510(k) · Cardiovascular

Global Hypoperfusion Index (GHI) Algorithm

by Edwards Lifesciences, LLC

Global Hypoperfusion Index (GHI) Algorithm is an AI-enabled medical device from Edwards Lifesciences, LLC that the U.S. FDA cleared through 510(k) K231038 on July 26, 2023. Its lead review panel is Cardiovascular and its primary product code is QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator).

See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.

Key facts

Submission numberK231038
Pathway510(k)
Date of final decision
Company (FDA list)Edwards Lifesciences, LLC
Lead review panelCardiovascular
Primary product codeQNL — Medium-Term Adjunctive Predictive Cardiovascular Indicator
Applicant (openFDA)Edwards Lifesciences, LLC
Applicant locationIrvine, CA, US
Device classClass 2
Regulation number21 CFR 870.2210
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Global Hypoperfusion Index (GHI) Algorithm went through this pathway (K231038).

openFDA lists it as a Class 2 device under 21 CFR 870.2210. Class II devices are moderate risk and are subject to general and special controls.

Product code QNL covers 5 devices on the FDA AI list. By decision date, this device is #2 of 5 under that code. Edwards Lifesciences, LLC has 3 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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