| Device |
coronary artery disease risk indicator from acoustic heart signals |
| Regulation Description |
Coronary artery disease risk indicator using acoustic heart signals. |
| Definition |
A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis. |
| Physical State |
Microphone in the sensor to record acoustic heart sounds, interface to enter clinical features and the clinician views the algorithm output |
| Technical Method |
Acoustic and clinical features recorded and inputted into an algorithm and outputs a CAD risk score |
| Target Area |
The chest area over the heart |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QMW |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1420
|
|---|
| 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 |
