Acumen Hypotension Prediction Index (HPI) Feature Software is an AI-enabled medical device from Edwards Lifesciences LLC that the U.S. FDA granted through De Novo DEN160044 on March 16, 2018. Its lead review panel is Cardiovascular and its primary product code is QAQ (Adjunctive Predictive Cardiovascular Indicator).
See also FDA-cleared AI cardiovascular devices in 2018, all FDA AI clearances in 2018, top cardiovascular AI devices.
Key facts
| Submission number | DEN160044 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Edwards Lifesciences LLC |
| Lead review panel | Cardiovascular |
| Primary product code | QAQ — Adjunctive Predictive Cardiovascular Indicator |
| Applicant (openFDA) | Edwards Lifesciences, LLC |
| Applicant location | Irvine, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2210 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Acumen Hypotension Prediction Index (HPI) Feature Software went through this pathway (DEN160044).
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 QAQ covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 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.