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These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Device Description

DLP® Single Stage Venous Cannulae devices are used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of wirewound, kink-resistant Polyvinyl Chloride (PVC) plastisol bodies with a nominal outer diameter of 12Fr to 40Fr (in 2Fr increments) and overall lengths from 12 inches to 15 inches. These cannulae are available in Carmeda® Bioactive Surface coated and uncoated versions. All DLP® Single Stage Venous Cannulae are provided as sterile, nonpyrogenic, disposable, single use devices.

Carmeda® BioActive Surface is a durable, non-leaching end point attached heparin Biosurface that mimics the heparin sulfate naturally found on the vascular endothelium lining the circulatory system. Carmeda® provides thromboresistance, enhanced biocompatibility, and enhanced blood compatibility while reducing platelet activation and adhesion formation.

AI/ML Overview

This 510(k) premarket notification is for a modified version of the DLP® Single Stage Venous Cannula product family. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through direct comparison, rather than presenting a study with specific acceptance criteria and performance data for the modified device itself.

Therefore, many of the requested data points (acceptance criteria, specific study performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable or available within this document. The submission relies on the established safety and effectiveness of the predicate devices.

Here's an overview based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated for performance metrics. The underlying acceptance criterion for this 510(k) is demonstrating substantial equivalence to predicate devices.	The submission concludes that "Medtronic has demonstrated that the modifications made to the DLP® Single Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices." The FDA concurred with this determination.

Acceptance Criteria

Reported Device Performance

Not explicitly stated for performance metrics. The underlying acceptance criterion for this 510(k) is demonstrating substantial equivalence to predicate devices.

The submission concludes that "Medtronic has demonstrated that the modifications made to the DLP® Single Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices." The FDA concurred with this determination.

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

Not applicable. This submission is a 510(k) for device modification, relying on substantial equivalence to predicate devices, rather than a new clinical study with a test set of data. The "test" in this context refers to engineering and design verification, not a clinical data evaluation against a ground truth.

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

Not applicable. No external "ground truth" establishment by experts in the context of a clinical test set is described. The assessment is based on a comparison to predicate devices and engineering evaluations.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method for a clinical test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study was not conducted as this is a 510(k) for a modified device, focusing on substantial equivalence to predicate devices.

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

Not applicable. This device is a medical cannula, not an algorithm or software. Therefore, the concept of "standalone performance" in this context is irrelevant.

7. The Type of Ground Truth Used:

Substantial Equivalence to Predicate Devices. The "ground truth" for this 510(k) decision is the established safety and effectiveness of the legally marketed predicate devices (K842374, K022272, and K111972). The submission aims to show that the modified device is as safe and effective as these predicates.

8. The Sample Size for the Training Set:

Not applicable. No training set for a machine learning algorithm or similar is mentioned, as this is a physical medical device.

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

Not applicable. There is no training set mentioned.

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