(88 days)
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.
The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container. The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.
Here's an analysis of the provided text regarding the RMI Hemoconcentrator Tubing Set, structured to address your specific questions.
Note: The provided text primarily focuses on biocompatibility and basic functional performance testing. It does not contain information related to AI/ML device performance, ground truth establishment, expert consensus, or multi-reader multi-case studies. Therefore, many of your requested points will be marked as "Not Applicable" or "Not Provided in Text."
Acceptance Criteria and Device Performance for RMI Hemoconcentrator Tubing Set
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not cytotoxic | The test article is not cytotoxic (MEM Elution Test). |
| Not a significant sensitizer | Upon rechallenge, none of the test group or negative control animals exhibited scores higher than 1 (response of 1 is not considered significant sensitization) (Guinea Pig Maximization). | |
| Meets USP Intracutaneous Test requirements | The test article met the requirements of the USP Intracutaneous Test. | |
| Meets USP Systemic Injection Test requirements | The test article met the requirements of the USP Systemic Injection Test. | |
| Hemolysis ≤ Acceptable Limit (Implicitly 0% or very low) | The test article had 0.00% Hemolysis. | |
| Functional / Performance Testing | ||
| Flow vs. Pressure (Blood Flow) | Deliver flows exceeding 1000 ml/min with line pressure |
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).