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 |