FDA product code SIF: Software Device System For Estimation Of Cardiac Pressures

SIF is the FDA product code for software device system for estimation of cardiac pressures. It is a Class II device, regulated under 21 CFR 870.1150 and reviewed by the Cardiovascular panel. Devices under SIF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.

Classification

Recalls for SIF devices

openFDA lists no recalls for product code SIF.

Frequently asked questions

What is FDA product code SIF?

SIF is the FDA product code for software device system for estimation of cardiac pressures. It is a Class II device, regulated under 21 CFR 870.1150 and reviewed by the Cardiovascular panel.

What device class is SIF?

Class II, regulation 21 CFR 870.1150. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SIF
• Run a recall and safety report across every SIF manufacturer
• Watch product code SIF for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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