(111 days)
FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. FlexView Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements.
Not intended for primary diagnosis of mammographic images.
Not intended for diagnostic use on mobile devices.
FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that may integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software.
The FlexView Diagnostic application has the following primary features and functions:
- Zero-footprint Web browser based
- Medical image upload, transfer and display of medical images between facilities
- Allows access to images for all participants in the healthcare process, including radiologists, technologists, physicians, nurses and other patient care practitioners
- Serves as an information and data management system for DICOM and non-DICOM medical images
- Contains functionality to view, annotate and measure images
- Contains industry-standard tools for image manipulation, annotation and measurements
- Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR
- Encrypted transmission of medical images through secured networks
- HIPAA-compliant data management, including centralized storage of user activities via audit trails
FlexView Diagnostic consists of configurable software-only modules that display and process digital medical images, and associated medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. The web browser based medical image viewer serves as the frontend module with which users interact when viewing the imaging data and other data.
The backend module handles the connection and processing of data from a variety of sources within the health system, in view of preparing visualizations to be rendered by the viewer.
FlexView Diagnostic can connect and access the medical images across different sources in a health system: such as an existing PACS, cloud storage or local server-based storage. The data connection and imaging data processing is handled by the FlexView backend module which supports the standardized transmission protocol as defined in the DICOM standard.
Users interact with FlexView Diagnostic through a standard web browser, thus providing access to full quality images from anywhere with an Internet access. Flex View Diagnostic utilizes authorization and authentication mechanisms to ensure that only authorized users can access the imaging data. The system extends beyond the hospital and its internal network. With proper authorization, FlexView Diagnostic can be accessed by clinical users outside of the hospital network. This way referring physicians can easily call up the imaging data of their patients or external expert accessing the imaging data for additional opinions.
After carefully reviewing the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the specified details. The document provides a 510(k) summary for the "FlexView Diagnostic" device, which focuses on demonstrating substantial equivalence to a predicate device ("ZeeroMED View").
While it mentions "Acceptance criteria for this test included statistical analyses such as mean, standard deviation, standard error and a one tailed t-test," it does not provide the actual numerical acceptance criteria (e.g., "mean delta must be less than X units").
Here's a breakdown of why I cannot complete your request with the desired information:
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Table of Acceptance Criteria and Reported Device Performance:
- The document states, "Acceptance criteria for this test included statistical analyses such as mean, standard deviation, standard error and a one tailed t-test." However, it does not specify the actual numerical acceptance criteria (e.g., the threshold for the mean delta, the p-value for the t-test, or the target standard deviation).
- Similarly, it states, "Verification testing for all measurement tools passed the predetermined acceptance criteria," but it does not report the device's actual performance metrics (e.g., the calculated mean delta for length measurements, the standard deviation observed).
- Therefore, I cannot create the table you requested with specific numerical values for acceptance criteria and reported device performance.
-
Sample size used for the test set and the data provenance:
- The document mentions "phantom (calibrated and uncalibrated) DICOM images" for measurement accuracy testing but does not specify the number of images or individual measurements included in the test set.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states, "measurement accuracy testing involved evaluating the difference (i.e., delta) between the expected length and the measurement entered by the user." This implies that a "user" performed the measurements. However, it does not specify if these "users" were experts, their number, or their qualifications. It also doesn't explicitly state who established the "expected length" (ground truth) for the phantom images.
-
Adjudication method for the test set:
- No adjudication method is described. The testing involves comparing user measurements to an "expected length," not a consensus among multiple readers.
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- No MRMC study is mentioned. The testing described is a standalone measurement accuracy test, not a comparative study of human readers with or without AI assistance.
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Standalone (algorithm only without human-in-the-loop performance) study:
- The "measurement accuracy testing" is for the device's measurement tools, which are part of the software's functionality. The description states it involved "manual testing" and "measurement entered by the user." This indicates it assesses the device's functionality with a human-in-the-loop (the user performing measurements). It is not a standalone algorithm performance test in the typical sense of an AI interpreting images on its own.
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Type of ground truth used:
- For the measurement accuracy testing, the ground truth was the "expected length" from "phantom (calibrated and uncalibrated) DICOM images." This can be considered a known, objective measurement established from the phantom characteristics.
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Sample size for the training set:
- The document does not mention a training set sample size or any details about a training set. The device, FlexView Diagnostic, is described as a "Medical Image Management And Processing System" and a "DICOM Viewer" with tools for image manipulation and measurement. It doesn't appear to be an AI/ML device that requires a training set in the typical sense for learning predictive models.
-
How the ground truth for the training set was established:
- Since no training set is mentioned, this information is not available.
In summary, the provided document focuses on general software verification and validation, and specific measurement accuracy testing of the device's tools. It demonstrates that the device performs equivalently to a predicate device based on these non-clinical tests, but it does not delve into the detailed quantitative performance metrics or study designs typically found for AI/ML diagnostic algorithms.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Radical Imaging, LLC % Meritxell Martinez Regulatory Consultant Innolitics, LLC 1101 West 34th St #550 Austin, TX 78705
Re: K233226
January 17, 2024
Trade/Device Name: FlexView Diagnostic (v1.1.20) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 28, 2023 Received: December 22, 2023
Dear Meritxell Martinez:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
FlexView Diagnostic (v1.2.7)
Indications for Use (Describe)
FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. FlexView Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements.
Not intended for primary diagnosis of mammographic images.
Not intended for diagnostic use on mobile devices.
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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1. CONTACT INFORMATION
| Company Name | Radical Imaging LLC |
|---|---|
| Address | 179 Great Road #233, Stow, MA 01775 |
| Phone Number | 978-853-9281 |
| Fax Number | N/A |
| Company Contact | Rob Lewis, CEO and Founder |
| rob.lewis@radicalimaging.com | |
| Primary Correspondent | Meritxell Martinez, Innolitics |
| mmartinez@innolitics.com | |
| Date Prepared | January 12th, 2024 |
2. DEVICE INFORMATION
| Trade Name | FlexView Diagnostic |
|---|---|
| Common Name | DICOM Viewer |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Class | Class II |
| Panel | Radiology |
3. PREDICATE DEVICE INFORMATION
| Predicate Device Name | ZeeroMED View |
|---|---|
| Predicate Device 510(k) Number | K200546 |
| Product Code | LLZ |
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| Regulation Number | 892.2050 |
|---|---|
| Class | Class II |
| Panel | Radiology |
4. DEVICE DESCRIPTION
FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that mav integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software.
The FlexView Diagnostic application has the following primary features and functions:
- . Zero-footprint Web browser based
- Medical image upload, transfer and display of medical images between facilities •
- Allows access to images for all participants in the healthcare process, including radiologists, technologists, physicians, nurses and other patient care practitioners
- Serves as an information and data management system for DICOM and non-DICOM • medical images
- Contains functionality to view, annotate and measure images .
- Contains industry-standard tools for image manipulation, annotation and measurements .
- Advanced image manipulation functions like view synchronization across series, 3D . visualization like MIP and MPR
- Encrypted transmission of medical images through secured networks ●
- HIPAA-compliant data management, including centralized storage of user activities via . audit trails
FlexView Diagnostic consists of configurable software-only modules that display and process digital medical images, and associated medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. The web browser based medical image viewer serves as the frontend module with which users interact when viewing the imaging data and other data.
The backend module handles the connection and processing of data from a variety of sources within the health system, in view of preparing visualizations to be rendered by the viewer.
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Image /page/5/Picture/0 description: The image is a square logo with a dark blue background. In the center of the logo is a small white square. Surrounding the white square are four light blue L-shaped figures, one in each corner of the logo. The L-shaped figures are oriented so that they appear to be pointing towards the center of the logo.
FlexView Diagnostic can connect and access the medical images across different sources in a health system: such as an existing PACS, cloud storage or local server-based storage. The data connection and imaging data processing is handled by the FlexView backend module which supports the standardized transmission protocol as defined in the DICOM standard.
Users interact with FlexView Diagnostic through a standard web browser, thus providing access to full quality images from anywhere with an Internet access. Flex View Diagnostic utilizes authorization and authentication mechanisms to ensure that only authorized users can access the imaging data. The system extends beyond the hospital and its internal network. With proper authorization, FlexView Diagnostic can be accessed by clinical users outside of the hospital network. This way referring physicians can easily call up the imaging data of their patients or external expert accessing the imaging data for additional opinions.
4.1. Key Marketing Claims
FlexView Diagnostic is a zero-footprint web viewer platform for medical images. FlexView Diagnostic allows easy access to cloud-stored image files. FlexView Diagnostic supports images that are compliant with the DICOMweb standard.
5. INDICATIONS FOR USE
FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. Flex View Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements.
Not intended for primary diagnosis of mammographic images.
Not intended for diagnostic use on mobile devices.
6. PREDICATE DEVICE COMPARISON
| Feature | FlexView Diagnostic | ZeeroMED View(K200546) | Comments |
|---|---|---|---|
| Intended Use | FlexView Diagnostic is a softwareapplication used for reference anddiagnostic viewing and analysis ofmulti-modality medical imaging andnon-imaging data (e.g., video | ZeeroMED View softwareisintended for use as adiagnostic and analysis toolfor diagnostic images for | FlexView and the predicatedevice (ZeeroMED View)have similar indications foruse, as they are both indicatedto view, display and manage |
| Feature | FlexView Diagnostic | ZeeroMED View(K200546) | Comments |
| information) with associated reportsand information. FlexView enablesqualified healthcare professionals,including (but not limited to)physicians, surgeons, nurses, andadministrators to receive and viewpatient images, documents and data.FlexView allows qualified users toperform simple and complex imagemanipulations (includingwindow/level, markups, 3Dvisualization) and measurements.Not intended for primary diagnosis ofmammographic images.Not intended for diagnostic use onmobile devices. | hospitals, imaging centers,radiologists, readingpractices and any user whorequires and is grantedaccess to patient image,demographic and reportinformation. ZeeroMEDView displays and managesdiagnostic quality DICOMimages. ZeeroMED View isnotintended for diagnostic usewith mammographyimages. Usage formammography is forreference and referral only.ZeeroMED View is notintended for diagnostic useon mobile devices. | patient images. Both devicesare indicated for prescription-use in patients who've hadnon-mammographic medicalimages taken.FlexView and ZeeroMEDView share the same intendeduse to be used as diagnosticand analysis tools for viewingand manipulating medicalimages. Both devices are alsointended for use in hospitals,imaging centers, radiologypractices, and readingpractices.Neither FlexView norZeeroMED View is intendedfor primary diagnosis ofmammographic images, norfor diagnostic use on mobiledevices. | |
| MammographicUse | No | No | Same |
| DICOM ImageLoading andVisualization | Yes | Yes | Same |
| Can Search PatientStudy Data | Yes | Yes | Same |
| UserAuthentication | Yes | Yes | Same |
| Window/ LevelAdjustments | Yes | Yes | Same |
| Control the ImageView: Rotate, Pan,and Zoom | Yes | Yes | Same |
| Image DisplayOperations | Flip horizontal, verticalRotate left, rightResetMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top | Flip horizontal, verticalRotate left, rightResetMagnificationScrollLayout 1x1 -3x3Thumbnails left, right, top | PET Fusion is imaging notsupported in FlexView versionv1.2.7. However, thisdifference does not raise anyconcerns. All of FlexView'sother image display operations(i.e., those listed in table) are |
| Feature | FlexView Diagnostic | ZeeroMED View(K200546) | Comments |
| bottomVolumetric rendering | bottomPET fusionVolumetric rendering | also supported by the predicatedevice. | |
| MeasurementFunctionsIncluded | Yes | Yes | Same |
| Text Annotations | Yes | Yes | Same |
| Report Generation | Yes | Yes | Same |
| Print Reports | Same | ||
| Export | Yes | Yes | Same |
| Share Function | No | Yes | Share Function not included inFlexView version v1.2.7.However, this does not raiseany different questions onsafety of effectiveness of thedevice. |
| DICOMWindowing | Yes | Yes | Same |
| ImagingModalitiesIncluded: US, CT,MRI, X-Ray | Yes | Yes | Same |
| Communications | DICOM | DICOM | Same |
| Operating SystemsSupported | Mac, Windows | Mac, Windows, Linux | The subject device supportsthe same operating systems asthe predicate device (Mac andWindows), with the exceptionof Linux. However, this doesnot raise any differentquestions on safety ofeffectiveness of the device. |
| Web BrowsersSupported | Chrome, Edge, Safari | Chrome, Edge, Firefox | The subject device supportsthe same web browsers as thepredicate device, except forFirefox. In addition, thesubject device also supportsSafari. This difference insupported web browsers does |
| Feature | FlexView Diagnostic | ZeeroMED View (K200546) | Comments |
| not raise any new questions ofsafety and effectiveness, andhas been verified throughtesting. | |||
| Mobile Device Support | No | No | Same |
| Store, Display, and TransferMedical Images | Yes | Yes | Same |
| Connects toExisting PACS | Yes | Yes | Same |
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Radical Imaging 510(k) Summary
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Radical Imaging 510(k) Summary
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Radical Imaging 510(k) Summary
6.1. Summary of Technological Characteristics Comparison
FlexView Diagnostic and ZeeroMED View share equivalent intended use and functionality, as well as similar web technologies. Both systems allow access, upload, and display of DICOM images and metadata, and provide tools and resources for physicians to review studies. Additionally, both systems are hosted on web servers and are equipped with security features and user authentication.
Both devices offer similar features such as window/level adjustments, image view controls (rotate, pan, and zoom), measurement functions, text annotations, report generation and DICOM windowing.
Additionally, both devices can connect to existing PACS systems and store, display, and transfer medical images. Both devices also support the same imaging modalities, including US, CT, MRI, and X-Ray.
There are several minor differences in technological characteristics between the two devices:
- The predicate device has a "Share Function," which enables remote, real-time . collaboration among multiple users. This feature is not currently supported by the subject device.
- The predicate device supports Mac, Windows, and Linux operating systems, while the ● subject device only supports Mac and Windows.
- The predicate device supports Chrome, Edge, and Firefox browsers, while the subject . device supports Chrome, Edge, and Safari.
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The lack of features (e.g., share function, Linux OS compatibility, and Firefox compatibility) in the subject device that are found in the predicate device is not a concern relating to safety or effectiveness, as these are not required to meet the device's intended use. Similarly, the presence of additional features (e.g., compatibility with additional internet browsers) in the subject device that are not found in the predicate device does not raise any new questions of safety and effectiveness and have been properly verified through testing.
7. DISCUSSION OF NON-CLINICAL TESTING
FlexView Diagnostic was subjected to the following non-clinical testing.
7.1. Software Verification and Validation
Software verification and validation testing were conducted on the Flex View Diagnostic system and documentation was provided as recommended by FDA's 2023 Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."
The software verification and validation testing verified that the design requirements were successfully met. The intended use and user needs were successfully validated.
As the intended use, indications, functionality and performance of Flex View Diagnostic and the ZeeroMED View are equivalent, the result of the non-clinical performance testing is evidence that the subject device performs in an equivalent manner to the predicate device.
7.2. Measurement Accuracy
Verification of Flex View Diagnostic included manual testing of the measurement tools (length, bidirectional and angle measurements) using phantom (calibrated and uncalibrated) DICOM images.
Measurement accuracy testing involved evaluating the difference (i.e., delta) between the expected length and the measurement entered by the user. Delta results were calibrated to +/- 1 units, which is equivalent to +/- 1 units relative to the acquisition size and display resolution. This calibration ensured consistent accuracy across different zoom levels.
Acceptance criteria for this test included statistical analyses such as mean, standard deviation, standard error and a one tailed t-test. Verification testing for all measurement tools passed the predetermined acceptance criteria.
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7.3. Conclusion
The subject device shares similar technological characteristics, intended use, and functionality with the predicate device. There are no differences between the devices that raise new questions of safety and effectiveness.
Furthermore, non-clinical performance test data and software verification and validation demonstrate that FlexView Diagnostic performs comparably to the predicate device in terms of safety and effectiveness.
Based on the device comparisons and the acceptable testing results, it is determined that FlexView Diagnostic is substantially equivalent to the predicate device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).