DEN160044 is an FDA 510(k) submission for the Acumen Hypotension Prediction Index (HPI) Feature Software. This device is classified as a Adjunctive Predictive Cardiovascular Indicator (Class II - Special Controls, product code QAQ).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Not Cleared (DENG) decision on March 16, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2210. 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. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | DEN160044 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 26, 2016 |
| Decision Date | March 16, 2018 |
| Days to Decision | 536 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | QAQ — Adjunctive Predictive Cardiovascular Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2210 |
| Definition | 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. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |