Biovitals Analytics Engine

K183282

Biofourmis Singapore Pte. Ltd · cleared 2019-08-15 · product code PLB · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring.”
Algorithmautomated proprietary algorithm to analyze data and generate Biovitals Index; Non-linear combination of vital parameters
source quote (p.4)
“An automated proprietary algorithm to analyze data and generate Biovitals Index.”
Adaptive (vs locked)Yes
source quote (p.5)
“The baseline is initially established using data from the first 24 hours and updated periodically as new data is received.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=50 patients · 1 site(s)

endpoints: evaluate the performance of the Biovitals Index

standards: AAMI ANSI IEC 62304:2015, Medical device software – Software life cycle processes, General Principles of Software Validation; Final Guidance for Industry and FDA Staff” (January 2002), IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Application of usability engineering to medical devices

Reported performance (1 observation)

agreement_kappaas written: “Lower bound of 95% confidence interval of the positive percent agreement (PPA)”stated without valueCI > 0.7
source quote (p.10)
“a lower bound of the 95% confidence interval of the positive percent agreement (PPA) greater than 0.7.”

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/K183282