CorVista System with PH Add-On

K233666

Analytics for Life, Inc. · cleared 2024-04-05 · product code SAT · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm.”
Algorithmstatic machine learning-based detection algorithm derived from calculated VCG and PPG features and patient demographics
source quote (p.5)
“The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm. The architecture of the CorVista Base system allows for integration with indication-specific “Add-Ons” which perform data analysis using a machine learned detection algorithm to indicate the likelihood of specific diseases at point of care.”
Adaptive (vs locked)No
source quote (p.5)
“The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: acceptable performance to the protocols tested; acceptance criteria were met

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 80601-2-61, IEC 60259, IEC 62133, AIM 7351731, ANSI IEEE C63.27, FCC 47CFR Part 15 Subpart C, ISO 10993, ISO 10993-5:2009, ISO 10993-10:2010, AAMI TIR 12: 2020, AAMI TIR 30: 2011, ASTM F3208-20, ASTM F3293-18, ASTM F1980

Prospective clinical

n=386 patients

endpoints: diagnostic performance (sensitivity, specificity, NPV, AUC-ROC) for elevated mPAP; performance (AUC-ROC, sensitivity) for mPAP > 21 mmHg

Reported performance (6 observations)

sensitivity0.82
source quote (p.13)
“The diagnostic performance of the CorVista System in this broad population was demonstrated to be 82% sensitivity and 92% specificity, NPV of>99%, with a 0.95 AUC-ROC.”
specificity0.92
source quote (p.13)
“The diagnostic performance of the CorVista System in this broad population was demonstrated to be 82% sensitivity and 92% specificity, NPV of>99%, with a 0.95 AUC-ROC.”
aurocas written: “auc”0.95
source quote (p.13)
“The diagnostic performance of the CorVista System in this broad population was demonstrated to be 82% sensitivity and 92% specificity, NPV of>99%, with a 0.95 AUC-ROC.”
npvas written: “NPV”stated without valueCI >99%
source quote (p.13)
“The diagnostic performance of the CorVista System in this broad population was demonstrated to be 82% sensitivity and 92% specificity, NPV of>99%, with a 0.95 AUC-ROC.”
aurocas written: “AUC-ROC (mPAP > 21 mmHg)”0.93
source quote (p.13)
“Results of this performance evaluation demonstrated that the PH algorithm at this disease threshold has an AUC-ROC of 0.93, and a sensitivity of 0.78, which passed the pre-specified secondary endpoint.”
sensitivityas written: “Sensitivity (mPAP > 21 mmHg)”0.78
source quote (p.13)
“Results of this performance evaluation demonstrated that the PH algorithm at this disease threshold has an AUC-ROC of 0.93, and a sensitivity of 0.78, which passed the pre-specified secondary endpoint.”

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 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/K233666