(81 days)
Not Found
No
The summary describes image processing and patient positioning techniques but does not mention AI or ML. The performance studies and key metrics are standard for medical devices and do not indicate the use of AI/ML.
No.
The device is a patient positioning and monitoring system for radiotherapy, it does not directly treat or diagnose diseases but rather aids in the precise delivery of therapeutic radiation.
No
This device is intended for patient positioning and monitoring during radiotherapy, not for diagnosing medical conditions. It uses imaging to ensure accurate treatment delivery, not to identify or characterize disease.
No
The device description explicitly states it uses oblique x-ray images, a surface camera, and X-ray technology for positioning and monitoring, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "positioning 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". This describes a device used on the patient during a medical procedure, not a device used to test samples from the patient (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description details how the device uses imaging (x-ray, surface camera) to determine and monitor the patient's position relative to a treatment beam. This is consistent with a patient positioning and monitoring system for radiotherapy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
In summary, ExacTrac Dynamic is a medical device used for patient positioning and monitoring during radiotherapy, which falls outside the definition of 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 is a modification of the previously cleared device ExacTrac Dynamic 1.0 that additionally features a Deep Inspiration Breath-Hold (DIBH) functionality to treat breast cancer. This functionality helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology. This functionality was not included in ExacTrac Dynamic 1.0. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined position with a maximum distance to critical structures like the heart. Additionally, the surface tracking functionality was extended, which monitors the patient after an initial 3rd party positioning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
oblique x-ray images, CT data, 3D surface imaging, CBCT data
Anatomical Site
Anywhere in the body (for radiation treatment), specifically breast (for DIBH)
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
Study population: 13 female subjects.
The first study population (patient population), consisted of subjects who are women who were diagnosed with breast cancer that is indicated for a treatment with radiation therapy with the DIBH technique and who are currently, or who have currently been treated with this technique.
The second study population (volunteer population) consisted of subjects who are healthy women who resembled patients that are typically diagnosed with breast cancer as far as possible, concerning their physiognomy and age, and who can perform sufficiently deep and long DIBHs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- . Compatibility Tests:
- Cybersecurity Tests:
- o ETD Pen Test
- o Vulnerability Test
- . Accuracy Test: The test objective is to verify that accuracy specifications for positioning and monitoring of ExacTrac Dynamic are not affected by the selected workflow, treatment parameters and different phantom positions. Also, within this test plan the correct display of deviation indicators and X-ray/DRR overlays as well as the correct transfer and adjustment of shifts and rotations to the patient support system.
- . Biological Evaluation: It examines the materials used in the device, considers the application of biological and chemical tests, and the history of safety and efficacy of the device materials in humans.
- . Usability Evaluation
- Routine Software verification to confirm that the specifications met the requirements
Clinical Validation: For the new feature, a clinical evaluation was performed which was based on literature review, performance evaluation on phantoms and a clinical investigation for DIBH.
Overview of the Pre-market, single-center Clinical Investigation: Since the functionality to generate a respiratory signal is new to the Subject Device, a clinical investigation was performed to evaluate the surface camera system-based components of the ETD DIBH module.
Study Objectives: -
- ETD can assist a human eligible for DIBH (Paul Keall, 2006) to reproduce a defined state of deep inspiration breath-hold (DIBH) within +/- 3 mm.
-
- Regarding the pre-positioning within the DIBH workflow based on ETD's 3D' surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.
Key results: All acceptance criteria for the successful completion of the study were passed. No adverse events or adverse device deficiencies were observed.
- Regarding the pre-positioning within the DIBH workflow based on ETD's 3D' surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExacTrac Dynamic (K201276)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainlab AG % Chiara Cunico Manager RA Olof-Palme-Str. 9 Munich, 81829 GERMANY
Re: K220338
Trade/Device Name: ExacTrac Dynamic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 3, 2022 Received: February 18, 2022
Dear Chiara Cunico:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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,
Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
ExacTrac Dynamic (1.1)
Indications for Use (Describe)
ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is an abstract design featuring a pattern of interconnected triangles. The triangles vary in size and are filled with different shades of blue, creating a gradient effect from darker to lighter hues. The overall composition gives a sense of geometric complexity and visual depth.
Image /page/3/Picture/1 description: The image shows the logo for Brainlab. The logo consists of a stylized symbol to the left of the word "BRAINLAB" in all capital letters. The symbol appears to be a stylized representation of the brain. The text is in a bold, sans-serif font.
510(k) Summary
April 22, 2022
| 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 |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Devices | ExacTrac Dynamic (K201276) |
1. Indications for Use
ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
2. Device Description
ExacTrac Dynamic is a patient positioning device used in a radiotherapy environment as an addon system to standard linear accelerators. It uses patient planning and CT data to determine the patient's planned position and compares it via oblique x-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment is monitored with a surface camera and X-ray to ensure no misalignment due to patient movement.
ExacTrac Dynamic 1.1 is a modification of the previously cleared device ExacTrac Dynamic 1.0 that additionally features a Deep Inspiration Breath-Hold (DIBH) functionality to treat breast cancer. This functionality helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology. This functionality was not included in ExacTrac Dynamic 1.0. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined position with a maximum distance to critical structures like the heart. Additionally, the surface tracking functionality was extended, which monitors the patient after an initial 3rd party positioning.
3. Substantial Equivalence
4
| Features | ExacTrac Dynamic 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (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. |
| 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 |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| Deep
Inspiration
Breath-Hold
(DIBH) | N/A | 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. | New feature added |
| Surface Only | N/A | Additionally, 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 ExacTrac's
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 | New feature added |
| X-ray
Generator | The X-ray Generator consists of two HFe 601 X-
ray Generators. Each generator controls one X-
ray tube. Software control of X-ray settings.
Updated electronic board for the updated tubes. | No change compared to ExacTrac Dynamic 1.0 | No changes |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| ExacTrac
Console | ExacTrac Console (System start/shut down, X-ray
acquisition)
Image: ExacTrac Dynamic 1.0 K201276 Console | ExacTrac Console (System start/shut down, X-ray
acquisition)
Image: ExacTrac Dynamic 1.1 Console | No change |
| X-ray Sources | Varex G-892 Sources (Housing: Varex B-130) | Varex G-892 Sources (Housing: Varex B-130) | No change |
| Flat Panel
Detector
including
Power Supply | Flat Panel Detector
Varex PaxScan 3030DX | no change compared to predicate | No change |
5
6
7
| Features | ExacTrac Dynamic 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| 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 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| Wall mounted
Touch Screen
Monitor | Image: ExacTrac Dynamic 1.0 K201276 | Image: ExacTrac Dynamic 1.1 | 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 |
| Features | ExacTrac Dynamic 1.0 K201276 (Primary
Predicate) | ExacTrac Dynamic 1.1 (Subject Device) | Comments |
| In Floor | The In-Floor is used to install on Varian and
Elekta LINAC's | Update of In- Floor Covers including a yellow light
and updated design. | Update of design, including
added light. No functional
change |
| Patient
Feedback
System | Not included | 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 the live respiratory status and
the DIBH Gating Window. The System is only for
supporting the patients, a treatment without is also
possible. | New part introduced due to the
addition of DBIH feature. |
| 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 |
8
9
10
4. Performance Data
The following tests were conducted:
- . Compatibility Tests:
- Cybersecurity Tests: ●
- o ETD Pen Test
- o Vulnerability Test
- . Accuracy Test: The test objective is to verify that accuracy specifications for positioning and monitoring of ExacTrac Dynamic are not affected by the selected workflow, treatment parameters and different phantom positions. Also, within this test plan the correct display of deviation indicators and X-ray/DRR overlays as well as the correct transfer and adjustment of shifts and rotations to the patient support system.
- . Biological Evaluation: It examines the materials used in the device, considers the application of biological and chemical tests, and the history of safety and efficacy of the device materials in humans.
- . Usability Evaluation
- Routine Software verification to confirm that the specifications met the requirements
Clinical Validation
For the new feature, a clinical evaluation was performed which was based on literature review, performance evaluation on phantoms and a clinical investigation for DIBH.
Overview of the Pre-market, single-center Clinical Investigation:
Since the functionality to generate a respiratory signal is new to the Subject Device, a clinical investigation was performed to evaluate the surface camera system-based components of the ETD DIBH module.
Study Objectives:
-
- ETD can assist a human eligible for DIBH (Paul Keall, 2006) to reproduce a defined state of deep inspiration breath-hold (DIBH) within +/- 3 mm.
-
- Regarding the pre-positioning within the DIBH workflow based on ETD's 3D' surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.
Study population: 13 female subjects.
The first study population (patient population), consisted of subjects who are women who were diagnosed with breast cancer that is indicated for a treatment with radiation therapy with the DIBH technique and who are currently, or who have currently been treated with this technique.
The second study population (volunteer population) consisted of subjects who are healthy women who resembled patients that are typically diagnosed with breast cancer as far as possible, concerning their physiognomy and age, and who can perform sufficiently deep and long DIBHs.
All acceptance criteria for the successful completion of the study were passed. No adverse events or adverse device deficiencies were observed.
11
5. Conclusion
Based on the clinical and non-clinical testing conducted for the Subject Device as listed above and based on the Substantial Equivalence discussion, the Subject Device was demonstrated to be as safe and effective as the predicate device.