(111 days)
Not Found
No
The document describes a standard medical image viewer with advanced manipulation and visualization features, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No.
This device is a software application intended for diagnostic viewing and analysis of medical imaging data, not for direct therapeutic intervention. Its features focus on image display, manipulation, and data management for healthcare professionals.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data." This clearly indicates its diagnostic purpose.
Yes
The device description explicitly states that FlexView Diagnostic "consists of configurable software-only modules" and is a "stand-alone Web-based DICOM medical image viewer." It also mentions that users interact with the application through a standard web browser, implying no dedicated hardware is part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of FlexView Diagnostic clearly states its purpose is for viewing and analyzing medical imaging and non-imaging data (like video), not biological samples.
- The intended use is for diagnostic viewing and analysis of medical images. This falls under the category of medical imaging software, which is distinct from IVDs.
- The device description focuses on image processing, display, and management. This aligns with the functionality of a medical image viewer and PACS-like system, not an IVD.
Therefore, FlexView Diagnostic is a medical imaging software device, not an In Vitro Diagnostic.
N/A
# Intended Use / 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. 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.
# Product codes (comma separated list FDA assigned to the subject device)
LLZ
# 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.
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.
# Mentions image processing
Yes
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
multi-modality medical imaging (US, CT, MRI, X-Ray) and non-imaging data (e.g., video information)
# Anatomical Site
Not Found
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators. Intended for use in hospitals, imaging centers, radiology practices, and reading practices.
# 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: Verified that design requirements were met and intended use and user needs validated. Conclusion: FlexView Diagnostic performs in an equivalent manner to the predicate device.
Measurement Accuracy: Manual testing of measurement tools (length, bidirectional, and angle) using phantom (calibrated and uncalibrated) DICOM images. Acceptance criteria (statistical analyses such as mean, standard deviation, standard error, and one-tailed t-test) were met.
# 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.
[K200546](https://510k.innolitics.com/search/K200546)
# 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
§ 892.2050 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).
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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).
1
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
2
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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Image /page/3/Picture/0 description: The image is a square with a dark blue background. In each corner of the square, there is a light blue L-shaped design. In the very center of the square, there is a small white square.
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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Image /page/4/Picture/0 description: The image shows a square with a dark blue background. There are four light blue L-shaped figures, one in each corner of the square. In the very center of the square is a small white square.
| 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 software
application used for reference and
diagnostic viewing and analysis of
multi-modality medical imaging and
non-imaging data (e.g., video | ZeeroMED View software
is
intended for use as a
diagnostic and analysis tool
for diagnostic images for | FlexView and the predicate
device (ZeeroMED View)
have similar indications for
use, as they are both indicated
to view, display and manage |
| Feature | FlexView Diagnostic | ZeeroMED View
(K200546) | Comments |
| | information) with associated reports
and information. FlexView enables
qualified healthcare professionals,
including (but not limited to)
physicians, surgeons, nurses, and
administrators to receive and view
patient images, documents and data.
FlexView 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. | hospitals, imaging centers,
radiologists, reading
practices and any user who
requires and is granted
access to patient image,
demographic and report
information. ZeeroMED
View displays and manages
diagnostic quality DICOM
images. ZeeroMED View is
not
intended for diagnostic use
with mammography
images. Usage for
mammography is for
reference and referral only.
ZeeroMED View is not
intended for diagnostic use
on mobile devices. | patient images. Both devices
are indicated for prescription-
use in patients who've had
non-mammographic medical
images taken.
FlexView and ZeeroMED
View share the same intended
use to be used as diagnostic
and analysis tools for viewing
and manipulating medical
images. Both devices are also
intended for use in hospitals,
imaging centers, radiology
practices, and reading
practices.
Neither FlexView nor
ZeeroMED View is intended
for primary diagnosis of
mammographic images, nor
for diagnostic use on mobile
devices. |
| Mammographic
Use | No | No | Same |
| DICOM Image
Loading and
Visualization | Yes | Yes | Same |
| Can Search Patient
Study Data | Yes | Yes | Same |
| User
Authentication | Yes | Yes | Same |
| Window/ Level
Adjustments | Yes | Yes | Same |
| Control the Image
View: Rotate, Pan,
and Zoom | Yes | Yes | Same |
| Image Display
Operations | Flip horizontal, vertical
Rotate left, right
Reset
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top | Flip horizontal, vertical
Rotate left, right
Reset
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top | PET Fusion is imaging not
supported in FlexView version
v1.2.7. However, this
difference does not raise any
concerns. All of FlexView's
other image display operations
(i.e., those listed in table) are |
| Feature | FlexView Diagnostic | ZeeroMED View
(K200546) | Comments |
| | bottom
Volumetric rendering | bottom
PET fusion
Volumetric rendering | also supported by the predicate
device. |
| Measurement
Functions
Included | Yes | Yes | Same |
| Text Annotations | Yes | Yes | Same |
| Report Generation | Yes | Yes | Same |
| Print Reports | PDF | PDF | Same |
| Export | Yes | Yes | Same |
| Share Function | No | Yes | Share Function not included in
FlexView version v1.2.7.
However, this does not raise
any different questions on
safety of effectiveness of the
device. |
| DICOM
Windowing | Yes | Yes | Same |
| Imaging
Modalities
Included: US, CT,
MRI, X-Ray | Yes | Yes | Same |
| Communications | DICOM | DICOM | Same |
| Operating Systems
Supported | Mac, Windows | Mac, Windows, Linux | The subject device supports
the same operating systems as
the predicate device (Mac and
Windows), with the exception
of Linux. However, this does
not raise any different
questions on safety of
effectiveness of the device. |
| Web Browsers
Supported | Chrome, Edge, Safari | Chrome, Edge, Firefox | The subject device supports
the same web browsers as the
predicate device, except for
Firefox. In addition, the
subject device also supports
Safari. This difference in
supported web browsers does |
| Feature | FlexView Diagnostic | ZeeroMED View (K200546) | Comments |
| | | | not raise any new questions of
safety and effectiveness, and
has been verified through
testing. |
| Mobile Device Support | No | No | Same |
| Store, Display, and Transfer
Medical Images | Yes | Yes | Same |
| Connects to
Existing 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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Image /page/9/Picture/0 description: The image is a square with a dark blue background. In the center of the square is a small white square. Surrounding the white square are four light blue L-shaped figures, one in each corner of the square. The L-shaped figures are oriented so that they appear to be pointing towards the center white square.
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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Image /page/10/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 shapes, each resembling a corner bracket, placed at the corners of an imaginary square centered on the white square. The corner brackets are oriented such that they appear to be framing the central white square.
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.