| Device |
adjunctive cardiovascular status indicator |
| Regulation Description |
Adjunctive cardiovascular status indicator. |
| Definition |
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). 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 |
Software/Firmware |
| Technical Method |
The physiological status indicator matches subject waveforms to known waveforms in an attempt to provide a comprehensive measure of all the changes that are in the PPG waveform. The major assumption is that central blood volume, or more specifically individual tolerance to reduced central blood volume, is the major determinant of the PPG waveform shape. This entry applies to the De Novo for which this procode was created. Future devices under this procode could potentially use different technical methods which still fit the general "intended use" of this classification. |
| Target Area |
Various |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PPW |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2200
|
|---|
| 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 |
