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The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).

The IBC VRV Valve is a single use, disposable, vacuum and pressure relief, check valve that is intended for use during open-heart surgery for left ventricular venting. It is sometimes commonly referred to as a suction control valve for left ventricular venting. The device is designed for use in a suction line and must be used in accordance with the operating parameters of that blood recovery line. The fully assembled IBC VRV Valve is geometrically similar and clinically the same to the Omni Model RLV-2100"B" VRV valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical.

The differences between the IBC VRV and the predicate device are found in the material selection and specific dimensions of the component parts neither of which effects safety or effectiveness of the product. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Omni RLV-2100"B" is made of ABS. The polycarbonate is clear, has higher impact resistance, greater tensile and compression strength and superior chemical. Upon review of the predicate device, we found the inability to see the interior of the device made it difficult for the user to identify the vacuum relief point. The use of polycarbonate eliminated that problem. Secondly, the straight duck bill check valve in the predicate device represents a substantial resistance to flow which contributes significantly to hemolysis. The unique curved design of the duckbill check valve in the IBC VRV substantially reduces flow resistance and hemolysis.

The provided text is a 510(k) submission for the IBC VRV Valve. The submission aims to demonstrate substantial equivalence to a predicate device, the Omni Model RLV-2100"B" VRV valve. The "acceptance criteria" and "study" described herein are focused on demonstrating this substantial equivalence through a side-by-side comparison.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria are based on the functional equivalence of the IBC VRV to its predicate device, the Omni RLV-2100"B". The study aims to show that the IBC VRV performs as well as, or better than, the predicate device across several key performance parameters. While explicit numerical "acceptance criteria" are not given in the document (e.g., "vac_relief_rate must be > X"), the implication is that the IBC VRV's performance should be comparable to the predicate device.

Study Details

2. Sample Size for Test Set and Data Provenance:

• Sample Size:
  • The text indicates the IBC VRV (sterile, 6 month aged, environmentally conditioned) was subjected to dynamic tests in a "side by side comparison" with the Omni RLV-2100"B".
  • For hemolysis, the study used "fresh bovine blood at 45% hematocrit" for a simulated clinical circuit.
  • Specific quantities of devices tested are not explicitly stated. It refers to "the IBC VRV" and "the Omni RLV-2100"B"" in the singular sense when describing the tests, implying at least one of each, but typically a few units would be tested.
• Data Provenance: The tests are described as dynamic tests and a simulated clinical circuit performed in a laboratory setting. There is no indication of human subject data. The use of "fresh bovine blood" suggests a laboratory study setting rather than real clinical data.

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

• Not applicable. This device is a mechanical valve, and the "ground truth" is established by physical measurement of its performance parameters (vacuum relief rate, pressure drop, hemolysis, vent function). This is not equivalent to establishing ground truth for diagnostic imaging or clinical decisions where expert consensus is needed.

4. Adjudication Method for the Test Set:

• Not applicable. As the "ground truth" is based on physical measurements, an adjudication method for expert review is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a diagnostic device or a system relying on human interpretation. Therefore, an MRMC study is not relevant or described.
• The text does state that a "perfusionist substituting an IBC VRV for an Omni RLV-2100"B" in his or her perfusion circuit will be unable to distinguish between the two valves functionally." This is a statement about perceived equivalence in function rather than a formal MRMC study evaluating human performance with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Yes, effectively. The dynamic tests performed on the IBC VRV and the predicate device are "standalone" in the sense that they measure the inherent mechanical performance of the devices themselves, without direct human intervention as part of the measured performance (though humans operate the test equipment). This is an "algorithm only" equivalent for a mechanical device.

7. The Type of Ground Truth Used:

• The ground truth is established through physical measurements and engineering tests of the device's performance parameters (vacuum relief rate, pressure drop, hemolysis rate, and vent functionality) in a simulated environment. The predicate device's performance serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This is a mechanical medical device, not a machine learning or AI-driven system. Therefore, there is no "training set" in the context of AI. The device's design is based on engineering principles and materials science.

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

• Not applicable. As there is no training set for an AI model, this question does not apply.

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