(169 days)
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
VERIQA software is a tool for evaluation and data management of digital images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications:
- a) Receiving, transmitting, storing, display, and processing of medical images and DICOM objects.
- b) Creating, displaying and printing of reports containing medical images.
- c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning.
- d) Localization and definition of structures such as tumors and normal tissue in medical image sets.
- e) Creation, transfer, and modification of contours and dose distributions such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management.
- f) Secondary Monte Carlo dose calculation for patient specific quality assurance.
VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.
Software for viewing and analyzing of DICOM and DICOM RT data as well as for contouring of these data for radiation therapy. All the relevant data, including image data sets and treatment plans, can be imported into VERIQA. The software enables interactive viewing of these data in 2D/3D/4D and evaluation of the treatment plans with secondary Monte Carlo 3D dose calculation. The user can register images and process RT Dose, RT Plan, and RT Structure objects. Results can be saved in the DICOM RT format for use by other systems for radiation treatment planning purposes.
The provided text describes the VERIQA device, its intended use, and a comparison with predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study that specifically proves the device meets those criteria with numerical performance data. It generally states that "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods" and "It was demonstrated that VERIQA fulfils the design specification and its intended use, and that it is equivalent to the predicate devices."
Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what can be inferred or explicitly stated.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or reported device performance metrics from a formal study. The "Device Comparison Table" on pages 5-6 lists technological characteristics and functionalities, indicating whether VERIQA and its predicates possess them ("Yes" or "No"), but not quantitative performance.
| Acceptance Criteria (Inferred from device comparison table similarities) | Reported Device Performance (as presented in the document - functional rather than quantitative) |
|---|---|
| Secondary dose calculation based on DICOM data from TPS (for conventional Elekta and Varian linacs) | Achieved (Yes) |
| Monte Carlo based dose calculation (for conventional Elekta and Varian linacs) | Achieved (Yes) |
| Visualization of CT, dose and structures (in RT viewer) | Achieved (Yes) |
| Support of CT, MR and PET according DICOM 3.0 standard | Achieved (Yes) |
| Calculation of 3D-gamma distribution | Achieved (Yes) |
| Visualization of 3D-gamma distribution (in RT viewer) | Achieved (Yes) |
| Calculation of dose-volume-histograms | Achieved (Yes) |
| Visualization of dose-volume-histogram | Achieved (Yes) |
| Image registration (in VERIQA RT Evaluate) | Achieved (Yes) |
| Fusion display (in VERIQA RT View) | Achieved (Yes) |
| Localization and definition of structures (in VERIQA RT Evaluate) | Achieved (Yes) |
| Creation, transfer and modification of contours (in VERIQA RT Evaluate) | Achieved (Yes) |
| Automated processing of secondary checks | Achieved (Yes) |
| Template-based evaluation | Achieved (Yes) |
| Automatic notification (Email notification) | Achieved (Yes) |
| Alert system (Colour coded: red: failed, orange: warning, green: passed) | Achieved (Yes) |
| Digital evaluation approval and reject | Achieved (Yes) |
| Generation of PDF Report | Achieved (Yes) |
| Visualization of DICOM RT Plans (in RT viewer) | Achieved (Yes) |
| Modular software platform | Achieved (Yes) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text only vaguely states "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device description does not imply AI assistance for human readers in the context of improving their performance, but rather offers secondary calculations and visualization tools for medical physicists and other professionals.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone performance for the Monte Carlo dose calculation ("Secondary Monte Carlo dose calculation and evaluation for patient specific quality assurance") and other automated features like "Automated processing of secondary checks" and "Automatic notification". However, specific details or results of such standalone performance are not provided, beyond the functional confirmation of their presence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For radiation therapy QA software, ground truth for dose calculation is typically established against established physics models, phantom measurements, or other validated dose calculation systems. However, the specific method is not detailed here.
8. The sample size for the training set
This information is not provided in the document. The document describes VERIQA as software for display, evaluation, and digital processing, rather than a machine learning/AI model that typically undergoes explicit "training"; thus, a traditional "training set" might not be applicable in the same way.
9. How the ground truth for the training set was established
As with point 8, this information is not provided and may not be applicable in a traditional sense for this type of software.
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PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH % Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Strasse 7 Freiburg, Baden-Württemberg 79102 GERMANY
Re: K213370
Trade/Device Name: VERIQA Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 14, 2021 Received: February 28, 2022
Dear Sandor-Csaba Ats:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie M. 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
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Indications for Use
510(k) Number (if known) K213370
Device Name VERIQA (S07031)
Indications for Use (Describe)
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
VERIQA software is a tool for evaluation and data management of digital images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications:
- a) Receiving, transmitting, storing, display, and processing of medical images and DICOM objects.
- b) Creating, displaying and printing of reports containing medical images.
- c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning.
- d) Localization and definition of structures such as tumors and normal tissue in medical image sets.
- e) Creation, transfer, and modification of contours and dose distributions such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management.
- f) Secondary Monte Carlo dose calculation for patient specific quality assurance.
VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.
The software must only be used by qualified personnel, usually medical professionals including, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and medical physicists or authorized persons.
| 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) premarket notification
Image /page/3/Picture/2 description: The image shows the letters PTGW in a bold, sans-serif font. A red triangle is positioned above the T, pointing downwards. The letters are black against a white background.
510(K) Summary
Submitter's Information 1
| Company Name: | PTW-Freiburg Physikalisch-Technische-WerkstaetterDr. Pychlau GmbH |
|---|---|
| Company Address: | Loerracher Strasse 779115 FreiburgGermany |
| Proprietary Name: | VERIQA (S07031) |
| Common Name: | Secondary check QA software |
| 510(k) number: | K213370 |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Name: | Medical charged-particle radiation therapy system |
| Classification Name: | Accelerator, Linear, Medical |
| Product code: | IYE |
| Device class: | Class II |
Predicate Device Information 2
| Proprietary Name: | SUNCHECK |
|---|---|
| Common Name: | Secondary check QA software |
| 510(k) number: | K170307 |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Name: | Medical charged-particle radiation therapy system |
| Classification Name: | Accelerator, Linear, Medical |
| Product code: | IYE |
| Device class: | Class II |
| Manufacturer: | Sun Nuclear Corporation |
| Submitted: | October 25, 2017 |
| Proprietary Name: | Mirada RTx |
| Common Name/s: | RTx, RT Server, RTx Server, Workflow Box |
| 510(k) number: | K130393 |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Name: | Medical image management and processing system |
| Classification Name: | System, Image Processing, Radiological |
| Product code: | IYE |
| Device class: | Class II |
| Manufacturer: | Mirada Medical Ltd |
| Submitted: | March 20, 2013 |
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510(k) premarket notification
Device Description 3
Software for viewing and analyzing of DICOM and DICOM RT data as well as for contouring of these data for radiation therapy. All the relevant data, including image data sets and treatment plans, can be imported into VERIQA. The software enables interactive viewing of these data in 2D/3D/4D and evaluation of the treatment plans with secondary Monte Carlo 3D dose calculation. The user can register images and process RT Dose, RT Plan, and RT Structure objects. Results can be saved in the DICOM RT format for use by other systems for radiation treatment planning purposes.
Intended Use Statement 4
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
4.1 Indications
VERIQA software is a tool for evaluation and data management of digital medical images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities.
VERIQA supports the following applications:
RT View and RT Evaluate:
- a) Receiving, transmitting, storing, retrieving, display, and processing of medical images and DICOM objects.
- b) Creating, displaying and printing of reports containing medical images.
- c) Localization and definition of structures such as tumors and normal tissue in medical image sets.
- d) Image registration, fusion display, and view of medical images for treatment plan valuation.
- e) Creation, transfer, and modification of contours and dose distributions for applications such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up andmanagement.
RT MonteCarlo 3D:
- f) Secondary Monte Carlo dose calculation and evaluation for patient specific quality assurance.
4.2 Contraindications
VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.
Intended User 4.3
The software must only be used by qualified personnel, usually medical professionals including, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and medical physicists or authorized persons.
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Substantial Equivalence 5
5.1 Technological Characteristics
The primary technologic characteristic of VERIQA can be broken up into 3 modules of functionality.
- a) The usage of three-dimensional imaging information and beam intensity information in DICOM-RT format to compute a dose distribution (also in DICOM-RT format) and a comparison of this independent calculation to the TPS dose distribution.
- b) Visualization and storage of CT/MR and PET-CT images, structure sets and dose distributions in DICOM-RT format.
- c) Contouring and image registration on the base of CT/MR images.
These technological characteristics are believed to be substantially equivalent to the predicate devices as seen in the below table.
5.2 Device Comparison Table
| Manufacturer | PTW Freiburg | Sun Nuclear | MIRADA MEDICAL |
|---|---|---|---|
| Product name | VERIQA | SunCHECK | MIRADA RTx |
| 510(k) number | K213370 | K170307 | K130393 |
| Secondary dosecalculation based onDICOM data fromTPS | Yesfor conventional Elekta andVarian linacs. | Yesfor conventional Elekta andVarian linacs and AccurayTomotherapy. | No |
| Monte Carlo baseddose calculation | Yesfor conventional Elekta andVarian linacs. | Yesfor Accuray Tomotherapy. | No |
| Visualization of CT,dose and structures | Yesvisualization in RT viewer:VERIQA RT View | YesVisualization in web-basedslice viewer. | Yes |
| Support of CT, MRand PET accordingDICOM 3.0 standard | YesVERIQA RT View | No | Yes |
| Calculation of 3D-gamma distribution | Yes | Yes | No |
| Visualization of 3D-gamma distribution | Yesvisualization in RT viewer:VERIQA RT View | YesVisualization in web-basedslice viewer. | No |
| Calculation of dose-volume-histograms | Yes | Yes | No |
| Visualization of dose-volume-histogram | Yes | Yes | No |
| Image registration | YesVERIQA RT Evaluate | No | Yes |
| Fusion display | YesVERIQA RT View | No | Yes |
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510(k) premarket notification
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| Manufacturer | PTW Freiburg | Sun Nuclear | MIRADA MEDICAL |
|---|---|---|---|
| Product name | VERIQA | SunCHECK | MIRADA RTx |
| Localization anddefinition of structures | Yes,VERIQA RT Evaluate | No | Yes |
| Creation, transfer andmodification ofcontours | Yes,VERIQA RT Evaluate | No | Yes |
| Automatedprocessing ofsecondary checks | Yes | Yes | No |
| Template basedevaluation | Yes | Yes | No |
| Automatic notification | Yes, Email notification | Yes, Email notification and vianotification center (softwareinternal) | No |
| Alert system | Yes,Colour coded (red: failed,orange: warning, green:passed) | YesColour coded (red: failed,green: passed) | No |
| Digital evaluationapproval and reject | Yes | Yes | No |
| Generation of PDFReport | Yes | Yes | No |
| Visualization ofDICOM RT Plans | Yes, visualization in RT viewer:VERIQA RT View | Yes, Visualization in web-basedslice viewer. | Yes |
| Modular softwareplatform | Yes | Yes | No |
Performance Data 6
Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods.
It was demonstrated that VERIQA fulfils the design specification and its intended use, and that it is equivalent to the predicate devices.
Summary 7
The comparison of the indications for use, the technological characteristics, the performance, safety and effectiveness of the predicate devices and the subject device has shown that the VERIQA software is as safe and effective as the predicate devices and that the application is as well or better. With respect to the device, no new questions of safety and effectiveness could be determined.
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