| Device |
adjunctive predictive cardiovascular indicator |
| Regulation Description |
Adjunctive predictive cardiovascular indicator. |
| 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. |
| 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 combines data collected from indwelling catheters to produce a single value that estimates the likelihood of a future adverse cardiovascular event. |
| Target Area |
The device target area is systemic due to the broad effects of hypotension during surgical procedures. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QAQ |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2210
|
|---|
| 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 |
Not Third Party Eligible |
