Product Classification

• Device: atrial fibrillation risk prediction machine learning-based notification software
• Definition: Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up.
• Physical State: Consists of one or more non-invasive physiological inputs, a machine learning based for disease detection or classification, and an output on the presence, absence, or likelihood of a future occurrence of atrial fibrillation.
• Technical Method: non-invasive physiological measurement(s)
• Target Area: Cardiovascular
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: SBQ
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.2380
• 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