# K142512: Personalized Physiology Analytics Engine software

- Pathway: 510(k) (Traditional)
- Applicant: Vgbio, Inc (Dba Physiq)
- Decided: Jun 11, 2015 after 276 days
- Product code: PLB (Multivariate Vital Signs Index)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 36 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053112: Biosign, Oxford Biosignals Limited (2006) Summary page 5.
- K081140: Visensia, Obs Medical (2008) Summary page 5.

## Most influential descendants
- K183282: Biovitals Analytics Engine (2019), 2 descendants of its own
- K230386: SpassageQ (2023), 1 descendant of its own
- K240558: Navoycds (2024), 0 descendants of its own

## Indications for use
The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient’s monitored vital signs change from those measured at baseline, which has been derived from measurements previously obtained during routine activities of daily living. The MCI is based on an integrated computation evaluating changes in the parameters and their relationships to each other. The PPA Engine is an adjunct to and is not intended to replace vital signs monitoring. The MCI is intended for daily intermittent, retrospective review by a qualified practitioner. The PPA Engine is intended to provide additional information for use during routine patient monitoring. The MCI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

Source page: https://510kreport.com/device/K142512
Methodology: https://510kreport.com/methodology