(169 days)
Not Found
No
The summary describes standard medical image processing and analysis tools, including image registration, contouring, and dose calculation. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is a software package for display, evaluation, and digital processing of medical image data and treatment plans, and it explicitly states, "VERIQA must not be used for treatment planning." It supports analysis and quality assurance, not direct therapeutic intervention.
No
The device is described as a software package for display, evaluation, and digital processing of medical image data sets and treatment plans, and specifically states it "must not be used for treatment planning." It supports evaluation and data management, and aids in tasks like localization and definition of structures, but does not provide a medical diagnosis itself.
Yes
The device description explicitly states "Software for viewing and analyzing of DICOM and DICOM RT data..." and the intended use describes it as a "software package". There is no mention of accompanying hardware components that are part of the device itself. The performance studies focus on software verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- VERIQA's Intended Use: The intended use of VERIQA is focused on the display, evaluation, and processing of medical image data sets and treatment plans in radiation oncology. It works with imaging modalities like CT, MR, and PET.
- Lack of Biological Sample Analysis: There is no mention of VERIQA analyzing biological samples from a patient. Its function is centered around the manipulation and analysis of medical images and related data.
Therefore, VERIQA falls under the category of medical imaging software or radiation therapy planning/evaluation software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
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 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
2
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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3
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-Werkstaetter
Dr. Pychlau GmbH |
|----------------------|-----------------------------------------------------------------------|
| Company Address: | Loerracher Strasse 7
79115 Freiburg
Germany |
| 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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Image /page/4/Picture/1 description: The image shows the logo for PTW. The logo consists of the letters "P", "T", and "W" in a bold, sans-serif font. A red triangle is positioned above the "T", pointing downwards. The letters are black, and the background is white.
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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Image /page/5/Picture/1 description: The image shows the text "510(k) premarket notification". The text is in bold font. The text is centered in the image.
Image /page/5/Picture/2 description: The image shows the letters PTW in a stylized font. The letters are black, and there is a red triangle pointing downwards above the letter T. The background is white.
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 dose | |||
| calculation based on | |||
| DICOM data from | |||
| TPS | Yes | ||
| for conventional Elekta and | |||
| Varian linacs. | Yes | ||
| for conventional Elekta and | |||
| Varian linacs and Accuray | |||
| Tomotherapy. | No | ||
| Monte Carlo based | |||
| dose calculation | Yes | ||
| for conventional Elekta and | |||
| Varian linacs. | Yes | ||
| for Accuray Tomotherapy. | No | ||
| Visualization of CT, | |||
| dose and structures | Yes | ||
| visualization in RT viewer: | |||
| VERIQA RT View | Yes | ||
| Visualization in web-based | |||
| slice viewer. | Yes | ||
| Support of CT, MR | |||
| and PET according | |||
| DICOM 3.0 standard | Yes | ||
| VERIQA RT View | No | Yes | |
| Calculation of 3D- | |||
| gamma distribution | Yes | Yes | No |
| Visualization of 3D- | |||
| gamma distribution | Yes | ||
| visualization in RT viewer: | |||
| VERIQA RT View | Yes | ||
| Visualization in web-based | |||
| slice viewer. | No | ||
| Calculation of dose- | |||
| volume-histograms | Yes | Yes | No |
| Visualization of dose- | |||
| volume-histogram | Yes | Yes | No |
| Image registration | Yes | ||
| VERIQA RT Evaluate | No | Yes | |
| Fusion display | Yes | ||
| VERIQA RT View | No | Yes |
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510(k) premarket notification
Image /page/6/Picture/2 description: The image shows a logo with the letters PTW in a stylized font. A red triangle is positioned above the letter T. The letters are black against a white background.
| Manufacturer | PTW Freiburg | Sun Nuclear | MIRADA MEDICAL |
|---|---|---|---|
| Product name | VERIQA | SunCHECK | MIRADA RTx |
| Localization and | |||
| definition of structures | Yes, | ||
| VERIQA RT Evaluate | No | Yes | |
| Creation, transfer and | |||
| modification of | |||
| contours | Yes, | ||
| VERIQA RT Evaluate | No | Yes | |
| Automated | |||
| processing of | |||
| secondary checks | Yes | Yes | No |
| Template based | |||
| evaluation | Yes | Yes | No |
| Automatic notification | Yes, Email notification | Yes, Email notification and via | |
| notification center (software | |||
| internal) | No | ||
| Alert system | Yes, | ||
| Colour coded (red: failed, | |||
| orange: warning, green: | |||
| passed) | Yes | ||
| Colour coded (red: failed, | |||
| green: passed) | No | ||
| Digital evaluation | |||
| approval and reject | Yes | Yes | No |
| Generation of PDF | |||
| Report | Yes | Yes | No |
| Visualization of | |||
| DICOM RT Plans | Yes, visualization in RT viewer: | ||
| VERIQA RT View | Yes, Visualization in web-based | ||
| slice viewer. | Yes | ||
| Modular software | |||
| platform | 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.