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The ProtekDuo Mini Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

Device Description

The ProtekDuo Mini Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual Lumen Veno-Venous Cannula and a 15.5 Fr. Introducer is designed to accept a standard 0.038 inch guidewire. The ProtekDuo Mini Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The ProtekDuo Mini Veno-Venous Cannula (Figure 5-1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 5-1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.

The introducer (Figure 5-2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the ProtekDuo Mini Veno-Venous Cannula Set meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criterion (identical to predicate unless otherwise noted)	Reported Device Performance
Comparative Hemolysis	No difference in hemolysis levels between test articles and predicate controls.	No difference in hemolysis levels between test articles and predicate controls.
Pressure-Flow	Measured flow rates must exceed the longer predicate at all levels of pressure difference across the cannula. Design specifications were met (specifics not detailed).	Measured flow rates exceed the longer predicate at all levels of pressure difference across the cannula. Design specifications were met.
Tensile Strength	Identical to those of the predicate.	Acceptance criteria were identical to those of the predicate and were met in all tests.
Pathway Integrity	Identical to that of the predicate.	Acceptance criterion was identical to that of the predicate and was met in all tests.
Kink Radius	Identical to that of the predicate.	Acceptance criterion was identical to that of the predicate and was met in all tests.
Stiffness	Established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury (specific values not detailed).	The cannula, the introducer, and the cannula/introducer assembly met acceptance criteria established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury.

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

The document does not specify the exact sample sizes (number of devices, repeats per test, etc.) for the non-clinical tests conducted. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature, but these are bench-top non-clinical tests.

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

Not applicable. This is a non-clinical device performance study, not a study involving human interpretation of data where expert ground truth would be required.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device performance study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical medical device, not an AI algorithm. The performance described is for the device itself.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" or reference was based on established engineering principles, design specifications, and direct measurement of the device's physical properties and performance against predetermined criteria (often derived from the predicate device's performance or industry standards).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. This is a physical medical device.

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