(41 days)
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Medtronic uncoated Tubing and Connector Components are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect the primary devices of the bypass circuit. The lumen of the uncoated Tubing and Connector Components consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The uncoated Tubing Components are comprised of polyvinyl chloride (PVC) and the uncoated Connector Components are comprised of polycarbonate and Plastisol. The uncoated Connectors are provided in Y-type, straight, and reducer configurations with ½ inch to ½ inch connection sites.
This document is a 510(k) summary for the Medtronic Uncoated Tubing and Connector Components. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a specific level of performance through extensive clinical studies like those typically associated with AI/ML devices or novel therapies.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth is generally not applicable in the context of this 510(k) submission for a non-active medical device like tubing and connectors. The approval is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through performance and biological testing.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
The document states: "Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria". However, the specific quantitative acceptance criteria and the detailed reported performance values for each test are not provided in this 510(k) summary. The summary only lists the types of performance tests conducted.
| Test Type | Acceptance Criteria (Not Detailed) | Reported Performance (Not Detailed) |
|---|---|---|
| Shelf life | Met pre-determined criteria | Met pre-determined criteria |
| Pressure Integrity | Met pre-determined criteria | Met pre-determined criteria |
| Kink Resistance | Met pre-determined criteria | Met pre-determined criteria |
| Pressure Decay | Met pre-determined criteria | Met pre-determined criteria |
| Spallation | Met pre-determined criteria | Met pre-determined criteria |
| Pull Force | Met pre-determined criteria | Met pre-determined criteria |
| Method of sterilization and sterility assurance level | Met pre-determined criteria | Met pre-determined criteria |
| Blood Trauma | Met pre-determined criteria | Met pre-determined criteria |
| Biocompatibility | Met pre-determined criteria (EN ISO 10993-1:2009) | Met pre-determined criteria |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for any of the performance or biological tests. All testing is implied to be prospective and conducted by Medtronic, likely in a lab setting, given the nature of the device (tubing and connectors). There is no mention of country of origin for data as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is an inert medical component. "Ground truth" in the context of clinical outcomes or expert consensus for AI/ML devices is not relevant here. Performance is evaluated against engineering specifications and biological safety standards.
4. Adjudication method for the test set
This is not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert opinions for a diagnostic task. Performance is measured against physical and chemical standards.
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. This device is not an AI-powered diagnostic tool, nor does it have human "readers" in the context of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
"Ground truth" for this type of device refers to objectively measurable physical, chemical, and biological properties. This includes:
- Engineering specifications: For properties like pressure integrity, kink resistance, pull force, and pressure decay.
- Material standards: For aspects like spallation.
- Sterilization standards: For sterility assurance level.
- Biocompatibility standards: Specifically EN ISO 10993-1:2009 for biological evaluation.
- Chemical analysis/testing: For blood trauma (e.g., hemolysis).
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable. As above, there is no training set. The "ground truth" for the device's characteristics is established through recognized industry standards, test methods, and scientific principles applied during the performance and biological testing.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).