Analytic for Hemodynamic Instability (AHI) is an AI-enabled medical device from Fifth Eye Inc. that the U.S. FDA granted through De Novo DEN200022 on March 1, 2021. Its lead review panel is Cardiovascular and its primary product code is QNV (Adjunctive Hemodynamic Indicator With Decision Point).
See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.
Key facts
| Submission number | DEN200022 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Fifth Eye Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | QNV — Adjunctive Hemodynamic Indicator With Decision Point |
| Applicant (openFDA) | Fifth Eye, Inc. |
| Applicant location | Ann Arbor, MI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2220 |
| 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. Analytic for Hemodynamic Instability (AHI) went through this pathway (DEN200022).
openFDA lists it as a Class 2 device under 21 CFR 870.2220. Class II devices are moderate risk and are subject to general and special controls.
Product code QNV covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. Fifth Eye Inc. 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.