(30 days)
The Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.
The Coaxial Introducer Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath. The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version. The Coaxial Introducer Set is provided in sterile and non-sterile configurations.
The provided document is a 510(k) summary for a medical device (Coaxial Introducer Set) and does not describe acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device. Instead, it details in-vitro bench testing conducted to assure reliable design and performance in accordance with ISO standards and/or internal procedures for a physical medical device. It also includes information about biocompatibility testing.
Therefore, many of the requested categories for AI/ML device studies cannot be populated from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions in-vitro testing but does not provide specific acceptance criteria or quantitative performance metrics for each test. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench/Performance Data: | |
| Guidewire Passage | Assured reliable design and performance (qualitative statement) |
| Air Leakage | Assured reliable design and performance (qualitative statement) |
| Liquid Leakage | Assured reliable design and performance (qualitative statement) |
| Force at Break | Assured reliable design and performance (qualitative statement) |
| Simulated Use | Assured reliable design and performance (qualitative statement) |
| Biocompatibility: | |
| ISO 10993 requirements | Materials meet the requirements (qualitative statement) |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to AI/ML model evaluation, not physical device testing.
4. Adjudication method for the test set: Not applicable. This pertains to AI/ML model evaluation.
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 document describes a physical medical device, not an AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a physical medical device, not an AI algorithm.
7. The type of ground truth used: For the bench testing, the "ground truth" would be objective measurements and observations against established engineering specifications and ISO standards. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set: Not applicable. This pertains to AI/ML model training.
9. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML model training.
Summary based on the provided text:
The Coaxial Introducer Set underwent in-vitro bench testing for:
- Guidewire Passage
- Air Leakage
- Liquid Leakage
- Force at Break
- Simulated Use
These tests were performed "to assure reliable design and performance in accordance with ISO standards and/or internal procedures." The specific acceptance criteria and the quantitative results (e.g., "passed 100/100 guidewire passages," or "leakage rate was X") are not provided in this summary.
Additionally, biocompatibility testing was performed, and the results demonstrated that the materials used meet the requirements of ISO 10993.
The conclusion states that the proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols, and are substantially equivalent to the legally marketed predicate devices.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).