Cardiovascular · 510(k) · 2019
Biovitals Analytics Engine
Biofourmis Singapore Pte. Ltd. Cleared by FDA on 15 August 2019 under submission K183282, product code PLB (multivariate vital signs index). What FDA's record says, in FDA's words.
Device record · K183282
- Device. Biovitals Analytics EngineDEVICE
- Company. Biofourmis Singapore Pte. Ltd (SG)COMPANY
- Decision. 15 August 2019, 510(k), substantially equivalent (traditional review); received 26 November 2018DECISION
- Panel. CardiovascularPANEL
- Product code. PLB, Multivariate Vital Signs IndexCODE
- Regulation. 21 CFR 870.2300, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient’s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient’s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decis ions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population. Summary Comparison to Predicate: The following tables provide a summary of substantial equivalence between the subject device and the cited predic ate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or […]
The product code's definition, from FDA's classification record. Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PLB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PLB, in Cardiovascular, from Biofourmis Singapore Pte. Ltd, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.