(279 days)
As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications. The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.
"IQ™ System" Cardiac Output Monitor
The provided document is a 510(k) clearance letter from the FDA for the "IQ™ System" Cardiac Output Monitor. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study information usually found in a submission or a summary of safety and effectiveness data.
Therefore, I cannot provide the requested information based solely on the provided text. The document is essentially a regulatory approval letter, not a technical report or study summary.
To answer your request thoroughly, I would need to access the full 510(k) submission (K981720) itself, or a summary of safety and effectiveness that would typically accompany such a submission. This document only confirms the device's clearance and its intended use.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.