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The COBE® HVR® 2200 Hardshell Venous Reservoir is intended to be used in surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

The COBE® HVR® 2200 Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways. It is designed for single use only, and is not to be restenlized by the user. The device is an open, hardshell venous blood reservoir intended to be used during cardical procedures requiring extracorporeal support for periods of up to six hours. The COBE HVR 2200 is a smaller version of the COBE® HVR® 4000 Hardshell Venous Reservoir (K971669, K984456). The COBE® HVR® 4000 Hardshell Venous Reservoir has a maximum volume of 4000 ml, while the COBE® HVR® 2200 Hardshell Venous Reservoir has a maximum volume of 2200 ml. The smaller volume of the reservoir makes the COBE HVR 2200 more suited for smaller adult and pediatric patients, while the COBE HVR 4000 is for adult patients.

The COBE HVR 2200 is used during cardiopulmonary bypass surgery to receive and store the patient's venous blood and to act as blood volume buffer, as well as to receive raw cardiotomy suction blood and filter it prior to returning it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy suction blood by the defoamer. The major components of the device are the bucket, the porting, 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 porting provides blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from incoming venous and cardiotomy suction blood, and the filter removes particles from the cardiotomy suction return blood.

Here's an analysis of the provided text regarding the COBE HVR 2200 Hardshell Venous Reservoir, focusing on acceptance criteria and supporting studies.

Based on the provided text, the device is a Class II/III medical device, and its approval process appears to be a 510(k) premarket notification. For 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application. Therefore, the information provided focuses on comparative testing against a predicate device.

Description of Acceptance Criteria and Proving Device Meets Criteria

The document states that biocompatibility and performance tests were conducted to demonstrate substantial equivalence to the predicate device (Medtronic Minimax Filtered Hardshell Venous Reservoir). The "acceptance criteria" are implicitly met by demonstrating performance comparable to the predicate device in the listed tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed in terms of pass/fail values but are instead based on demonstrating similar performance to the predicate device. The reported performance is a general statement affirming substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the performance tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be non-clinical (bench testing) as is common for 510(k) submissions for devices of this type.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the document. The testing described is performance testing of a physical device, not related to expert interpretation of data or images.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document as it refers to expert consensus, which is not relevant for this type of device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is relevant for diagnostic devices that involve human interpretation of results, such as imaging software, which is not the case for this medical device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This concept is not applicable to the COBE HVR® 2200 Hardshell Venous Reservoir. This device is a physical component used in a medical procedure, not an algorithm or a diagnostic tool that would operate in a "standalone" or "human-in-the-loop" fashion. Its performance is measured directly through physical and biological testing.

7. Type of Ground Truth Used

The "ground truth" for the performance tests would be established through laboratory measurements and established industry standards for evaluating the performance characteristics listed (e.g., defoaming capability, filtration efficiency, blood trauma). The performance of the predicate device would also serve as a reference for comparison.

8. Sample Size for the Training Set

There is no mention of a "training set" in this context. Training sets are relevant for machine learning algorithms. This device is a physical medical device, not an AI or software product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this medical device.

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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.

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.

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