PVAD IQ Software

K252235

Ultrasight , Ltd. · cleared 2025-12-18 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“PVAD IQ is a Software as a Medical Device (SaMD) solution designed to support clinicians in the positioning of Percutaneous Ventricular Assist devices (PVADs) through ultrasound image-based assessment.”
Algorithmmachine learning model (MLM) based software, Deep Convolutional Neural Networks for Landmark Detection and Classification
source quote (p.5)
“The PVAD IQ software is a machine learning model (MLM) based software, that operates on ultrasound clips (as the system input) and provides two outputs with regards to PVAD patients: 1. Landmark identification and measurement - provides the two landmarks position detection, and computation of the mean distance between the two landmarks- the aortic annulus and the PVAD inlet. 2. Acceptability classification, which is a binary classification of ultrasound clips that are "acceptable” or “non-acceptable", in terms of visibility of the two landmarks. A clip is defined as acceptable when both landmarks are simultaneously visible in a manner suitable for quantitative imaging. and Deep Convolutional Neural Networks for Landmark Detection and Classification”
Adaptive (vs locked)No
source quote (p.6)
“PVAD IQ software is an ultrasound image processing software implementing non-adaptive machine learning algorithms trained with clinical data and intended for automated analysis of transthoracic echocardiography (TTE) using ultrasound clips.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.9)
“The device underwent comprehensive software validation and cybersecurity testing in accordance with the FDA's Guidance "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".”

Validation studies (1)

Retrospective clinical

n=186 patients

endpoints: Distance measurement (MAE); Acceptability classification (Cohens kappa); Landmark detection (AUC); Landmark position (MAE)

Reported performance (2 observations)

aurocas written: “auc”0.92CI 0.9-0.94
source quote (p.8)
“Landmark detection of inlet and aortic annulus requirement: AUC above 0.8. result: Inlet: 0.92 (0.9-0.94). Annulus: 0.98 (0.95, 1)”
agreement_kappaas written: “Acceptability classification Cohens kappa”0.71CI 0.66-0.75
source quote (p.8)
“Acceptability classification requirement: Cohens kappa above 0.6. result: 0.71 with a 95% CI of (0.66-0.75)”

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/K252235