21 CFR 870.1150 — Software Device System For Estimation Of Cardiac Pressures

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1150

Identification

PCWP Analysis Software is a prescription-only device intended to noninvasively estimate pulmonary capillary wedge pressure (PCWP) and identify patients with a PCWP above or below 18mmHg, for patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and New York Heart Association (NYHA) Functional Class II, III, IV symptoms. The device uses software algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate cardiac pressure. It is intended for adjunctive use by qualified healthcare professionals in conjunction with other standard of care parameters and is not intended to independently direct therapy or estimate systemic, vascular blood pressure.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II, which provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes