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The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The 9F Prelude IDeal Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 9F Prelude Ideal Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French size 9F) and is designed to accept 0.038" diameter guide wires. The 9F Prelude Ideal Hydrophilic Sheath Introducer is marketed with the following components: quide wire, metal access needle, quide wire insertion device.

This document describes the 510(k) summary for the 9F Prelude IDeal Hydrophilic Sheath Introducer, a medical device. It does not contain information about an AI/ML powered device, therefore, the requested information elements (1-9) which are related to AI/ML device studies and ground truth establishment are not applicable.

The document focuses on demonstrating the substantial equivalence of the 9F Prelude IDeal Hydrophilic Sheath Introducer to its predicate device (K173750 and K142829) through performance testing.

Here's the relevant information about the non-clinical performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, referencing applicable international and internal standards. It generally states that the device "met the predetermined acceptance criteria applicable to the performance of the device." However, specific numerical acceptance criteria and the exact reported device performance values are not provided in this summary. The table below outlines the tests performed:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided document for each specific test.
• Data Provenance: The tests are "Nonclinical performance data" and internal validation tests. The provenance is internal to the manufacturer, Merit Medical Systems, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is a non-clinical device filing, and expert adjudication for ground truth (as in a clinical study or AI/ML model evaluation) is not applicable or described. The tests are based on engineering and material science standards.

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

• Not applicable for non-clinical performance testing.

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 not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

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

• The "ground truth" for this device's performance is established by meeting the requirements of recognized international and internal engineering, material, and sterility standards (e.g., ISO, ASTM). These standards define objective, measurable criteria for device functionality and safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

Summary of Conclusions from the Document:

The 9F Prelude IDeal Hydrophilic Sheath Introducer demonstrated substantial equivalence to its predicate devices by meeting predetermined acceptance criteria in nonclinical performance tests. These tests included manual testing against international standards, coating adhesion and particulate testing, transportation integrity, biocompatibility, sterilization validation, and accelerated aging. The differences from the predicate (larger diameter, different hemostasis valve, colorants, tubing material, removal of compression sleeve, and dilator material change) and minor changes in indications for use (exclusion for radial artery use and specific access needle) were deemed not to raise new questions of safety or effectiveness.

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