Tempus ECG-PH IFU

Unique Device Identifier (UDI): (01)00860011843627(10)300
Device Software Version: 3.0.0

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

Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients:

• 40 years of age or older
• with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema)
• who do not have a known history of PH

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

• Tempus ECG-PH has not been evaluated in and should not be used for patients younger than 40 years of age.
• Tempus ECG-PH should not be used on ECG recordings with paced rhythms.
• Tempus ECG-PH is not intended to replace other diagnostic tests.
• Results do not represent a diagnosis of pulmonary hypertension.
• Results do not rule-out pulmonary hypertension.
• Tempus ECG-PH should not be used to initiate any therapy or treatment for pulmonary hypertension.
• Invasive follow-up testing such as right heart catheterization (RHC) should not be performed based solely on Tempus ECG-PH results.
• Tempus ECG-PH should not be used for serial patient monitoring. Serial testing for the same patient has not been validated.
• Tempus ECG-PH should not be used for repeated testing of the same patient within a 12 month period.

[RESULT: ELEVATED PH RISK DETECTED]

Interpretation: This result indicates the device detected signs associated with having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH), in the analyzed ECG tracing. This result does not represent a diagnosis of pulmonary hypertension.
Next Steps: In combination with other clinical information, consider further diagnostic evaluation to determine if pulmonary hypertension is present. Invasive follow-up testing such as right heart catheterization (RHC) should not be performed based solely on this result. Do not initiate any treatments based solely on this result.

[RESULT: ELEVATED PH RISK NOT DETECTED]

Interpretation: This result indicates the device did not detect signs associated with having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH), in the analyzed ECG tracing. This result does not rule out current or future pulmonary hypertension.
Next Steps: Continue to evaluate for pulmonary hypertension 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-PH evaluation. If a new ECG cannot be provided or input criteria cannot be met, continue to evaluate patient for pulmonary hypertension in accordance with current medical practice standards.