemhelps patients visualize their ownrespiration and to achieve a correctbreath hold.Therefore the mirror is attached thepatient head and they can see thein Room Monitor.The Monitor shows a the liverespiratory status and the DIBHGating Window. The System is onlyfor supporting the patients, atreatment without is also possible | The Patient Feedback Systemhelps patients visualize their ownrespiration and to achieve a correctbreath hold.Therefore the mirror is attached thepatient head and they can see thein Room Monitor.The Monitor shows a the liverespiratory status and the DIBHGating Window. The System is onlyfor supporting the patients, atreatment without is also possible. | Nochange. |
| Features | ExacTrac Dynamic 1.1 K220338(Primary Predicate) | ExacTrac Dynamic 1.1.2 (SubjectDevice) | Comments |
| X-rayCalibration | Image: X-ray Calibration | Image: X-ray Calibration | No change |
| CameraCalibration | Thermal to 3D Calibration PhantomA phantom to calibrate the 3Dcamera and the thermal cameraadded. | Thermal to 3D Calibration PhantomA phantom to calibrate the 3Dcamera and the thermal cameraadded. | No change |
Table 2: Comparison between the Subject Device and Predicate
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.