FEops HEARTguide

DEN200030

FEops NV · granted 2021-09-08 · product code QQI · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“FEops HEARTguide is a computer simulation device which provides a prediction of implant frame deformation (device-tissue interaction) post transcatheter LAAO device implantation.”
AlgorithmFinite Element Analysis (FEA)
source quote (p.2)
“FEops HEARTguide conducts LAAO device implantation simulation via Finite Element Analysis (FEA).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.3)
“Cybersecurity information on both the web-based components and the Simulation Application were provided in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (issued October 2, 2014).”

Validation studies (2)

Retrospective clinical

n=60 cases · 5 site(s)

endpoints: agreement between the predicted and the actual Watchman deformation as measured by the maximum device diameter (Dmax); similarity between the visualization of the simulated deployed device in the anatomy versus the geometry reconstructed from the post-operative CT images

standards: ASME V&V 40-2018: Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices

Reader study (MRMC)

n=180 images

endpoints: similarity between the visualization of the simulated deployed device in the anatomy versus the geometry reconstructed from the post-operative CT images

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: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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 De Novo AI/ML devices in the Cardiovascular 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/DEN200030