(27 days)
The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.
The COBE® HVR" 4000 Fittered Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is an open venous blood reservoir with integral cardiotomy filter.
Here's an analysis of the provided text regarding the COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K971669) rather than establishing novel safety and effectiveness acceptance criteria. Therefore, the "acceptance criteria" are implied to be that the modified device performs similarly or equivalently to the predicate device across various in-vitro tests. The "reported device performance" refers to the results of these comparative tests.
| Acceptance Criteria (Implied: Equivalent to Predicate Device K971669) | Reported Device Performance (Implied: Achieved Equivalence) |
|---|---|
| Venous Blood Flow Performance | Demonstrated equivalence to predicate device |
| Defoaming Capacity | Demonstrated equivalence to predicate device |
| Filtration Efficiency | Demonstrated equivalence to predicate device |
| Operating Volume (Range: Minimum & Maximum) | Demonstrated equivalence to predicate device |
| Breakthrough Volume | Demonstrated equivalence to predicate device |
| Unrecoverable Volume | Demonstrated equivalence to predicate device |
| Filter Loading Capacity | Demonstrated equivalence to predicate device |
| Blood Trauma Effects | Demonstrated equivalence to predicate device |
Note: The document explicitly states, "In-vitro tests were performed to demonstrate that the modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR® 4000 Filtered Hardshell Venous Reservoir (K971669)." This indicates that the goal of the study was to show similar performance, rather than meet specific numerical thresholds that aren't provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the in-vitro tests. It only lists the types of tests performed.
- Data Provenance: The data is described as "In-vitro tests." This indicates the data was generated in a laboratory setting, likely in the US (where COBE Cardiovascular, Inc. is located). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. The "ground truth" for this type of device modification (material change in a component) is established through technical performance testing against a known predicate device, not through expert consensus or interpretation of medical images/outcomes.
4. Adjudication Method for the Test Set
This section is not applicable. Since the testing involved in-vitro performance measurements, there's no need for an adjudication method as would be used in studies involving human interpretation or clinical outcomes.
5. 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
This section is not applicable. This submission is for a medical device (a venous reservoir used in cardiopulmonary bypass), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and concepts of human reader improvement with AI are irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. Again, this involves a medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is the established performance characteristics of the predicate device (COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, K971669). The in-vitro tests aimed to demonstrate that the modified device's performance aligns with, or is equivalent to, these known characteristics.
8. The Sample Size for the Training Set
This section is not applicable. This is a device modification submission, not a machine learning model development. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.