(60 days)
The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.
The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.
The provided text describes the MiniGuard™ Arterial Safety Valve, outlining its intended use, technological characteristics, and performance data to support its substantial equivalence to a predicate device (RetroGuard Arterial Safety Valve, K922356). However, the document does NOT contain explicit acceptance criteria defined by specific numerical thresholds for each test, nor a detailed study that directly "proves" the device meets these criteria in the typical sense of a clinical trial or a statistically powered performance study against pre-defined metrics.
Instead, the document states: "Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance." This implies that internal specifications were met, but these specifications are not explicitly detailed for each test.
Therefore, the following information is extracted or inferred based on the provided text. Many fields cannot be directly answered due to the nature of the available document, which is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Inferred as 'met established specifications') |
|---|---|
| Biocompatibility: | Met established specifications for: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity and Hemocompatibility. |
| Visual Inspection: | Met established specifications. |
| Priming Volume: | Met established specifications. |
| Opening Pressure: | Met established specifications. |
| Minimum Flow Rate: | Met established specifications. |
| Maximum Flow Rate: | Met established specifications. |
| Retrograde Flow: | Met established specifications (i.e., successfully prevented retrograde flow as intended). |
| Pressure Drop: | Met established specifications. |
| Continuous Flow: | Met established specifications. |
| Leak Test: | Met established specifications. |
| High Pressure Leak Test: | Met established specifications. |
| Mechanical Hemolysis: | Met established specifications. |
Note: The document only states that the device "meets all established specifications necessary for consistent performance." It does not provide the specific numerical values for these specifications (e.g., "Opening pressure
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.