(250 days)
Not Found
Yes
The device description explicitly states that "On the server the heart structures will be segmented using a ML based algorithm. Also a ML based semi-automated localization of the Left Atrial Appendage (LAA) will be performed."
No
The device is described as an image management and processing device that facilitates remote viewing and analysis of medical images, and is intended for pre-procedural planning and post-procedural analysis. It is an adjunct tool and not intended to replace a physician's own review, and it does not directly treat or prevent a disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states, "TribusConnect is not intended for diagnostic use on mobile displays." While it facilitates viewing and processing medical images, its primary intent is for pre-procedural planning and post-procedural analysis, and it's an adjunct tool not meant to replace a physician's review. Therefore, it is not primarily a diagnostic device.
Yes
The device is explicitly described as a "cloud-based software application" and a "Saas solution." It relies on standard computing devices for viewing and interaction, but the core functionality and processing are performed by the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- TribusConnect's Function: TribusConnect processes and visualizes medical images (CT scans) that are already acquired from the patient. It does not involve the collection, preparation, or analysis of biological specimens.
- Intended Use: The intended use clearly states it's for "medical image management and processing" and facilitates "remote viewing... of CT images." While it aids in pre-procedural planning and post-procedural analysis, this is based on interpreting existing images, not analyzing biological samples.
- Device Description: The description reinforces that it's a "cloud-based software application that facilitates remote viewing... of CT images."
Therefore, TribusConnect falls under the category of medical image processing and management software, not In Vitro Diagnostics.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources.
TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions.
To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views. Measurements can only be performed on MPR views.
TribusConnect is not intended for diagnostic use on mobile displays.
TribusConnect is not intended to serve as the primary archive for medical imaging data.
TribusConnect is an adjunct tool and is not intended to replace a physician's own review on the images.
The intended patient population is comprised of adult patients (22 years of age and older)
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ
Device Description
TribusConnect consists of the following components:
- . The cloud component performs rendering, provides access to imaging data, ensures secure user authentication, and safeguards data with encryption both in transit and at rest.
- . The web-based viewer application is accessible through standard web browsers on desktops, tablets, and mobile devices.
The device has only one model.
TribusConnect is a cloud-based software application that facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources through a secure internet connection. TribusConnect offers a secure and efficient solution for accessing, reviewing, and visualizing CT images in DICOM format. Measurements can be performed on MPR views. TribusConnect is provided to its users as a Saas solution, TribusMed will be in control of installation, configuration, updates etc.
TribusConnect can be used in healthcare facilities, hospitals, and remote locations, including home environments, when accessed by authorized users through a secure internet connection.
CT scans can be uploaded to the server and will be de-identified before the upload. On the server the heart structures will be segmented using a ML based algorithm. Also a ML based semi-automated localization of the Left Atrial Appendage (LAA) will be performed.
All rendering of image data is done on the server te results can be viewed on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection.
Images can be rendered as Volume rendering, segmentations, simulated fluoroscopy, endo view, MIP or MPR. The user can interact with the data like zooming, rotating, changing the window. On the MPR views measurements can be performed.
The device's cloud infrastructure and encryption protocols ensure data protection and compliance with security standards. protection and compliance with security standards. The client operates on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection and requires no dedicated energy source as it leverages the user's device power.
TribusConnect is a software application that does not involve physical materials with patient contact and operates through cloud infrastructure and standard web browsers. TribusConnect is supported in the following configurations:
- . PC: Windows with Edge or Chrome
- Mac: MacOS with Safari or Chrome
- . iPad: iPadOS with Safari or Chrome
- . iPhone: iOS with Safari or Chrome
- . Tablet: Android with Chrome
- . Smartphone: Android with Chrome
Note: TribusConnect is not intended for diagnostic use on mobile displays.
For interacting with TribusConnect the following internet bandwidth is recommended: Upload: 5 Mbps
Download: 20 Mbps
The software provides the following Manual Quantitative Imaging Functions. These measurements can be used on the MPR views only. The accuracy of all measurements is within 5% of the true value.
| Measurement | Results |
|---|---|
| Distance measurement | Distance between two points in mm |
| (Open) spline | Distance over a non-straight trajectory in mm |
| Closed spline | Area in mm², perimeter, area derived diameter, perimeter derived diameter, min diameter and max diameter all in mm |
| Angle | Angle in degrees |
| Hounsfield probe (3D Marker) | The HU (Hounsfield unit) of the underlying pixel |
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT DICOM data
Anatomical Site
Heart structures, Left Atrial Appendage (LAA)
Indicated Patient Age Range
The intended patient population is comprised of adult patients (22 years of age and older)
Intended User / Care Setting
Intended User: trained healthcare professionals, including but not limited to radiologists, physicians, nurses, and technicians.
Care Setting: healthcare facilities, hospitals, and remote locations, including home environments, when accessed by authorized users through a secure internet connection.
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
Sample size: 100 CTA volumes
Data source: collected from 14 sites across the United States. The data, retrospectively gathered, was anonymized before being shared with TribusMed. The sites providing data for the training dataset are different from the validation dataset, that is, no sites used for training are used for validation. Each dataset is acquired form an unique patient.
Annotation protocol: Validation of Heart segmentation is performed by 2 US board certified radiologists who qualitatively evaluated the performance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Software Verification, Cybersecurity Testing, Validation of Machine Learning Algorithms (Heart Segmentation and LAA Localization).
Sample Size: For ML algorithm validation, 100 CTA volumes were used from 100 unique patients.
Standalone Performance:
- Heart Segmentation:
- 100% of cases bone removal correct
- 99% of cases each segmented structure is clearly visible
- 100% of cases the rendered view of the heart is clinically usable
- LAA Localization:
- 97% of the cases are within 10mm of the landing zone contour center as computed by the predicate device (TruPlan).
- Average distance was 4.40 mm, and its standard deviation was 2.74 mm.
- 95 out of 98 cases (97%) had a distance
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2025
TribusMed Beheer BV Johan Vogelaar COO Oude Vest 9 Breda, 4811HR Netherlands
Re: K242166
Trade/Device Name: TribusConnect Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: July 24, 2024 Received: February 24, 2025
Dear Johan Vogelaar:
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"
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(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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).
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Sincerely,
Jessica Lamb
Jessica Lamb, PhD 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
Enclosure
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Indications for Use
Submission Number (if known)
K242166
Device Name
TribusConnect
Indications for Use (Describe)
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources.
TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions.
To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views. Measurements can only be performed on MPR views.
TribusConnect is not intended for diagnostic use on mobile displays.
TribusConnect is not intended to serve as the primary archive for medical imaging data.
TribusConnect is an adjunct tool and is not intended to replace a physician's own review on the images.
The intended patient population is comprised of adult patients (22 years of age and older)
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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TribusConnect 510(k) Summary (K242166)
The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act 1990 and 21 CFR 807.92.
Date: March 30, 2025
Contact details
Applicant Name: TribusMed Beheer BV Applicant Address: Oude Vest 9 Breda 4811HR Netherlands Applicant Contact Telephone: +31 6 36192511 Applicant Contact: Johan Vogelaar Applicant Contact Email: johan.vogelaar@tribusmed.com
Device
Device Trade Name: TribusConnect Classification Name: Medical image management and processing system Common Name: Automated Radiological Image Processing Software Regulation Number: 21 CFR 892.2050 Product Code(s): QIH, LLZ
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K141061 | RemotEye Viewer | LLZ |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | QIH |
Device Description Summary
TribusConnect consists of the following components:
- . The cloud component performs rendering, provides access to imaging data, ensures secure user authentication, and safeguards data with encryption both in transit and at rest.
- . The web-based viewer application is accessible through standard web browsers on desktops, tablets, and mobile devices.
The device has only one model.
TribusConnect is a cloud-based software application that facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources through a secure internet connection. TribusConnect offers a secure and efficient solution for accessing, reviewing, and visualizing CT images in DICOM format. Measurements can be performed on MPR views. TribusConnect is
Image /page/4/Picture/16 description: The image contains the logo for Tribus Med. The logo consists of a circular graphic on the left and the text "Tribus Med" on the right. The circular graphic is made up of three red dots connected by curved lines. The text "Tribus Med" is in a teal color.
5
provided to its users as a Saas solution, TribusMed will be in control of installation, configuration, updates etc.
TribusConnect can be used in healthcare facilities, hospitals, and remote locations, including home environments, when accessed by authorized users through a secure internet connection.
CT scans can be uploaded to the server and will be de-identified before the upload. On the server the heart structures will be segmented using a ML based algorithm. Also a ML based semi-automated localization of the Left Atrial Appendage (LAA) will be performed.
All rendering of image data is done on the server te results can be viewed on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection.
Images can be rendered as Volume rendering, segmentations, simulated fluoroscopy, endo view, MIP or MPR. The user can interact with the data like zooming, rotating, changing the window. On the MPR views measurements can be performed.
The device's cloud infrastructure and encryption protocols ensure data protection and compliance with security standards.
protection and compliance with security standards. The client operates on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection and requires no dedicated energy source as it leverages the user's device power.
TribusConnect is a software application that does not involve physical materials with patient contact and operates through cloud infrastructure and standard web browsers. TribusConnect is supported in the following configurations:
- . PC: Windows with Edge or Chrome
- Mac: MacOS with Safari or Chrome
- . iPad: iPadOS with Safari or Chrome
- . iPhone: iOS with Safari or Chrome
- . Tablet: Android with Chrome
- . Smartphone: Android with Chrome
Note: TribusConnect is not intended for diagnostic use on mobile displays.
For interacting with TribusConnect the following internet bandwidth is recommended: Upload: 5 Mbps
Download: 20 Mbps
Image /page/5/Picture/17 description: The image shows the logo for Tribus Med. The logo consists of a circular symbol on the left and the text "Tribus Med" on the right. The circular symbol is made up of three red dots connected by curved lines. The text "Tribus Med" is in a teal color.
6
The software provides the following Manual Quantitative Imaging Functions. These measurements can be used on the MPR views only. The accuracy of all measurements is within 5% of the true value.
| Measurement | Results |
|---|---|
| Distance | |
| measurement | Distance between two points in mm |
| (Open) spline | Distance over a non-straight trajectory in mm |
| Closed spline | Area in mm², perimeter, area derived diameter, perimeter |
| derived diameter, min diameter and max diameter all in mm | |
| Angle | Angle in degrees |
| Hounsfield probe (3D | |
| Marker) | The HU (Hounsfield unit) of the underlying pixel |
Intended Use/Indications for Use
Intended Use
TribusConnect is a cloud-based DICOM viewer designed for medical professionals to securely access, review, manipulate, measure and visualize DICOM images. The software is intended to be used by trained healthcare professionals, including but not limited to radiologists, physicians, nurses, and technicians.
Indications for use
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources.
TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions.
To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views.
Measurements can only be performed on MPR views.
TribusConnect is not intended for diagnostic use on mobile displays.
TribusConnect is not intended to serve as the primary archive for medical imaging data. TribusConnect is an adjunct tool and is not intended to replace a physician's own review on the images.
The intended patient population is comprised of adult patients (22 years of age and older)
Image /page/6/Picture/13 description: The image shows the logo for Tribus Med. The logo consists of a circular graphic on the left and the text "Tribus Med" on the right. The graphic is made up of three red dots connected by curved lines, forming a circular shape. The text "Tribus Med" is written in a teal color.
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Comparison with predicate devices:
The detailed analysis of the subject device and the primary and secondary predicate devices (shown in the Device comparison table) demonstrates that the subject device is substantially equivalent in indications for use / intended use, technological characteristics, functionality, and operating principles with the primary predicate (K141061) and with the secondary predicate (K222593). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological characteristics are not applicable since the subject device and both predicate devices are software as a medical device application with no tangible component interfacing with the body.
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
|---------------------|------------------------------------------------------|------------------------------------------------|---------------------------------------------------------|
| Device name | TribusConnect | RemotEye Viewer | TruPlan Computed
Tomography (CT)
Imaging Software |
| Device manufacturer | TribusMed BV | NeoLogica s.r.l. | Circle Cardiovascular
Imaging Inc. |
| 510(k) number | K242166 | K141061 | K222593 |
| Regulation name | Medical image
management and
processing system | Picture archiving and
communications system | Medical image
management and
processing system |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product code | QIH | LLZ | QIH, LLZ |
| Regulatory Class | II | II | II |
Device comparison table
8
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | TribusConnect is a cloud-
based DICOM viewer
designed for medical
professionals to securely
access, review,
manipulate, measure and
visualize DICOM images.
The software is intended
to be used by trained
healthcare professionals,
including but not limited
to radiologists,
physicians, nurses, and
technicians. | The RemotEye Viewer
software product is
intended to be used as a
functional, web based
medical image viewer to
download, review,
interpret, manipulate,
visualize and print
medical multi-modality
image data in DICOM
format also stored in
remote locations with
respect to the viewing
site. When interpreted by
a trained physician, the
medical images
displayed by RemotEye
Viewer can be used as an
element for diagnosis.
Typical users of
RemotEye Viewer are
trained professionals,
including but not limited
to radiologists,
physicians, nurses and
technicians. | TruPlan enables
visualization and
measurement of
structures of the heart
and vessels for:
- Pre-procedural
planning and sizing for
the left atrial appendage
closure (LAAC)
procedure - Post-procedural
evaluation for the LAAC
procedure |
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
| Indications for use | TribusConnect is a
medical image
management and
processing device which
facilitates remote viewing
on different locations of
CT images stored in
DICOM format, allowing
healthcare professionals
to access, review,
manipulate, measure and
visualize
simulated patient data
from different sources.
TribusConnect is suitable
for, but not limited to, pre-procedural planning of
cardiac interventions and
post procedural analysis
of cardiac interventions.
To facilitate the above,
TribusConnect uses CT
DICOM data to output
volume renderings, ML-based heart
segmentation, a
simulated fluoroscopy
view, endo views, MIP and
MPR views.
Measurements can only
be performed on MPR
views.
TribusConnect is not
intended for diagnostic
use on mobile displays.
TribusConnect is not
intended to serve as the | The RemotEye Viewer
software product is
intended to be used as a
functional, web based
medical image viewer to
download, review,
interpret, manipulate,
visualize and print
medical multi-modality
image data in DICOM
format also stored in
remote locations with
respect to the viewing
site. When interpreted by
a trained physician, the
medical images
displayed by RemotEye
Viewer can be used as an
element for diagnosis.
Typical users of
RemotEye Viewer are
trained professionals,
including but not limited
to radiologists,
physicians, nurses and
technicians. | TruPlan enables
visualization and
measurement of
structures of the heart
and vessels for:
- Pre-procedural
planning and sizing for
the left atrial appendage
closure (LAAC)
procedure - Post-procedural
evaluation for the LAAC
procedure |
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
| | primary archive for
medical imaging data.
TribusConnect is an
adjunct tool and is not
intended to replace a
physician's own review on
the images.
The intended patient
population is comprised
of adult patients (22 years
of age and older) | | |
| Patient population | The intended patient
population is comprised
of adult patients (22 years
of age and older) | No limitations in 510(k) or
IFU
Similar, The fact that a
portion of the population
is not within the scope of
TribusConnect does not
introduce new risks. | TruPlan's intended
patient population is
comprised of adult
patients.
Same |
| Input data | CT (In DICOM format) | Multi modality DICOM
compliant (Including CT)
Similar, more supported
modalities | CT (In DICOM format)
Same |
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
| Patient study management | • Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search | • Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search | • Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search |
| | | Same | Same |
| Measurement functionality | • Distance (length, diameter, perimeter)
• Area
• Angle
• Signal intensity | Advanced distance, area, angle and density measurement tools (including SUV for PET images), plus several graphical annotation tools.
Measurement of CTR (Cardio-Thoracic Ratio) also supported. | • Distance (length, diameter, perimeter)
• Area
• Angle
• Signal intensity
• Coordinates |
| | | Same | Same |
| Visualization/rendering | • 2D
• 3D
• 4D
• MPR
• Annotations
• Segmented 3D volume | • 2D
• 3D
• MPR / MIP / MinIP /AvgIP
• Annotations
Similar. No information could be found whether 4D is supported, since 4D as implemented in TribusConnect and TruPlan is a sequence of 3D images played in a movie, this will not introduce a new risk | • 2D
• 3D
• 4D
• MPR
• MIP
• Annotations
• Segmented 3D volume |
| | | | Same |
| Segmentations | ML based segmentation of all heart chambers, aorta, pulmonary trunk and vena cava | No segmentation | ML based segmentation left atrium, left ventricle, left atrial appendage and the aorta (Left |
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
| | | | heart) |
| | | | Manual sculpting |
| | | | Similar, The same underlying technique is used the algorithm in TribusConnect is trained to identify more structures, this does not introduce new risks. Absence of the sculpting feature does not introduce new risks. |
| Left atrial appendage
localization | Semi-Automated
Localization of LAA
appendage | No such functionality | Localization of LAA
appendage
Similar, since TribusConnect does not automatically suggest measurements like TruPlan, no new risks are introduced. |
| Session saving | Analysis is stored in a
"Saved session" | DICOM presentation
states and Key note
images
Similar, the saved sessions in TribusConnect also contain information about the orientation of the MPR planes and volumes, this does not introduce new risks | Analysis is saved in a
saved session.
Same |
| Collaboration | Shared sessions | Cloud-based peer-to-peer image sharing functionalities. | Sessions are saved on a central location and available for other users. |
| | TribusConnect
(Subject device) | RemotEye Viewer
(Primary Predicate) | TruPlan
(Secondary Predicate) |
| | | Same | Similar, work can be
shared via a saved
session, but no “live”
image sharing, this does
not introduce new risks |
| Upload of data | File system based upload
of DICOM files. | DICOM protocol and
import from disk | Supports DICOM
connectivity and file-
system based upload of
image data. |
| | | Same | Same |
| Storage of data | Cloud | Cloud | Laptop, on-premise
server |
| | | Same | Similar, an on-premise
server is not necessarily
accessible via the
internet, the risks
introduced by the cloud
component are handled
in the cyber security risk
assessment and
deemed acceptable |
| Technical environment | Cloud based zero
footprint viewer, users
can access the viewer
through a standard web
browser on their
desktops, laptops, or
mobile devices. | RemotEye Viewer is
compatible with
Windows, Mac OS X and
Linux clients.
Similar, TribusConnect is
supported on more
devices, the possible
risks introduced by this
are evaluated as part of
the risk management
activities and deemed
acceptable | Windows/Apple based
desktop/laptop
application.
Similar, TribusConnect
is supported on more
devices and cloud
based, the possible risks
introduced by this are
evaluated as part of the
risk management
activities and deemed
acceptable |
Image /page/8/Picture/1 description: The image contains the logo for Tribus Med. The logo consists of a circular graphic on the left and the text "Tribus Med" on the right. The circular graphic is made up of three red dots connected by curved lines, forming a circle. The text "Tribus Med" is in a teal color.
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ibus Med
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Image /page/10/Picture/1 description: The image contains the logo for Tribus Med. The logo consists of a circular design on the left, made up of three red dots connected by curved lines. To the right of the circular design is the text "Tribus Med" in a teal color. The text is in a sans-serif font and is slightly bolded.
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Image /page/11/Picture/1 description: The image shows the logo for Tribus Med. The logo consists of a circular design on the left, made up of three red dots connected by curved lines. To the right of the circular design is the text "Tribus Med" in a teal color. The text is in a sans-serif font and appears to be the name of the company or organization.
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Image /page/12/Picture/2 description: The image shows the logo for Tribus Med. The logo consists of a circular symbol on the left and the text "Tribus Med" on the right. The circular symbol is made up of three red dots connected by curved lines. The text "Tribus Med" is in a teal color.
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Predicate device discussion
Indications for Use Comparison
TribusConnect and the primary predicate device, RemotEye Viewer (K141061), share the same indications for use, both facilitating web-based image viewing. While TribusConnect supports fewer imaging modalities and has a more limited intended patient population, performance testing confirmed that these differences do not compromise safety or effectiveness. Validation studies demonstrated equivalent diagnostic image quality, usability, and accuracy in supported modalities, ensuring consistent clinical performance. Therefore, these differences do not introduce new risks.
The secondary predicate device, TruPlan (K222593), is specifically intended for LAAC procedures. TribusConnect supports a broader range of cardiac interventions using similar imaging and measurement techniques, with a consistent patient population. Validation of the algorithm confirmed equivalent performance, and no new risks were identified. Therefore, the intended use of TribusConnect is very similar to that of TruPlan, and these differences do not introduce new risks.
Technological Comparison
Visualization Techniques and Measurements:
Both TribusConnect and RemotEye Viewer offer the same range of visualization techniques and measurements. This suggests parity in their basic functionalities for viewing medical imaging data.
Web-based Platforms:
Both TribusConnect and RemotEye Viewer are web-based viewers, meaning they can be accessed remotely via browsers.
Modalities Supported:
TribusConnect supports only CT scans, while RemotEye Viewer supports multiple modalities. This provides more flexibility with RemotEye Viewer but does not introduce new risks according to verification and validation tests.
Heart Segmentation:
TruPlan uses machine learning to segment four heart structures, while TribusConnect uses ml to identify seven. Despite the difference in the number of structures identified, validation shows that TribusConnect does not introduce any new safety or performance issues.
LAA Localization Tool:
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The LAA localization method in TruPlan is designed for initiating a landingzone measurement. In TribusConnect, the method is used as a navigation tool only. This distinction does not introduce new risks, reinforcing the system's safety.
Overall Evaluation of the technological comparison :
Both systems maintain similar levels of safety and performance. TribusConnect does not introduce new technological characteristics, staying within previously validated boundaries. Its additional functionalities, like supporting more heart structures does not introduce new risks. Therefore, TribusConnect offers comparable performance and safety without new technological changes.
Regulatory History
Currently, no warning letters, product recalls, or reports in the MAUDE database have been identified for either RemotEye Viewer or TruPlan.
Conclusion of the Predicate device discussion
Based on the substantial similarities in intended use, technical characteristics, and the use of equivalent segmentation techniques, along with the absence of regulatory concerns for the predicate devices, TribusConnect is deemed substantially equivalent. It is concluded that TribusConnect does not introduce any new issues and is as safe and effective as the predicate devices, RemotEye Viewer and TruPlan.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Performance testing was conducted to verify compliance with specified design requirements in accordance with IEC 62304:2015, ISO 14971:2019, and NEMA 3.1-3.20 (2016) DICOM standard.
Software Verification:
A test plan was created and executed to ensure that all requirements were implemented according to specifications, and all test cases passed successfully. Manual measurements were thoroughly validated using phantom studies, demonstrating that all performance criteria were met, with measurement results falling within 5% of the true value.
Verification testing was conducted to confirm the device's specifications and performance in accordance with the FDA guidance documents:
- Content of Premarket Submissions for Device Software Functions
- . Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- . Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
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Cybersecurity Testing:
A penetration test was conducted by an external company, and the cybersecurity assessment was successfully completed, validating the system's security measures and resilience. No issues classified as medium or higher were identified. Cybersecurity testing was performed in accordance with the FDA guidance document:
- Cybersecurity in Medical Devices: Quality System Considerations and Content . of Premarket Submissions
Validation of the machine learning based algorithms:
For the validation of the algorithms, 100 CTA volumes were collected from 14 sites across the United States. No specific patient selection criteria were applied, and the volumes from each site generally consisted of consecutive cases. The data, retrospectively gathered, was anonymized before being shared with TribusMed. The sites providing data for the training dataset are different from the validation dataset, that is, no sites used for training are used for validation. Each dataset is acquired form an unique patient.
Details dataset used
- Patients - 100
- Male 59 ●
- Female 40 ●
- Unknown 1 ●
- Age (v) 76 (52 91) .
- Slice thickness (mm) 0.63 (0.50 2.50) ●
- Slice count 303 (106 868) ●
- . In-plane resolution (mm) - 0.49 (0.30 - 0.87)
- Field Of View (mm) 160 (103 347) ●
- Tube potential (kVp) - 120 (70 - 135)
- X-ray tube current (mA) 571 (101 2442) ●
- LAA morphology
- o Chicken Wing 42
- o Cactus 42
- o Windsock 14
- LAA Thrombus / Bad Filling 18 .
- Manufacturers:
- o Toshiba /Canon 12
- Philips 6 o
- Siemens 42 o
- o GE 38
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Validation of Heart segmentation
Acceptance criteria Heart segmentation:
- . In at least 80% of cases bone removal should performed correctly
- In at least 80% of cases each segmented structure should be clearly visible .
- . In at least 80% of cases the rendered view of the heart should be clinically usable
Validation of Heart segmentation is performed by 2 US board certified radiologists who qualitatively evaluated the performance.
Validation results Heart segmentation:
- . 100% of cases bone removal correct
- 99% of cases each segmented structure is clearly visible
- . 100% of cases the rendered view of the heart is clinically usable
Due to this low failure rate, a subgroup analysis would not provide meaningful insight
Validation of LAA Localization
Acceptance criteria LAA Localization:
- . LAA localized within 10mm of the landing zone contour center as computed by the predicate device, in 95% of all cases, with a confidence of 95% and a statistical power of 80%
Validation of the LAA localization feature is performed by comparing the results with the predicate device TruPlan( K222593)
Acceptance criteria LAA Localization:
- 97% of the cases are within 10mm of the landing zone contour center as ● computed by the predicate device
Validation results of the LAA localization feature:
Average distance was 4.40 mm, and its standard deviation was 2.74 mm. 95 out of 98 cases (97%) had a distance