HeartFocus (V.1.1.1)

K242807

Deski · cleared 2025-04-04 · product code QJU · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The HeartFocus software is a radiological computer-assisted acquisition guidance system that provides real-time user guidance during echocardiography to assist the user in acquiring anatomically standard diagnostic-quality 2D echocardiographic views. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. HeartFocus is an application that operates entirely offline, without requiring a cloud server to provide its functionalities. All collected medical data is stored locally on the tablet. This data is never transferred to a server controlled by DESKi. HeartFocus uses artificial intelligence (AI) to emulate the expertise of sonographers in positioning the probe on the patient's chest and in identifying and recording diagnostic-quality clips.”
AlgorithmArtificial intelligence (AI) and machine learning model, including deep learning based algorithms, to emulate the expertise of sonographers in positioning the probe on the patient's chest and in identifying and recording diagnostic-quality clips. The guidance UI is generated by a machine learning model that infers the probe's position relative to the target position.
source quote (p.6)
“HeartFocus uses artificial intelligence (AI) to emulate the expertise of sonographers in positioning the probe on the patient's chest and in identifying and recording diagnostic-quality clips. The guidance UI is generated by a machine learning model that infers the probe's position relative to the target position, i.e. that would provide diagnostic-quality images. Both systems apply deep learning based algorithms to emulate the expertise of a sonographer by providing real-time guidance on how to position the transducer on the patient's body.”
Adaptive (vs locked)No
source quote (p.21)
“The modification is limited to retraining with additional data without changing the models' architecture or training procedure.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

n=31 other

endpoints: demonstrate that the HeartFocus user interface is safe and effective for the intended users, uses, and use environments

standards: FDA Guidance Document, « Applying Human Factors and Usability Engineering to Medical Devices », IEC 62366 1:205 standard

Standalone

n=290 patients

endpoints: accurately detect anatomical structures of the heart in ultrasound images to indicate whether they can be used to guide the user; maximize the likelihood of capturing high-quality records; provide a relevant estimate of recording quality; automatically record clips identified to be of diagnostic quality by experts

Prospective clinical

n=240 patients · 2 site(s)

endpoints: Qualitative visual assessment of left ventricular (LV) size; Qualitative visual assessment of LV function; Qualitative visual assessment of right ventricular (RV) size; Qualitative visual assessment of the presence of non-trivial pericardial effusion

standards: ACEP scale (ACEP ≥ 3, Liu, R. B. et al. Emergency Ultrasound Standard Reporting Guidelines)

Reported performance (5 observations)

specificity0.997
source quote (p.20)
“99.7% of the clips recorded with the “Auto record” feature were of diagnostic quality, demonstrating the high specificity of this feature.”
agreement_kappaas written: “Cohen's kappa score for Diagnostic-quality view detection”0.699CI [0.673, 0.724]
source quote (p.15)
“Cohen's kappa scores range from 0.699 [0.673, 0.724] to 0.873 [0.861, 0.884], meeting the success criteria of Cohen's kappa score > 0.6 on the lower bound of the 95% CI for each reference view.”
ppvas written: “Positive Predictive Value (PPV) for Live Guidance”0.81CI [0.804, 0.816]
source quote (p.15)
“Guidance cues PPV ranges from 0.810 [0.804, 0.816] to 0.953 [0.951, 0.955], satisfying the success criteria of PPV > 0.8 on the lower bound of the 95% CI for each reference view.”
ppvas written: “Positive Predictive Value (PPV) for Auto Record”0.846CI [0.665, 0.938]
source quote (p.15)
“While using the Auto record feature solely, the PPV ranges from 0.846 [0.665, 0.938] to 1.000 [0.908, 1.000], meeting the success criteria of PPV > 0.6 on the lower bound of the 95% CI and PPV > 0.8 on the point estimate for each reference view.”
ppvas written: “Positive Predictive Value (PPV) for Auto Record and Best-Effort Record”0.816CI [0.666, 0.908]
source quote (p.15)
“While using both the Auto record and Best-Effort record, the PPV ranges from 0.816 [0.666, 0.908] to 1.000 [0.914, 1.000].”

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
0
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/K242807