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The VasoPrep Surgical Marking Pen is intended for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft.

The VasoPrep Surgical Marking Pen is a single patient use sterile prescription use only marker intended for use on veins prior to or during Coronary-Assisted Bypass Graft (CABG) surgery. The marker (Figure 1) consists of a pen body, barrel, wick and cap with a wide chisel style applicator tip for delivery of ink to mark internal tissue. The formulation is non-toxic as used and is comprised of an ink material (FD&C Blue Dye #1) compounded into a carrier material (i.e., solvent). The wide chisel tip can deliver either a thin line of ink for precise marks or can be rotated 90° to deliver a wide stripe of ink.

This document describes a De Novo classification request for the VasoPrep Surgical Marking Pen, an internal tissue marker. The studies presented are non-clinical/bench studies, therefore, the concept of AI performance, ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and a standalone algorithm performance are not applicable.

1. Table of Acceptance Criteria and the Reported Device Performance:

The acceptance criteria and reported device performance are presented across several tables in the provided text. For clarity, they are consolidated and summarized below:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Human Saphenous Vein (HSV) segments: Used for "Internal Tissue Marking Ability" and "Effect of Dye on Human Vein Tissue" studies. The exact number of segments is not specified, but it refers to "segments" which implies a limited number for individual tests. The origin of the human tissue is not specified (e.g., country of origin). These are ex-vivo experiments (retrospective in the sense that the tissue has been harvested, but prospective for the purpose of the experiment itself).
• Porcine Saphenous Vein: Used for "Effect of Dye on Animal Vein Tissue" and product stability testing. The exact number of veins or samples is not specified. The origin is not specified. These are ex-vivo or animal model experiments.
• Animals for Biocompatibility (Guinea Pig): Used for Sensitization testing. A "guinea pig method" is mentioned, implying a standard number of animals for such a test (typically a small cohort).
• Sterilized and Aged Markers: Four markers were tested for product stability functionality, and two real-time aged markers were used for demarcation effectiveness and fluid volume.
• Toxicological Assessment Literature Studies: Canine, porcine, and murine models were used in literature studies for lifetime toxicity/carcinogenicity of FD&C Blue #1 dye. The number of animals in these literature studies is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a non-clinical/bench study. There is no mention of experts establishing a "ground truth" in the context of human interpretation or diagnostic accuracy. Performance criteria are based on objective physical, chemical, and biological measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a non-clinical/bench study. Adjudication methods are typically used in studies involving subjective human interpretation, which is not the case here.

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:

Not applicable. This is a non-clinical/bench study for a physical device (marking pen), not an AI-powered diagnostic tool.

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

Not applicable. This is a non-clinical/bench study for a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in these studies is based on objective scientific measurements and established standards for biocompatibility (e.g., non-cytotoxic, non-irritant), sterility (sterility assurance level), packaging integrity (visual, dye leak, peel tests), and performance characteristics (visible mark, no detrimental effect on tissue viability). It's a scientific and technical "ground truth" established through laboratory testing.

8. The sample size for the training set:

Not applicable. There is no AI or machine learning component, therefore no training set.

9. How the ground truth for the training set was established:

Not applicable. There is no AI or machine learning component, therefore no training set or ground truth for it. Any "training" or optimization of the pen's design or ink formulation would have been part of the product development process, not a formal training set as understood in AI/ML contexts.

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