Who is the manufacturer of TribusConnect?

Tribusmed Beheer BV filed the 510(k) submission for TribusConnect (K242166).

What is the FDA product code for TribusConnect?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TribusConnect?

510(k) clearance (submission type: Traditional).

Does TribusConnect use AI or machine learning?

Yes. TribusConnect (K242166) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for TribusConnect?

RemotEye Viewer (K141061); TruPlan Computed Tomography (CT) Imaging Software (K222593).

Who can help prepare an FDA 510(k) submission like TribusConnect?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like TribusConnect get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

TribusConnect

K242166 · Tribusmed Beheer BV · QIH · Mar 31, 2025 · Radiology

Device Facts

Record ID	K242166
Device Name	TribusConnect
Applicant	Tribusmed Beheer BV
Product Code	QIH · Radiology
Decision Date	Mar 31, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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.

Device Story

Cloud-based medical image management/processing software; enables remote viewing/manipulation of CT DICOM data. Inputs: CT DICOM files. Processing: Server-side ML-based heart segmentation (all chambers, aorta, pulmonary trunk, vena cava) and semi-automated Left Atrial Appendage (LAA) localization; volume rendering; simulated fluoroscopy; endo views; MIP/MPR generation. Outputs: Visualizations and quantitative measurements (distance, area, angle, HU) on MPR views. Used in hospitals/clinics/home by physicians/nurses/technicians via web browsers. Facilitates pre/post-procedural planning for cardiac interventions. Benefits: Enables remote access to cardiac imaging data for clinical decision-making support.

Clinical Evidence

No clinical studies performed. Evidence based on bench testing and retrospective validation of ML algorithms using 100 CTA volumes from 14 sites. Heart segmentation validation (n=100) by 2 board-certified radiologists: 100% bone removal success, 99% structure visibility, 100% clinical usability. LAA localization validation (n=98) compared to TruPlan: 97% of cases within 10mm of landing zone center (mean 4.40mm). Software verification confirmed measurement accuracy within 5% of true value.

Technological Characteristics

Cloud-based SaaS; zero-footprint web viewer. Supports CT DICOM data. ML-based segmentation and LAA localization. Connectivity: Secure internet connection (recommended 5 Mbps upload/20 Mbps download). Standards: IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM. No physical patient-contact materials.

Indications for Use

Indicated for adult patients (22+ years) to facilitate remote viewing of CT images in DICOM format. Used for pre-procedural planning and post-procedural analysis of cardiac interventions. Provides volume renderings, ML-based heart segmentation, simulated fluoroscopy, endo views, MIP, and MPR views. Measurements are restricted to MPR views. Not for diagnostic use on mobile displays, not a primary archive, and not a replacement for physician review.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

RemotEye Viewer (K141061)
TruPlan Computed Tomography (CT) Imaging Software (K222593)

Related Devices

K250330 — 3mensio Workstation · Pie Medical Imaging BV · Nov 3, 2025
K200515 — syngo.CT Cardiac Planning · Siemens Medical Soultions USA, Inc. · Mar 25, 2020
K242500 — LARALAB · Laralab GmbH · Apr 16, 2025
K240839 — OpenRad Cloud · Openrad Services Uk, Ltd. · Apr 24, 2024
K203744 — Arterys MICA · Arterys, Inc. · Mar 14, 2022

Submission Summary (Full Text)

{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" {1}------------------------------------------------ 2 (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ #### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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. {7}------------------------------------------------ # 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. {9}------------------------------------------------ ## Page 6 of 15 # ibus Med {10}------------------------------------------------ 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. {11}------------------------------------------------ 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. {12}------------------------------------------------ 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. {13}------------------------------------------------ Image /page/13/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. {14}------------------------------------------------ # 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 visual…