(61 days)
ExacTrac K120789
Not Found
No
The summary describes a system that uses image comparison and calculation of shifts based on predefined criteria and accuracy requirements. There is no mention of AI, ML, or related concepts like training/test sets, which are typically associated with AI/ML development and validation in medical devices. The functionality described appears to be based on deterministic algorithms for image registration and deviation detection.
No.
The device is intended to position and monitor patients accurately for radiation treatment, not to deliver or directly cause a therapeutic effect itself.
No
Explanation: The device is described as a patient positioning and monitoring system for radiotherapy. Its primary function is to align patients for treatment and monitor their position during treatment. While it compares actual patient position to planned position and calculates deviations, this is for treatment delivery and patient safety, not for diagnosing a medical condition or disease.
No
The device description explicitly states that ExacTrac as a medical device consists of both Hardware and Software.
Based on the provided information, the ExacTrac Dynamic device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ExacTrac Dynamic's Function: The description clearly states that ExacTrac Dynamic is a patient positioning and monitoring device used in radiotherapy. It uses imaging modalities (X-ray, CT) to determine and track the patient's position relative to a treatment beam. It does not analyze biological specimens.
The device's purpose is to ensure accurate delivery of radiation therapy to a target within the patient's body, which is a therapeutic procedure, not an in vitro diagnostic test.
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 deviations 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 add-on 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 the patient is monitored with a surface camera and Xray to ensure no misalignment due to patient movement.
ExacTrac as a medical device consists of Hardware and Software. Together they are ExacTrac Dynamic.
ExacTrac Dynamic shall be installed in a treatment room within a hospital radiation therapy department.
Environmental conditions are as follows: Humidity range: 30% - 70% Ambient temperature: 16°C - 35°C Atmospheric pressure: 800hPa - 1060hPa
ExacTrac uses X-ray images acquired with two X-ray tubes and two amorphous silicon detectors to compare the current patient position with the previously planned patient position, based on CT volumetric scans.
The current patient position is monitored using a surface monitoring system.
If necessary, the patient position is corrected using 3rd patient treatment tables with or without pitch and roll correction possibilities.
Stereotactic radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are a highly accurate form of the radiation therapy initially developed to treat small (benign or malignant) tumors and functional abnormalities of the brain.
During treatment a high dose of radiation is delivered within millimeter accuracy to the planned target volume (PTV) while minimizing the dose to the surrounding healthy tissue and organs at risk (OARs). For an accurate dose delivery a precise patient positioning is necessary and an eventual re-positioning of the patient in case of a patient movement during the treatment. The patient positioning system is based on two non-coplanar x-ray 2D image acquisition, that is accurately aligned to the volumetric planning CT (from the plan), the transformation matrix (of the 2D or 3D alignment) is sent to the treatment couch moving the patient to the planned iso-center of the treatment delivery system (Linac). During the treatment delivery the patient movement is monitored via a (3D) surface and a thermal information.
Additionally, an x-ray based position may be acquired and compared with the planned patient position. Quality assurance procedure are included to ensure a calibration of ExacTrac to itself and to the LINAC
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, CT
Anatomical Site
Anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiotherapy environment, hospital radiation therapy department
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)
Various verification and validation tests were carried out on the System, Hardware and Software as applicable.
Essential Performance characteristics include:
- Providing a patient position for accurate targeting
- Monitoring the patient position
- Holding the treatment beam in case of deviations during treatment monitoring (optional)
In detail:
- Positioning: Providing a shift for the patient support system compensating the deviation between patient and planned position, where the shift is calculated with an accuracy of 1mm based on stereo x-ray images.
- Positioning and Monitoring: Display of an X-ray / DRR overlay and indicating a corresponding deviation between patient position and planned position, where the deviation is calculated with an accuracy of 1mm based on stereo x-ray images.
- Monitoring: Indicating a deviation exceeding a predefined tolerance between patient position and a reference position based on surface tracking with an accuracy of 1mm (during irradiation).
- Monitoring: Indicating a deviation exceeding a predefined tolerance between patient position and planned position based on stereo X-rays with an accuracy of 1mm (during irradiation).
- Providing a "Beam hold" signal to the LINAC within 3 sec, if there is a deviation between patient position and reference position exceeding tolerance limits as adjusted by the user.
Software verification and validation testing were conducted. The software was considered a "moderate" level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of 1mm for calculated shifts and deviations.
Beam hold signal within 3 seconds.
Predicate Device(s)
ExacTrac K120789
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.
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July 13, 2020
Image /page/0/Picture/1 description: The image shows 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 GERMANY
Re: K201276
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: May 6, 2020 Received: May 13, 2020
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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201276
Device Name ExacTrac Dynamic
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 deviations 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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Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in bold, sans-serif font on the right. The symbol appears to be a stylized representation of the human brain.
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Image /page/3/Picture/2 description: The image shows the word "BRAINLAB" in bold, black letters. To the left of the word is a stylized logo that appears to be three curved lines stacked on top of each other. The logo is also in black and is smaller than the word "BRAINLAB". The overall impression is of a clean and modern logo for a company or organization.
510(k) Summary
May 6, 2020
| General Information | |
|---|---|
| Manufacturer | Brainlab AG |
| Establishment Registration | 8043933 |
| Device Name | Accelerator, Linear, Medical |
| Trade Name | ExacTrac Dynamic |
| Classification Name | Medical charged-particle radiation therapy system |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device(s) | ExacTrac K120789 |
| Contact Information | |
|---|---|
| Primary Contact | Alternate Contact |
| Chiara Cunico | |
| Manager RA | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com | Regulatory Affairs Brainlab |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 5033 | |
| Email: regulatory.affairs@brainlab.com |
1. Intended Use
ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviations 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 add-on 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
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized image of three interconnected brain-like shapes stacked vertically on the left. To the right of the image is the word "BRAINLAB" in a bold, sans-serif font. The logo is black and white.
machine's treatment position. During treatment the patient is monitored with a surface camera and Xray to ensure no misalignment due to patient movement.
ExacTrac as a medical device consists of Hardware and Software. Together they are ExacTrac Dynamic.
ExacTrac Dynamic 1.0 UDI DI: 04056481142506 ExacTrac Dynamic has no variants.
ExacTrac Dynamic shall be installed in a treatment room within a hospital radiation therapy department.
Environmental conditions are as follows: Humidity range: 30% - 70% Ambient temperature: 16°C - 35°C Atmospheric pressure: 800hPa - 1060hPa
ExacTrac uses X-ray images acquired with two X-ray tubes and two amorphous silicon detectors to compare the current patient position with the previously planned patient position, based on CT volumetric scans.
The current patient position is monitored using a surface monitoring system.
If necessary, the patient position is corrected using 3rd patient treatment tables with or without pitch and roll correction possibilities.
Stereotactic radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are a highly accurate form of the radiation therapy initially developed to treat small (benign or malignant) tumors and functional abnormalities of the brain.
During treatment a high dose of radiation is delivered within millimeter accuracy to the planned target volume (PTV) while minimizing the dose to the surrounding healthy tissue and organs at risk (OARs). For an accurate dose delivery a precise patient positioning is necessary and an eventual re-positioning of the patient in case of a patient movement during the treatment. The patient positioning system is based on two non-coplanar x-ray 2D image acquisition, that is accurately aligned to the volumetric planning CT (from the plan), the transformation matrix (of the 2D or 3D alignment) is sent to the treatment couch moving the patient to the planned iso-center of the treatment delivery system (Linac). During the treatment delivery the patient movement is monitored via a (3D) surface and a thermal information.
Additionally, an x-ray based position may be acquired and compared with the planned patient position. Quality assurance procedure are included to ensure a calibration of ExacTrac to itself and to the LINAC
3. Substantial Equivalence
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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in all caps on the right. The symbol appears to be a representation of the brain. The text is in a bold, sans-serif font.
When compared to its predicate device, the subject device remains same in terms of indications for use, the principle technique used for detection i.e., use of X-ray imaging and comparison with CT data from planning software's.
The only change is that, instead of IR Marker the subject device utilizes surface and the thermal signature of the patient. This technique, is an improvement on the IR Markers.
Additionally. ExacTrac Dynamic has an improved beam hold for when the patient is out of position. To generalize, the entire hardware was upgraded to include updated parts and to reflect the new requirements.
4. Performance Data
Essential performance characteristics
As ExacTrac Dynamic does not provide any life-sustaining nor life-monitoring functionality and is not designed for the use in surgical or invasive procedures, a guaranteed availability (uptime) of its functionality is consequently not a safety requirement and therefore not part of the essential performance.
However, whenever these functions are available they must provide the specified performance.
The Essential Performance is summarized by
- -Providing a patient position for accurate targeting
- -Monitoring the patient position
- -Holding the treatment beam in case of deviations during treatment monitoring (optional)
The Essential Performance in detail:
Positioning
- i) Providing a shift for the patient support system compensating the deviation between patient and planned position, where the shift is calculated with an accuracy of 1mm based on stereo x-ray images.
Positioning and Monitoring
- ii) Display of an X-ray / DRR overlay and indicating a corresponding deviation between patient position and planned position, where the deviation is calculated with an accuracy of 1mm based on stereo x-ray images.
Monitoring
- iii) Indicating a deviation exceeding a predefined tolerance between patient position and a reference position based on surface tracking with an accuracy of 1mm (during irradiation).
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Image /page/6/Picture/0 description: The image shows the logo for Brainlab. The logo consists of a stylized caduceus symbol on the left, followed by the word "BRAINLAB" in bold, sans-serif font. The caduceus symbol is a medical emblem featuring a staff with two snakes coiled around it.
- iv) Indicating a deviation exceeding a predefined tolerance between patient position and planned position based on stereo X-rays with an accuracy of 1mm (during irradiation).
- v) Providing a "Beam hold" signal to the LINAC within 3 sec, if there is a deviation between patient position and reference position exceeding tolerance limits as adjusted by the user.
Not considered as Essential performance, but Basic safety to be evaluated regarding EMC testing as identified by risk management:
- i) The x-ray settings transmitted to the x-ray generator must be submitted without any error or the error must be detected by ExacTrac.
- ii) Noise on the trigger signal must not start kV image acquisition or start a fluoroscopic sequence.
Various verification and validation tests were carried out on the System, Hardware and Software as applicable.
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility testing
The subject device is not patient contacting. However, some components such as Verification and Calibration phantoms, ETD consoles and other parts of the device comes in contact with the user. Based on the present biological toxicological evaluation of existing data, the device is considered to meet the requirements of ISO 10993-1 and ISO 14971 for a device with limited contact duration (≤ 24 hours). As there is no patient contact for the device, it can be considered safe and suitable for its intended use.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Subject Device, as applicable. The device is in compliance with the below listed standards for safety and EMC.
IEC 60601-1:2012
IEC 60601-1-2:2014
IEC 60601-1-3:2013
IEC 60601-1-6:2014 / 62366 2015
IEC 60601-2-68:2014
CB 60601-1 (chapter 14) and CB 62304 - 104110180MIN-004
The Aim Standard 7351731 is not considered for ExacTrac Dynamic, as ExacTrac is installed in a Bunker which is radiation protected. Also, the natural skin barrier is intact during radiotherapy / Radiosurgery.
The Subject device has passed all the necessary tests and thereby is considered safe and effective for its intended use.
Confidential
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Image /page/7/Picture/0 description: The image shows the logo for Brainlab. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in bold, uppercase letters on the right. The symbol appears to be three abstract shapes stacked vertically, possibly representing a stylized brain or neural network.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator and also since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. Section 16 has the list of documentation provided for the level of concern identified.
5. Conclusion
The comparison of ExacTrac Dynamic with the predicate device as discussed in detail in Section 12 of this document, shows that the subject device has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification activities ensured that the design specifications are met and that the subject device does not introduce new issues concerning safety and effectiveness. Hence, the subject device is substantially equivalent to the predicate device.