Cardiovascular · 510(k) · 2023
Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC. Cleared by FDA on 26 July 2023 under submission K231038, product code QNL (medium-term adjunctive predictive cardiovascular indicator). What FDA's record says, in FDA's words.
Device record · K231038
- Device. Global Hypoperfusion Index (GHI) AlgorithmDEVICE
- Company. Edwards Lifesciences, LLCCOMPANY
- Decision. 26 July 2023, 510(k), substantially equivalent (traditional review); received 12 April 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QNL, Medium-Term Adjunctive Predictive Cardiovascular IndicatorCODE
- Regulation. 21 CFR 870.2210, Class IIREG
- Source. FDA database entry · decision document (7 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.
related to the patient’s predicted future risk for clinical deterioration. Device Description: The Global Hypoperfusion Index (GHI) parameter provides the clinician with physiological insight into a patient’s likelihood of a global hypoperfusion event on average 10- 15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or non- surgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter. Indications for Use: Global Hypoperfusion Index (GHI) Software Feature The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. T he GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. T he GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
The product code's definition, from FDA's classification record. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNL. 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 QNL, in Cardiovascular, from Edwards Lifesciences, LLC, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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