(46 days)
No
The summary describes image processing, registration, and tracking techniques, but does not mention AI, ML, or related terms like neural networks or deep learning. The performance studies focus on traditional software and hardware testing methods, not AI/ML model evaluation metrics.
No
Explanation: The device is a patient positioning and monitoring system that works in conjunction with a radiation therapy linear accelerator. Its function is to localize and correct patient position to ensure accurate delivery of radiation, rather than directly providing therapy itself.
No
ExacTrac Vero is a patient positioning and monitoring system used for aligning and tracking patient position during radiation therapy treatments. While it uses imaging for localization and correction, its primary function is to facilitate the delivery of therapy, not to provide a medical diagnosis of a disease or condition.
No
The device description explicitly mentions "optical tracking of infrared reflective markers" and "infrared tracking of external surrogate markers," which are hardware components. It also describes "Stress tests of material to verify that it does not break," indicating physical components are part of the system.
Based on the provided text, ExacTrac Vero is not an In Vitro Diagnostic (IVD) device.
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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ExacTrac Vero's Function: ExacTrac Vero is a patient positioning and monitoring system used in conjunction with a linear accelerator for radiation therapy. Its primary function is to localize and correct the patient's position before and during treatment using imaging modalities like X-ray, Cone Beam CT, and infrared tracking. It does not analyze specimens from the human body.
- Intended Use: The intended use clearly states its purpose is for patient positioning and monitoring during radiation therapy, not for diagnostic testing of biological samples.
- Device Description: The device description focuses on its role in image-guided radiation therapy, including patient positioning, monitoring, and aligning the treatment beam with the target. There is no mention of analyzing biological specimens.
Therefore, ExacTrac Vero falls under the category of a medical device used for treatment delivery and patient management during radiation therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.
ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.
ExacTrac Vero uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.
Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
Product codes
IYE
Device Description
ExacTrac Vero is a patient positioning and monitoring system for the MHI-TM2000 Linear Accelerator System by Mitsubishi Heavy Industries Ltd. providing the following main features:
- Patient positioning based on comparison between X-ray images and . CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data and CT data provided by a treatment planning system.
- Optionally providing position data for the pan/tilt motion of the MHI-. TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data is based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.
- Monitoring of the patient position during treatment. .
The following main functionalities were already available for the predicate device ExacTrac 3td Party (K072046) and have been found to be substantially equivalent:
- Patient positioning based on comparison between X-ray images, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- Both modalities can be based on anatomical landmarks or implanted . markers.
- . Monitoring of the patient position during treatment.
The new functionality for treatment of moving targets was found to be substantially equivalent with the predicate device Synchrony® Respiratory Tracking System (K120233) by Accuray Inc.
This new feature provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data are based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.
Changes to Predicate Device ExacTrac 3"d Party (K072046):
ExacTrac Vero introduces a new functionality that provides in combination with the MHI-TM2000 linear accelerator the option of aligning the treatment beam with moving targets. This new function provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with the breathing induced movement of the target.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Cone Beam CT
Anatomical Site
Not Found
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)
Nonclinical Tests:
- Software memory leakage tests using special libraries or tools.
- Software stress tests with e.g. random input, low memory conditions, network failure, low, high, positive/negative values, etc.
- Stepping through the code using the debugger focusing on the data flow.
- Check every compiler warning and remove the cause for the warning (although some warnings still remain due to old code basis).
- Code reviews.
- Use of a dynamic analysis tool.
- Usability tests, prototyping and tests in simulated environment.
- Worst case analysis of an assembly to verify that components are designed properly and not subject to overstress during handling and use.
- Drawing review.
- Stress tests of material to verify that it does not break, including safety margins i.e. 4x or 8x its weight.
- Biocompatibility tests.
- Prototyping.
- EMC testing in accredited laboratory.
- Testing in clinical similar environment for usability.
Clinical Evaluation:
- Literature review.
- Simulated treatment of anthropomorphic human-bone phantoms within a simulated clinical environment.
- Retrospective analysis of correlation between breathing and turnor motion.
- Analysis of existing x-ray image sets acquired during routine clinical use of predicate devices.
The verification and validation proves the safety and effectiveness of the system. The information provided by Brainlab in this 510(k) application was found to support a substantial equivalence decision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExacTrac 3rd Party (K072046), Synchrony® Respiratory Tracking System (K120233)
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
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR EXACTRAC VERO
.
| Manufacturer: | Brainlab AG
Kapellenstrasse 12
85622 Feldkirchen
Germany |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 8/9/2012 |
| Device: | ExacTrac Vero |
| Trade name: | ExacTrac® Vero |
| Common/Classification
Name: | Patient Positioning System, Radiation Therapy, Charged-Particle, Medical |
| Predicate Device: | ExacTrac 3rd Party (K072046)
Synchrony® Respiratory Tracking System (K120233) by Accuray Inc. |
| Device classification
name: | System, Radiation Therapy, Charged-Particle, Medical |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.5050 |
| Product Code: | IYE |
| Indication for use | ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000
radiation therapy linear accelerator system manufactured by Mitsubishi Heavy
Industries, Ltd. |
| | ExacTrac Vero uses the images received from the MHI-TM2000 linear
accelerator for analyzing the current patient position and calculating - when
applicable - a necessary correction shift. The correction shift is then exported
to the MHI-TM2000 linear accelerator. |
| | ExacTrac Vero uses stereoscopic x-ray or cone beam CT registration and
optical tracking of infrared reflective markers in order to localize and correct
the patient position before and during treatment. |
| | Optionally ExacTrac Vero provides position data for the pan/tilt motion of the
TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of
the beam orientation with a moving target. The position data is based on target
detection via X-ray imaging and IR tracking of external surrogate markers. |
FORM 04-195
REVISION 1
1
Device description:
ExacTrac Vero is a patient positioning and monitoring system for the MHI-TM2000 Linear Accelerator System by Mitsubishi Heavy Industries Ltd. providing the following main features:
- Patient positioning based on comparison between X-ray images and . CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data and CT data provided by a treatment planning system.
- Optionally providing position data for the pan/tilt motion of the MHI-. TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data is based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.
- Monitoring of the patient position during treatment. .
The following main functionalities were already available for the predicate device ExacTrac 3td Party (K072046) and have been found to be substantially equivalent:
- Patient positioning based on comparison between X-ray images, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- . Patient positioning based on comparison between Cone Beam CT data, provided by an Imaging Device of the MHI-TM2000 Linear Accelerator System, and CT data provided by a treatment planning system.
- Both modalities can be based on anatomical landmarks or implanted . markers.
- . Monitoring of the patient position during treatment.
The new functionality for treatment of moving targets was found to be substantially equivalent with the predicate device Synchrony® Respiratory Tracking System (K120233) by Accuray Inc.
This new feature provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with a moving target. The position data are based on infrared tracking of external surrogate markers and the calculated correlation between those external markers and implanted marker positions as detected in X-ray images.
Changes to Predicate Device ExacTrac 3"d Party (K072046):
ExacTrac Vero introduces a new functionality that provides in combination with the MHI-TM2000 linear accelerator the option of aligning the treatment beam with moving targets. This new function provides position data for the pan/tilt motion of the MHI-TM2000 gantry head controller for continuous alignment of the beam orientation with the breathing induced movement of the target.
FORM 04-195
Technological characteristics and substantial equivalence:
2
Statement regarding nonclinical tests:
When verifying the design the following methods were used:
- Software memory leakage tests using special libraries or tools. .
- . Software stress tests with e.g. random input, low memory conditions, network failure, low, high, positive/negative values, etc.
- Stepping through the code using the debugger focusing on the data flow. .
- Check every compiler warning and remove the cause for the warning . (although some warnings still remain due to old code basis).
- . Code reviews.
- Use of a dynamic analysis tool. .
- . Usability tests, prototyping and tests in simulated environment.
- . Worst case analysis of an assembly to verify that components are designed properly and not subject to overstress during handling and use.
- . Drawing review.
- Stress tests of material to verify that it does not break, including safety . margins i.e. 4x or 8x its weight.
- Biocompatibility tests. .
- Prototyping. .
- EMC testing in accredited laboratory. .
- � Testing in clinical similar environment for usability.
For the clinical evaluation the following validation methods and data sources have been used:
- Literature review. .
- Simulated treatment of anthropomorphic human-bone phantoms within a . simulated clinical environment.
- Retrospective analysis of correlation between breathing and turnor motion. .
- . Analysis of existing x-ray image sets acquired during routine clinical use of predicate devices.
Conclusions
Statement regarding
clinical performance
data
ExacTrac Vero has been verified and validated according to Brainlab procedures for design and development. The verification and validation proves the safety and effectiveness of the system. The information provided by Brainlab in this 510 (k) application was found to support a substantial equivalence decision.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - W066-G609 Silver Spring, MD 20993-0002
Mr. Alexander Schwiersch Regulatory Affairs Manager Brainlab AG-R&D RT Kapellenstraße 12 Feldkirchen, Bavaria 85622 GERMANY
Re: K122451
Trade/Device Name: Exactrac Vero Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 9, 2012 Received: August 13, 2012
Dear Mr. Schwiersch:
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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely Yours,
Janine M. Morris
Director Bivision of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE
510(k) Number (if known): K122451
Device name: ExacTrac Vero
Indication for use:
ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd.
ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator.
ExacTrac Vero uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.
Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Munkel D. O'Dell
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Sa
510(k) K122451
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