DEN190029 is an FDA 510(k) submission for the Acumen Assisted Fluid Management (AFM) Software Feature. This device is classified as a Adjunctive Open Loop Fluid Therapy Recommender (Class II - Special Controls, product code QMS).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5600. The Adjunctive Open Loop Fluid Therapy Recommender Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict A Patients Estimated Response To Fluid Therapy. The 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 | DEN190029 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 03, 2019 |
| Decision Date | November 13, 2020 |
| Days to Decision | 529 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QMS - Adjunctive Open Loop Fluid Therapy Recommender |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5600 |
| Definition | The Adjunctive Open Loop Fluid Therapy Recommender Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict A Patients Estimated Response To Fluid Therapy. The Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |