(28 days)
Not Found
No
The summary describes image processing and comparison for patient positioning and monitoring, but does not mention AI or ML. The modifications described are related to DIBH functionality and extended surface tracking, not AI/ML integration.
No.
The device is a patient positioning and monitoring system used in radiotherapy; it does not directly treat or cure disease.
No
The device is described as a "patient positioning device" used in radiotherapy to ensure accurate patient alignment for treatment. It helps to monitor and correct patient position but does not diagnose diseases or conditions.
No
The device description explicitly mentions hardware components like oblique x-ray images, a surface camera, and X-ray technology used for positioning and monitoring, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- ExacTrac Dynamic's Function: ExacTrac Dynamic is a patient positioning and monitoring device used during radiotherapy treatment. It uses imaging data (CT, X-ray, camera) to align the patient and ensure they remain in the correct position for radiation delivery. It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states its purpose is for "positioning patients... 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." This is a treatment support function, not a diagnostic function based on in vitro analysis.
Therefore, ExacTrac Dynamic falls under the category of a medical device used in a clinical setting for patient positioning and monitoring during radiotherapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
oblique x-ray images, CT data, CBCT data
Anatomical Site
anywhere in the body, breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExacTrac Dynamic 1.1 (K220338)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
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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
2
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 Suresh |
| QM Consultant, Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| 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
4
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 beam | ||
| hold control – Amiens | ||
| (Case-20221124- |
- | Bug 154505 | In the Treatment application it is possible to treat
a DIBH patient with disabled beam control, i.e. if
a DIBH plan is prepared with disabled beam
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 | ||
| although archiving proxy is | ||
| configured | 155619 | it is not possible to delete patient without previously |
| have pressed archive button although the data is | ||
| already archived automatically through the | ||
| implementation of the bug 154028. | ||
| Possibility to achieve | ||
| Monitoring having positioned | ||
| with a setup beam which has | ||
| different isocenter | 155252 | For plans containing an additional setup beam with |
| a "virtual" isocenter, i.e. an isocenter different than | ||
| the isocenter of the treatment beam, it is possible to | ||
| position and treat the patient on the virtual isocenter | ||
| instead on the treatment isocenter. | ||
| Short name | Bugzilla ID | Description |
| There is a wrong | ||
| dependency/rule that | ||
| excludes ContentManager | ||
| 2.8 | 155034 | Wrong dependency in the top level package |
| DIBH procedure without | ||
| beam hold control – Amiens | ||
| (Case-20221124-451154) | 154506 | In the Template Editor it is possible to prepare a |
| DIBH template with disabled beam control, i.e. that | ||
| ETD has no beam control. | ||
| X-ray shifts missing in the | ||
| localized PDF printout | 151144 | In the localized (translated) pdf printout, no X-ray |
| shifts are printed. | ||
| PDF not created after treat | 154556 | PDF not created after treatment, wrongly created |
| with RepeatExport | ||
| Bug related to 153990 from testing of RC2 | ||
| Too many DRRs saved | 153990 | ETD saves 3 DRRs per X-ray Each DRR is 1MB |
| approx. This is a huge amount of data saved that | ||
| actually the users do not use but occupies hard disc | ||
| making the search of patient and loading a patient |
|
| Surfaces are saved every
time the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-
of-tolerance (OOT) during patient monitoring, even if
only for a fraction of a second. |
| Crash during closing app in
Monitoring (after
SurfaceTrackingOutOfTolera
nceTreatmentEvent) | 154422
(Consequence out
of Bug 152130) | Crash when closing application in monitoring. |
| Crash during closing app in
Monitoring (during treatment
session saving) | 154423
(Consequence out
of Bug 152130) | Crash when closing application in monitoring. |
| Improve 'send shift'/'Go to
Treatment' behavior for
verification with excluded and
zeroed out big rotations in
ImplM WF | 151687 | In the implanted marker WF it is possible to exclude
big 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' in
monitoring (even if they are excluded and zeroed
out), causing a beam hold event, which forces a
verification and sending a (minimal) shift is
always required to continue the treatment.
This causes many problems for Users that do have
an internal rule to always verify the position again
after the couch has been moved. |
| toplevelbips of ETD 1.1.2 do
not install all required
packages | 154327 | When performing a new installation using the ETD
toplevelbip the following bip packages are not
selected for installation |
| Upgrade ContentManager
2.7/2.8 with custom settings | 154333 | - |
| SW Crash on Sending Shift in
OAR Verification | 154385 | - |
| TC test: different reference
pictures because of different
fusion matrix | 154449 | - |
| Short name | Bugzilla ID | Description |
| Gantry angle based X-ray
triggered too early (Elekta) | 154093 | Gantry angle based X-ray is triggered too early for
Elekta. |
| Usergroup check is
performed on current user,
not user communicated by
PDM | 125826 | ETD uses Windows users instead of PDM users. |
| Patient deletion fails for
certain data sets | 152829 | - |
| Patient positioning based on
wrong isocenter possible in
Verification after Monitoring in
rare cases | 154002 | A Setup Beam that was scheduled for the previous
patient and was not used, however it was loaded at
the end of the treatment by an automatic function of
the Linac. Exactrac detected the beam loading at
the Linac and waited for user's confirmation.
Instead, the user closed the plan and the patient at
the Linac. ExacTrac software seems to expect no
plan closing event at the Linac while ETD is in
Monitoring. The user was informed via message that
"Beam has changed on the Linac" and confirmed it.
At this point the software could either crash or
proceed, presumably depending on the memory
state,
In case the software proceeds, the beam is loaded
and the user can proceed with the X-Ray
Verification. In this case the shift would be based on
the isocenter of the mistaken loaded beam, from the
previous patient. |
| Crash after X-ray acquisition
on X-ray Correction or
Acquisition page | 154035 | Crash after X-ray acquisition on X-ray Correction or
Acquisition page. |
| [DIBH] ETD Crashes when
clicking twice fast on "
Confirm level of today" | 148088 | By click twice fast on "Confirm Level of Today" the
software crash. |
| Wrong level of drawn Gating
Window in Frozen View of
DIBH Navigation | 148462 | Having acquired an X-ray in DIBH Navigation
causes the view to freeze. All information as
available in the point in time of X-ray acquisition is
visualized / summarized. |
| Too sensitive Couch
Movement Check for Elekta
Precise couches | 154087 | Too sensitive Couch Movement Check for Elekta
Precise couches in the DIBH workflow. |
| [PrePos] [DIBH]
Prepositioning fails after
DIBH treatment | 150403 | For every patient that is loaded on ETD immediately
after a DIBH treatment, the Prepositioning contour is
not shown. |
| ETD can treat despite
overdue Thermal to 3D
calibration | 150600 | Patients can be treated despite overdue thermal-to-
3D camera calibration in case the following
conditions are fulfilled: first treatment section of this
patient, unprepared patient, and first ETD patient of
the day. |
| Wrong x-ray shift for beams
with different PSA in
implanted marker monitoring | 150933 | Wrong x-ray shift in Monitoring for beams with
different PSA in implanted marker monitoring |
| Short name | Bugzilla ID | Description |
| Surfaces are saved every
time the surface goes OoT | 152130 | Surfaces are saved every time the surface goes out-
of-tolerance (OOT) during patient monitoring, even if
only 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 is
at 96.9° following acquisitions (0° and 270°) are
missed, as the SW does not expect more
acquisitions beyond the gantry angle of 96.6° |
| Support Archiving Service | 154028 | Currently ETD applications are not supporting the
Archiving Proxy feature of archiving in a network
disk feature of the DICOMProxy. |
| Gantry angle based X-ray
was triggered too early | 154093 | Automatically gantry-triggered X-rays were acquired
too early due to one-time variations of the gantry
velocity. |
5
6
7
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 (Subject
Device) | Comments |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 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 deviations in order to treat
lesions, tumors and conditions
anywhere in the body when
radiation treatment is indicated. | 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 deviations in order to treat
lesions, tumors and conditions
anywhere in the body when
radiation treatment is indicated. | No
changes |
| Localization
technique | The camera detects both the
patient surface and the patient
thermal surface which together, can
be used to track the patient
geometries.
Stereo X-ray is acquired and
compared with the planned position
(room based).
CBCT data are imported from a
from 3rd party CBCT Device and
compared with the planned
position. | The camera detects both the
patient surface and the patient
thermal surface which together, can
be used to track the patient
geometries.
Stereo X-ray is acquired and
compared with the planned position
(room based).
CBCT data are imported from a
from 3rd party CBCT Device and
compared with the planned
position. | Same as
the
predicate
device. |
| Features | ExacTrac Dynamic 1.1 K220338
(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject
Device) | Comments |
| General
workflow:
Patient
preparation
before using
ExacTrac | Uses implanted radio opaque
fiducial markers or using Body
Markers Performing CT scan
Data import from treatment
planning system | Uses implanted radio opaque
fiducial markers or using Body
Markers Performing CT scan
Data import from treatment
planning system | Same
patient
preparation method
as the
predicate |
| Software
User
Management | Done via Windows user
management according to our
instructions | Done via Windows user
management according to our
instructions | Identical to
the
predicate |
| Deep
Inspiration
Breath-Hold
(DIBH) | ExacTrac Dynamic 1.1 features a
Deep Inspiration Breath-Hold
(DIBH) functionality to treat breast
cancer. This functionality includes
special features and workflows to
correctly position the patient to a
deep inspiration breath-hold
level and then to monitor this
position using the ExacTrac 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.
These feature results in an optional
use of the patient feedback system | ExacTrac Dynamic 1.1.2 features a
Deep Inspiration Breath-Hold
(DIBH) functionality to treat breast
cancer. This functionality includes
special features and workflows to
correctly position the patient to a
deep inspiration breath-hold
level and then to monitor this
position using the ExacTrac 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.
These feature results in an optional
use of the patient feedback system. | No change |
| Surface
Only | A separate workflow offers the
possibility to position the patient
with a third party positioning device
e.g. CBCT. The patient position
defined by the third party device
can be set as a reference for
ExacTrac Dynamic which allows
monitoring the patient using
ExacTracs surface camera and X-
ray system relative to this position.
ExacTrac Dynamic 1.1 shall offer
performing this third party
positioning and ExacTrac Dynamic
monitoring workflow by only using
the surface tracking system -
contrary to ExacTrac Dynamic 1.0
where it was necessary to acquire
X-ray images to set the third party
defined patient position as a
reference for ExacTrac Dynamic | A separate workflow offers the
possibility to position the patient
with a third party positioning device
e.g. CBCT. The patient position
defined by the third party device
can be set as a reference for
ExacTrac Dynamic which allows
monitoring the patient using
ExacTracs surface camera and X-
ray system relative to this position.
ExacTrac Dynamic 1.1.2 shall offer
performing this third party
positioning and ExacTrac Dynamic
monitoring workflow by only using
the surface tracking system. | No change |
| Features | ExacTrac Dynamic 1.1 K220338
(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject
Device) | Comments |
| ExacTrac
Console | ExacTrac Console (System
start/shut down, X-ray acquisition)
Image: ExacTrac Console | ExacTrac Console (System
start/shut down, X-ray acquisition)
Image: ExacTrac 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
Detector
including
Power
Supply | Flat Panel Detector
Varex PaxScan 3030DX | no change compared to predicate | No change |
| Cameras | 3D and Thermal Cameras
Manufacturer (3D): Cognex Ireland
Limited Type: A5060
Manufacturer (Thermal): Flir
Systems AB Type: A65 F25
Image: Camera
The camera is used to detect the
patient's thermal and spatial
surface. The thermal topology is
used to prevent the surface
registration algorithm from falling
into local minima. Thus both
surfaces are used to track patient's
position. | 3D and Thermal Cameras
Manufacturer (3D): Cognex Ireland
Limited Type: A5060
Manufacturer (Thermal): Flir
Systems AB Type: A65 F25
Image: Camera
The camera is used to detect the
patient's thermal and spatial
surface. The thermal topology is
used to prevent the surface
registration algorithm from falling
into local minima. Thus both
surfaces are used to track patient's
position. | no change |
| Features | ExacTrac Dynamic 1.1 K220338
(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject
Device) | Comments |
| Wall
mounted
Touch
Screen
Monitor | Image: ExacTrac Dynamic 1.1 K220338 | Image: ExacTrac Dynamic 1.1.2 | No change |
| On Floor X-
ray sources
covers | X-ray tubes within On-Floor Boxes
X-ray Tubes within Floor | X-ray tubes within On-Floor Boxes
X-ray Tubes within Floor | No change |
| Patient
Feedback
System | The Patient Feedback System
helps patients visualize their own
respiration and to achieve a correct
breath hold.
Therefore the mirror is attached the
patient head and they can see the
in Room Monitor.
The Monitor shows a the live
respiratory status and the DIBH
Gating Window. The System is only
for supporting the patients, a
treatment without is also possible | The Patient Feedback System
helps patients visualize their own
respiration and to achieve a correct
breath hold.
Therefore the mirror is attached the
patient head and they can see the
in Room Monitor.
The Monitor shows a the live
respiratory status and the DIBH
Gating Window. The System is only
for supporting the patients, a
treatment without is also possible. | No
change. |
| Features | ExacTrac Dynamic 1.1 K220338
(Primary Predicate) | ExacTrac Dynamic 1.1.2 (Subject
Device) | Comments |
| X-ray
Calibration | Image: X-ray Calibration | Image: X-ray Calibration | No change |
| Camera
Calibration | Thermal to 3D Calibration Phantom
A phantom to calibrate the 3D
camera and the thermal camera
added. | Thermal to 3D Calibration Phantom
A phantom to calibrate the 3D
camera and the thermal camera
added. | No change |
Table 2: Comparison between the Subject Device and Predicate
8
9
10
11