Informed Vital Core Application (IVC App)

K241633

Mindset Medical, Inc. · cleared 2024-11-18 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) developed by Mindset Medical.”
Algorithmproprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.
source quote (p.5)
“The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“A cybersecurity threat analysis was conducted using FDA Guidance and AAMI/TIR57:2016/R2019 as a framework. All system components were assessed for potential cybersecurity vulnerabilities. Additional third-party penetration testing was conducted to identify any cybersecurity vulnerabilities in the IVC System. Any detected vulnerabilities were addressed by design and/or testing.”

Validation studies (2)

Bench

n=711 patients

endpoints: accuracy of measured pulse rates within ±3 bpm root mean square error (RMSE) compared to a legally marketed pulse rate measurement device

Prospective clinical

n=67 patients · 6 site(s)

endpoints: accuracy of pulse rates measured with the IVC App to within ±3 beats per minute (BPM) average root mean square (ARMS) of heart rates (HR) measured with the reference ECG device

Reported performance (2 observations)

accuracyas written: “Accuracy (RMSE)”stated without value
source quote (p.8)
“The accuracy of the measured IVC App pulse rates compared to a legally marketed pulse rate measurement device during bench testing demonstrated within ±3 bpm root mean square error (RMSE).”
accuracyas written: “Accuracy (ARMS)”stated without valueCI 95% confidence interval were calculated
source quote (p.9)
“The Average Root Mean Square (ARMS) and its 95% confidence interval were calculated. The hypothesis that the IVC App can measure PR within ± 3 BPM ARMS is accepted.”

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/K241633