(172 days)
The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The purpose of this report is to demonstrate the equivalence of the IBC Quick Cell component, as a substitute for the CDI Kwik Cell component.
The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IBC Quick Cell component is identical to the final geometry of the 3M Kwik Cell component, and both are fabricated from the same plastic materials. Performance of the IBC Quick Cell component within the CDI Model 400 Blood Gas Monitoring System is identical to the CDI Kwik Cell component. The materials were evaluated for toxicity and sterilization compatability requirements as well as for function.
The CDI Model 400 Blood Gas Monitoring System er ploys three photochemical sensors to measure pO3, pCO2 and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature. The Electronics also contain calculation programs which use the measured parameters to determine O2 Saturation (Venous side only) and Base Excess/[HCO3] (Arterial side only). To complete the necessary calculations for these approximations, the Hemoglobin content is also required. This value is internally set at a Hematocrit of 25%. This value is corrected by the user during the initial and any subsequent on line recalibrations.
The functional properties of the Quick Cells are determined by the final assembly geometry and the materials employed in construction, especially the membrane material. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membrane was sourced from the same supplier used by 3M.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the IBC Quick Cell Component:
IBC Quick Cell Component Acceptance Criteria and Study Analysis
The document details a study conducted to demonstrate the equivalence of the IBC Quick Cell component to the CDI Kwik Cell component, for use with the CDI Model 400 Blood Gas Monitoring System.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria for functional performance (e.g., pH difference
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).