| Device |
adjunctive open loop fluid therapy recommender |
| Regulation Description |
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 |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
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
|
