TribusConnect

K242166

TribusMed Beheer BV · cleared 2025-03-31 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“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. 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.”
AlgorithmML-based heart segmentation, ML based semi-automated localization of the Left Atrial Appendage (LAA)
source quote (p.6)
“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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.17)
“A penetration test was conducted by an external company, and the cybersecurity assessment was successfully completed, validating the system's security measures and resilience.”

Validation studies (2)

Retrospective clinical

n=100 patients · 14 site(s)

endpoints: 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

standards: IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standard

Retrospective clinical

n=100 patients · 14 site(s)

endpoints: 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%

standards: IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standard

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242166