| Device |
medium-term 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 within a defined medium-term period. 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 for use on a computing device. It collects data from first- or third-party sensors attached to the patient. |
| Technical Method |
The device combines patient data collected from patient monitors and/or electronic health records to produce a single value that estimates the likelihood of a future adverse cardiovascular event or condition. |
| Target Area |
Human body |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QNL |
|---|
| 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 |
