(120 days)
The COBE® VVR 4000" Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.
The COBE® VVR 4000" Filtered Hardshell Venous Reservoir, a sealed hardshell venous reservoir with defoamer and integral cardiotomy filter, is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. It is designed for collection and return of postoperative chest drainage, and for storage and filtration of blood during adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.
The maximum capacity of the COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is approximately 4000 ml. The device operates at venous blood flow rates up to 8 liters/minute, cardiotomy flow rates up to 4 liters/minute, or at a combined maximum flow rate of 8 liters/minute.
During cardiopulmonary bypass, the device receives the patient's venous blood (under vacuum assisted or non-vacuum assisted venous return conditions) and also receives cardiotomy suction blood and filters it prior to returning it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy blood by the defoamer.
Following cardiopulmonary bypass, the device may be converted for use in postoperative chest drainage. Shed blood which has been stored in the reservoir less than six hours may be autotransfused for blood volume replacement.
The major components of the reservoir are the bucket, the defoamer, and the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The ports provide blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from the incoming venous and cardiotomy suction blood, and the filter removes particles from cardiotomy suction blood.
The provided text describes a 510(k) premarket notification for a medical device and its substantial equivalence to predicate devices, rather than a study proving the device meets explicit acceptance criteria through quantitative performance metrics. As such, direct answers to many of the requested points (e.g., sample sizes, expert qualifications, adjudicated ground truth, MRMC studies, effect sizes) cannot be extracted from this documentation.
However, I can infer the "acceptance criteria" based on the tests performed for substantial equivalence. The "study" in this context refers to the in-vitro testing comparing the COBE® VVR 4000™ to its predicate devices.
Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence Claim)
The "acceptance criteria" are not explicitly stated with numerical thresholds. Instead, the device is deemed to meet acceptance criteria by demonstrating "substantial equivalence" to predicate devices through in-vitro tests and biocompatibility testing. The reported "performance" is that it performs comparably or acceptably to the established predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility (equivalent to predicate devices) | Passed biocompatibility tests |
| Filtration Efficiency (equivalent to predicate devices) | Demonstrated acceptable filtration efficiency |
| Minimum Operating Volume (equivalent to predicate devices) | Demonstrated acceptable minimum operating volume |
| Pressure Relief Valve Operation (equivalent to predicate devices) | Demonstrated acceptable pressure relief valve operation |
| Reservoir Implosion Resistance (equivalent to predicate devices) | Demonstrated acceptable reservoir implosion resistance |
| Blood Cell Damage (equivalent to predicate devices) | Demonstrated acceptable levels of blood cell damage |
Detailed Information based on the provided text:
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A table of acceptance criteria and the reported device performance:
See the table above. The "acceptance criteria" are implied by the requirement to demonstrate substantial equivalence to the predicate devices across these performance categories. The "reported device performance" is that it met this equivalence. -
Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for the in-vitro tests (e.g., how many units were tested for filtration efficiency). The data provenance is implied to be from COBE Cardiovascular, Inc.'s internal testing, as part of their 510(k) submission. The data is retrospective in the sense that it was generated for the submission, not a prospective clinical trial. There is no mention of country of origin of the data beyond the manufacturer's location in the USA. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. For device performance testing, "ground truth" is typically established through standardized measurement methods and comparison against engineering specifications or predicate device performance, not by expert consensus in the way a diagnostic algorithm might be evaluated. -
Adjudication method for the test set:
Not applicable in the context of in-vitro device performance testing as described. Adjudication is typically for resolving disagreements in expert interpretations, which is not the nature of these tests. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC study was not done. This device is a hardware component (venous reservoir), not an AI-assisted diagnostic or therapeutic tool. Therefore, human reader improvement with AI assistance is not relevant to this device's evaluation. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the testing described ("in-vitro tests") can be considered "standalone" in the sense that it evaluates the device's technical performance characteristics independently. However, the term "algorithm" is not applicable here as it's a physical medical device, not a software algorithm. -
The type of ground truth used:
The ground truth for the in-vitro tests would have been established by engineering standards, validated measurement techniques, and potentially the established performance characteristics of the predicate devices. For example, "filtration efficiency" would have a quantifiable ground truth based on particle count, and "blood cell damage" would have a ground truth based on established methods for measuring hemolysis or other cellular injury. -
The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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.