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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

The MC2X™ Multi-Stage Venous Cannulae are cannula with with with an approximate The MC2X™ Multi-Stage Vehous Calimitat are camage and with an appoximate side ports in the distal tip, with ported arrial basket drainage and with an any side ports in the distal tip, with ported annor ousset online the cannula. All are overall length of 15 ¼". Insertion depth marks and in positioning the cannula. All are a overall length of 15 % . Insertion depth mains are single use. The devices may include a supplied sterile, are non-pyrogenic and are single use. The devices may include atte supplied sterile, are non-pyrogenc and are smgre ass. The artistion with tubing attached with a quick disconnect.

This 510(k) summary describes a resubmission for the MC2X™ Multi-Stage Venous Cannula, which is a Class II device used in cardiopulmonary bypass surgery. The resubmission is for a modified version of the previously cleared MC2X™ Multi-Stage Venous Cannula (K031776).

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria related to a novel device's clinical performance. Therefore, typical acceptance criteria tables and detailed study results demonstrating clinical efficacy or diagnostic accuracy are not present.

However, based on the provided text, we can infer the acceptance criteria for determining substantial equivalence and describe the study that demonstrates the device meets these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this resubmission are implicitly defined by the demonstration of substantial equivalence to the predicate device. The "study" conducted is a series of bench tests and a comparison of characteristics to the predicate device.

• Approximate side ports in the distal tip.
• Ported atrial basket drainage.
• Overall length of 15 ¼ inches.
• Insertion depth marks.
• Sterile, non-pyrogenic, single-use status.
• Option for tubing attached with a quick disconnect.
  Changes: The new models have "a thing basket, a slight change to the shape of the tip, and a three piece rather than one piece construction." These changes are implicitly deemed acceptable based on testing. |
  | Material Composition | The materials used in the modified device should be equivalent or demonstrably safe and effective for the intended use. | Implied to be equivalent or suitable for the intended use, as no specific material changes raising new safety/effectiveness questions are highlighted beyond structural construction. |
  | Functional Performance (Bench Testing) | The device must meet established performance benchmarks for critical functions in a controlled environment, demonstrating no adverse impact from design changes. | Qualification tests included:
• Visual inspection
• Collapse test
• Flow test
• Kink test
• Tensile testing
  Conclusion: These tests "were performed to qualify the devices," indicating successful performance and implicitly meeting internal specifications derived from the predicate device's performance. |
  | Intended Use/Indications for Use (IFU) | The fundamental intended use of the device should remain the same as the predicate device. | Predicate IFU: "venous drainage via the right atrium and vena cava..."
  Modified Device IFU: "venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery."
  The IFU is stated to be essentially the same: "The predicate devices also provide drainage of the vena cava at the vena cava at the drainage indications for use." The minor rephrasing for "simultaneously" does not indicate a new intended use. |
  | Safety and Effectiveness (Implicit from Substantial Equiv.) | The modified device should be as safe and effective as the legally marketed predicate device. | The conclusion states: "Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implicitly means that safety and effectiveness are considered maintained. |

Study Details

The "study" conducted for this 510(k) submission is a series of bench tests and a direct comparison to the predicate device's characteristics. This is a retrospective comparison to an already cleared device, supplemented by prospective bench testing on the new design.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as "sample size" in the context of a clinical trial. For bench testing, the sample size would refer to the number of devices or components tested for each specific qualification test (e.g., number of cannulae subjected to flow testing). This number is not provided in the summary.
   • Data Provenance: The data is generated internally by Medtronic Perfusion Systems through bench testing ("Qualification including visual inspection, collapse, flow, kink and tensile testing were performed to qualify the devices.") and a direct comparison of specifications to their own previously cleared predicate device (K031776). This is prospective data generation for the physical properties of the new device, but a retrospective comparison to the predicate device's cleared characteristics and performance.
   • Country of Origin: Implied to be the USA, where Medtronic Perfusion Systems is located.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This type of information is not applicable to a 510(k) submission based on bench testing and substantial equivalence. Ground truth in this context is established by engineering specifications, validated test methods, and regulatory requirements rather than subjective expert assessment of images or clinical outcomes on a test set.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert opinions on clinical endpoints or image interpretations. This submission relies on objective engineering tests.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was NOT done. This type of study investigates diagnostic efficacy or reader performance, typically with AI-assisted interpretation of medical images. The device in question is a physical medical device (cannula), not an AI-driven diagnostic tool.

5. Standalone (Algorithm Only) Performance Study:

   • No, a standalone performance study in the context of an algorithm's performance was NOT done. This submission is for a physical medical device, not an algorithm or AI. The "standalone" performance here refers to the device's functional integrity as demonstrated in bench tests.

6. Type of Ground Truth Used:

   • The "ground truth" for this submission is established through:
     • Engineering specifications and design requirements: These define the target performance and characteristics for the device.
     • Physical measurements and validated bench testing: Objective data from tests like flow, tensile, collapse, and kink provide the "truth" about the device's physical and functional properties.
     • Regulatory standards and predicate device characteristics: The established safety and effectiveness profile of the predicate device (K031776) serves as the benchmark against which the modified device's equivalence is assessed.

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of an AI/ML algorithm. This device is a physical medical device. The "training" in the engineering sense would be the iterative design and development process, which doesn't involve a distinct "training set" of data for an algorithm.

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

   • Not applicable. See point 7.

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