Tempus ECG-MR IFU

Unique Device Identifier (UDI): (01)00860011843641(10)210
Device Software Version: 2.1.0

For additional information on device specifications, model training, and clinical performance testing, please refer to the Tempus ECG-MR Instructions for Use.

Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients:

• 65 years of age or older
• At risk of cardiovascular disease. Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease, hypertension, obesity, or diabetes; or other signs or symptoms of heart disease, such as dyspnea, chest pain, or lower extremity edema.
• Without prior mitral valve intervention
• Without prior diagnosis of moderate or severe mitral regurgitation

Tempus ECG-MR only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-MR is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.

• Tempus ECG-MR has not been evaluated in and should not be used for patients younger than 65 years of age.
• Tempus ECG-MR is not intended to replace other diagnostic tests.
• Results do not represent a diagnosis of mitral regurgitation. 
• Results do not rule-out mitral regurgitation. 
• Tempus ECG-MR should not be used on ECG recordings with paced rhythms.
• Tempus ECG-MR should not be used for serial patient monitoring. Serial testing for the same patient has not been validated.
• Tempus ECG-MR should not be used to initiate any therapy or treatment for MR. 
• Tempus ECG-MR should not be used for repeated testing of the same patient within a 12 month period.

[RESULT: MITRAL REGURGITATION DETECTED]

Interpretation: This result indicates the device detected signs associated with moderate or severe mitral regurgitation in the analyzed ECG tracing. This result does not represent a diagnosis of mitral regurgitation.
Next Steps: In combination with other clinical information, consider further diagnostic evaluation to determine if mitral regurgitation is present. Do not initiate any treatments based solely on this result.

[RESULT: MITRAL REGURGITATION NOT DETECTED]

Interpretation: This result indicates the device did not detect signs associated with moderate or severe mitral regurgitation in the analyzed ECG tracing. This result does not rule out current or future mitral regurgitation.
Next Steps: Continue to evaluate for mitral regurgitation in accordance with current medical practice standards.

[RESULT: UNCLASSIFIABLE]

Interpretation: This result indicates a technical error. The provided ECG tracing could not be analyzed due to characteristics of the ECG tracing and/or associated patient data.
Next Steps: Submit a new ECG that meets input criteria for ECG-MR evaluation. If a new ECG cannot be provided or input criteria cannot be met, continue to evaluate for mitral regurgitation in accordance with current medical practice standards.