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The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

The IBC FloGard is a single-use, disposable, check valve intended for use for the prevention of retrograde flow in the arterial line when used with centrifugal pumps during open-heart surgery. The device is designed for use in the main arterial line when centrifugal pumps are used. The fully assembled IBC FloGard Valve is geometrically similar to the Quest RetroGuard 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, specific dimensions of the component parts and the type of check valve used. 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 Quest RetroGuard is made of clear ABS. The polycarbonate is clearer, has higher impact resistance, greater tensile and compression strength and superior chemical resistance. Secondly, the straight duck bill check valve in the predicate device, Quest RetroGuard, required an oversized body to accommodate clinical flow rates without a substantial resistance to flow. The bi-leaflet design of the check valve in the IBC FloGard valve substantially reduces the size of the flow through housing without increasing resistance to flow. This geometry substantially lowered prime volume and hemolysis.

This looks like a submission for a medical device (IBC FloGard) seeking 510(k) clearance, which means the manufacturer is trying to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device (Quest RetroGuard). The analysis primarily involves comparing performance characteristics rather than establishing de novo clinical efficacy through large-scale trials.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly substantial equivalence to the predicate device, Quest RetroGuard, particularly in key performance metrics relevant to its intended use in cardiopulmonary bypass. The document provides comparison results directly.

Note: For many metrics, the specific numerical values for current and predicate devices are not provided in the executive summary, only qualitative comparisons. The implicit acceptance criterion is that the IBC FloGard performs as well as or better than the Quest RetroGuard in these critical areas, demonstrating substantial equivalence.

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

• Sample Size:
  • The study involved comparing "the IBC FloGard (sterile, 6 month aged, environmentally conditioned)" against the "Quest RetroGuard." It's not explicitly stated how many units of each device were tested for each metric (e.g., how many FloGard valves for pressure drop, how many RetroGuard valves for hemolysis). It refers to "the IBC FloGard Valve" and "the Quest RetroGuard valve" implying a representative sample, but specific numbers are absent.
• Data Provenance: The study was conducted by IBC, the manufacturer, as part of their 510(k) submission. This is retrospective in the context of device development (i.e., tests were run on finished devices to support the submission). The data is generated internally by the company for regulatory purposes. Country of origin for data generation is not specified but assumed to be the US given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This type of device clearance (510(k) for a physical medical device like a check valve) primarily relies on engineering and laboratory performance testing, not expert-established "ground truth" on diagnostic images or clinical outcomes.
• Therefore, no experts were explicitly described as establishing ground truth in the way a radiologist might for an AI diagnostic algorithm. The "ground truth" for this device's performance is derived from standardized laboratory measurements (e.g., flow rates, pressure, hemolysis assays). The "experts" involved would be the biomedical engineers and lab technicians conducting the tests, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 reconciliation are typically used for establishing ground truth in clinical data (e.g., imaging studies where multiple readers interpret cases to reach a consensus).
• For this device, the "adjudication" is inherent in the reproducibility and standardization of the laboratory tests and comparison against established physical principles and the predicate device's measured performance.

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

• No. An MRMC study is not relevant for this type of device (a mechanical check valve). MRMC studies evaluate the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This device is a component in a cardiopulmonary bypass circuit, not a diagnostic tool requiring human interpretation.

6. If a Standalone Performance Study was done

• Yes, a standalone performance characterization was done for the IBC FloGard, and importantly, it was conducted side-by-side with the predicate device (Quest RetroGuard). This is crucial for demonstrating substantial equivalence.
• The description details various tests:
  • Pressure drop measured at 4 L.P.M.
  • Hemolysis measured at 7 L.P.M. for 6 hours.
  • Reverse-flow measured at 100 mm Hg back-pressure.
  • Pressure required to close the valves.
  • Biocompatibility, bioburden, and sterilization.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established through:
  • Direct physical measurements and laboratory assays: Pressure, flow rate, hemolysis, reverse flow, prime volume measurements.
  • Compliance with recognized standards: Biocompatibility tested against "tripartite biocompatible ISO standards and the FDA modified matrix of 1995."
  • Comparison to a legally marketed predicate device: The performance metrics are held against the measured performance of the Quest RetroGuard.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical component, not an AI/ML algorithm that requires a "training set." The engineering design and material selection process are not "trained" on data in the same way an algorithm is.

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

• Not applicable, as there is no training set for a mechanical device. The design and validation are based on engineering principles, material science, and performance testing against specified requirements and predicate device characteristics.

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