(114 days)
The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device.
A. 24 Fr Venous Cannula
The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable length measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.
B. Introducer
The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque PVC material for visualization under fluoroscopy.
Below is the information regarding the acceptance criteria and study for the Protek Solo 24 Fr Venous Cannula Set, as extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "Conclusion" or "Acceptance criterion was identical to that of the predicate and was met in all tests.") | Reported Device Performance |
|---|---|---|
| Comparative Hemolysis | No difference in hemolysis levels between test articles and predicate controls over 6 hours. | No difference in hemolysis levels between test articles and predicate controls. |
| Pressure-Flow | Measured flow rates to exceed the smaller predicate at all levels of pressure difference across the cannula. Design specifications were met. | Measured flow rates exceed the smaller predicate at all levels of pressure difference across the cannula. Design specifications were met. |
| Tensile Strength | Identical to those of the predicate. | Met in all tests. |
| Pathway Integrity | Identical to that of the predicate. | Met in all tests. |
| Kink Radius | Identical to that of the predicate. | Met in all tests. |
| Stiffness | Established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury. | The cannula, the introducer, and the cannula/introducer assembly met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each individual test. It consistently refers to "all tests" or testing of "the cannula, the introducer, and the cannula/introducer assembly," implying that a sufficient number of units were tested to draw conclusions.
The data provenance is from bench-top testing conducted by Cardiac Assist, Inc. The document does not specify the country of origin of the data beyond the company's location in Pittsburgh, Pennsylvania, USA. The studies are retrospective in the sense that they are assessing conformance against predetermined criteria, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the document describes bench-top engineering and performance testing for a medical device (venous cannula and introducer), not a diagnostic or AI-assisted device that requires human expert review for ground truth establishment. The "ground truth" here is defined by engineering specifications and comparative performance against a predicate device.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as above. The tests performed are objective physical and performance measurements, not subjective evaluations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging interpretation or other scenarios where human reader performance is being evaluated and compared, typically in the context of AI assistance. The described tests are for the physical and functional characteristics of a medical device.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device or study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument (venous cannula and introducer), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for these tests was based on:
- Engineering specifications and design requirements for the new device.
- Comparative performance against legally marketed predicate devices (TandemHeart 21 Fr Venous Cannula and Protek Duo Veno-Venous Cannula Introducer), which serve as the established benchmark for safety and effectiveness for similar devices.
8. The Sample Size for the Training Set
This section is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above. There was no training set, as this is not an AI/ML device.
§ 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).