FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Cardiox Flow Detection System Model 99 provides a fluorescent ICG indicator dye dilution curve for cardiac output in patients with known or suspected circulatory pathway abnormalities. The system is not designed to produce a definitive interpretation or exhaustive evaluation of a patient's circulatory pathway. Rather, it is intended to be used as a support tool in conjunction with other clinical and diagnostic findings. This device is only intended for use on patients that weigh more than 10kg.

Device Description

The Cardiox Flow Detection System (FDS) Model 99 utilizes near infra-red (NIR) spectrophotometry to transcutaneously detect the presence and relative concentration of indocyanine green dye (ICG) in blood vessels located at the scaphoid fossa of the ear. The indicator dye, ICG, is injected into a peripheral antecubital vein of the patient while the patient optionally blows into the ValsalvaSure™ mouthpiece. The exhalation by the patient into the mouthpiece (i.e., performing a Valsalva maneuver) is available to provide conditions that may expose abnormal blood flow. The ValsalvaSure maneuver creates a pressure differential resulting in a right-to-left flow of blood between the atria, which results in a right-to-left-shunt (RLS) through any existing Atrial Septal Defect (ASD) and/or patent foramen ovale (PFO). The RLS allows blood to flow directly from the right atrium of the left atrium of the heart without passing through the lungs. The optical sensors in the Cardiox Earpads measure the relative concentration (i.e., fluorescence signal level) of ICG in the bloodstream as a function of time. Once captured by the photodiodes, the measured fluorescence signal is transmitted to the FDS Monitor. In a subject with a normal circulatory pathway, the ICG is injected into an antecubital vein, travels through the heart and lungs then into the arterial vasculature, and is detected at the scaphoid fossa of the ear. The magnitude of the ICG curve peak amplitude is measured and displayed by the Cardiox FDS monitor, and is referred to as the Major Curve Peak Amplitude. in a subject with an abnormality in the circulatory pathway, such as a RLS, some of the ICG dye arriving in the right atrium follows a shorter pathway between the right atrium and left atrium, instead of traveling through the anatomically longer pathway through the lungs. This fraction of ICG dye that passes through an anatomical abnormality arrives at the scaphoid fossa of the ear in advance of the main bolus of ICG dye that follows the normal circulatory pathway through the lungs. The magnitude of the ICG curve peak amplitude associated with the earlier arrival of dye is measured and displayed by the Cardiox FDS monitor, and is referred to as the Minor Curve Peak Amplitude. The report generated by the Cardiox FDS Model 99 identifies the Major Curve and Minor Curve Peak Amplitudes.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Cardiox™ Flow Detection System™, Model 99. The document primarily focuses on the 510(k) summary, device description, comparison to predicate devices, and a list of standards the device conforms to. It lacks concrete performance data and study design details typically found in a clinical or performance validation study report.

Therefore, I cannot populate the requested table and answer many of the questions regarding the study that proves the device meets acceptance criteria.

However, based on the provided information, I can state the following:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision for measuring minor/major peak amplitudes) are provided in the document. The document states that the new device and predicate devices have "similar technological characteristics and principles of operation" and that "[the] differences do not present any new issues of safety or effectiveness because the difference in the two technology's methods to measure the ICG dye concentration is not significant and does not have an impact on the performance of either device for its intended use." This suggests a reliance on equivalence to predicate devices rather than specific performance targets for the new device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)