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The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery.

The Sarns Two Stage Venous Return Catheters with Duraflo Treatment, Venoatrial Catheters with Duraflo Treatment, and the Dual Stage Venous Return Catheters with Duraflo Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardio pulmonary bypass surgery.

The only difference between the Sarns Venous Return Catheters with Duraflo® Treatment and the Sarns Venous Return Catheters is the addition of the Duraflo® Treatment. As a result of this process, a layer of heparin is deposited on the inside and outside of the catheter tip, tube, and connector.

As with their predicate devices, all of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices. The Sarns Venous Return Catheters with Duraflo® Treatment are available in sizes ranging from 8 French to 51 French. (The French size is the outer diameter of the catheter in millimeters multiplied by three.). The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are available as a single tube. The Sarns Two Stage, Venoatrial, and Dual Stage Venous Return Catheters with Duraflo® Treatment consist of two differently-sized tubes. Many different models of the Sarns Venous Return Catheters with Duraflo® Treatment are available with wire-reinforced tubing. Some models of the multi-stage versions of the Sarns Venous Return Catheters with Duraflo® Treatment have an integral connector. Additionally, the Sarns Venous Return Catheters with Duraffo® Treatment have been coated with heparin via the Duraflo® Treatment process.

This document describes a 510(k) submission for Sarns Venous Return Catheters with Duraflo® Treatment, which are substantially equivalent to existing Sarns Venous Return Catheters. The only difference is the addition of a Duraflo® Treatment, which deposits a layer of heparin on the catheters. Therefore, the acceptance criteria and supporting study are focused on demonstrating that the addition of the Duraflo® Treatment does not negatively affect the performance or safety of the device, and that the new treated catheters perform as intended and are equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: "selected models were chosen as being representative of the technological attributes of all models of Sarns Venous Return Catheters with Duraflo® Treatment." The exact number of models tested is not specified in the provided text.
• Data Provenance: The study was a non-clinical performance study conducted by the device manufacturer, 3M Health Care, in the USA. It is a prospective study in the sense that the new Duraflo® treated catheters were tested for the purpose of demonstrating substantial equivalence.

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

This information is not provided in the given text. The study described is a non-clinical performance study, likely involving engineering and material science evaluations, rather than studies requiring expert medical interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a non-clinical performance assessment, not one requiring adjudication of expert opinions on diagnostic interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a medical device (catheter) with a change in coating, and not an AI-powered diagnostic product.

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

A standalone performance study, as typically understood for AI algorithms, was not done. This submission is for a physical medical device.

7. The Type of Ground Truth Used

For the non-clinical performance studies, the "ground truth" would be established by:

• Performance Specifications: Pre-defined engineering and functional specifications for the catheters (e.g., flow rates, material strength, coating integrity, biocompatibility, sterility).
• Predicate Device Performance: The established and validated performance characteristics of the currently marketed Sarns Venous Return Catheters. The new device's performance was compared against these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for an AI model.

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