Device |
adjunctive open loop fluid therapy recommender |
Definition |
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s 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. |
Physical State |
The device consists of software shipped on a patient monitor. It collects data from first- or third-party sensors attached to the patient. |
Technical Method |
The device analyzes data collected from indwelling catheters to estimate a patient’s response to fluid therapy. |
Target Area |
The device target area is systemic due to the broad factors affecting a patient’s estimated responsiveness to fluid therapy during surgical procedures. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QMS |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
510(k)
|
Regulation Number |
870.5600
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|