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The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.

The provided text describes a 510(k) summary for the "Pump Tubing with X-Coating" and its substantial equivalence to an uncoated pump tubing. The performance evaluation presented is primarily a comparison with the predicate device, rather than a study establishing standalone performance against specific acceptance criteria.

Here's an analysis based on your request, highlighting what is provided and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that the performance of the Pump Tubing with X-Coating was evaluated against the uncoated pump tubing to demonstrate equivalence.

The "performance evaluations" section lists the types of tests conducted:

• Dimensional/Visual Analysis
• Leakage and Mechanical Integrity Testing
• Pull Force Testing
• 6-hour Circulation Testing
  • Flow Rate
  • Durability/Spallation
  • Thrombus Formation (Visual)
  • Effects Upon Cellular Components (Hemolysis)

The "Substantial Equivalence Comparison" and "Substantial Equivalence Summary" sections state:

• "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."
• "Any noted differences between the two devices do not raise new issues of safety and effectiveness."

Without specific numerical acceptance criteria or quantitative performance data, a direct table cannot be constructed from the provided text. The criteria are implied to be "no clinically significant differences" compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the performance evaluations (e.g., how many pump tubing samples were tested for durability, hemolysis, etc.). It also does not mention the data provenance beyond indicating that Terumo Cardiovascular Systems Corporation conducted the studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the submitted document. The performance evaluations described are physical and chemical tests (e.g., flow rate, durability, hemolysis, visual thrombus formation), not diagnostic or interpretative tasks requiring expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3.

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 is not applicable. The device is pump tubing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is pump tubing, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluations would be the results of the physical, chemical, and biological tests performed. For example:

• Dimensional/Visual Analysis: Measured dimensions and visual inspection standards.
• Leakage and Mechanical Integrity Testing: Pre-defined leakage rates or structural failure points.
• Pull Force Testing: Defined maximum or minimum pull force thresholds.
• 6-hour Circulation Testing:
  • Flow Rate: Measured flow rate compared to a control or specification.
  • Durability/Spallation: Visual inspection for material degradation, particle generation, or functional failure.
  • Thrombus Formation (Visual): Visual assessment for the presence and extent of thrombus formation against a defined scale or absence.
  • Effects Upon Cellular Components (Hemolysis): Lab measurements of hemolysis levels compared to established safety limits or predicate performance.

For the biocompatibility studies, the "ground truth" was established by adhering to ISO 10993 guidelines and conducting an in-vivo animal study, where the absence of adverse conditions reflected acceptable biocompatibility.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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