(31 days)
The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
This document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based product.
The information provided describes design verification activities for a hardware medical device (steerable introducer), not an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable.
Here's an analysis based on the provided text, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are safe and effective." However, specific numerical acceptance criteria and their corresponding reported device performance values are not detailed in this summary. The document lists the types of testing performed and the standards met.
| Acceptance Criterion (Type of Test) | Reported Device Performance (Implied) |
|---|---|
| Performance testing of modified design | Met acceptance criteria (no specific numerical values provided) |
| Biocompatibility testing | Met acceptance criteria (no specific numerical values provided) |
| Sterility testing | Met acceptance criteria (no specific numerical values provided) |
| Shelf-life testing | Met acceptance criteria (no specific numerical values provided) |
| Adherence to ISO 80369-7 (Small-bore connectors) | Compliance confirmed |
| Adherence to ANSI AAMI ISO 10993-1 (Biological evaluation) | Compliance confirmed |
| Adherence to ANSI AAMI ISO 11135 (Sterilization) | Compliance confirmed |
| Adherence to ANSI AAMI ST72 (Bacterial endotoxins) | Compliance confirmed |
| Adherence to ISO 11607-1 & -2 (Packaging) | Compliance confirmed |
| Adherence to ISO 15223-1 & ISO 20417 (Symbols & Information to be supplied) | Compliance confirmed |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document describes physical device testing, not an AI/algorithm-based test set with data provenance. "Test set" here refers to the physical devices subjected to various engineering and biological tests. The sample sizes for each specific test (e.g., number of devices for durability, sterility, or biocompatibility) are not provided in this summary, but would be part of the full design verification report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI algorithms interpreting medical images or data. For a physical medical device like an introducer, "ground truth" is typically established by engineering specifications, validated test methods, and biological safety standards. Experts involved would be engineers, microbiologists, and other technical specialists relevant to the specific tests performed (e.g., biocompatibility specialist, sterilization expert).
4. Adjudication Method for the Test Set
Not applicable. This refers to methods for reconciling differing expert opinions on ground truth for AI algorithms. For device performance testing, adjudication involves comparing test results against predefined acceptance criteria from engineering specifications and regulatory standards.
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 hardware device (catheter introducer), not an AI system that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware device, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering specifications, international and national standards (e.g., ISO, ANSI AAMI listed), and regulatory requirements for mechanical performance, material compatibility, biocompatibility, and sterility. For example, for biocompatibility, the ground truth is that the materials do not elicit an adverse biological response as defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This refers to AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This refers to AI/machine learning models.
Summary of Study Type:
The study referenced is a series of non-clinical design verification activities and laboratory tests. These tests were conducted to demonstrate that the modifications made to the Agilis NxT Steerable Introducer Dual-Reach™ (the subject device) did not adversely affect its safety and effectiveness and that it continues to meet established performance, biological safety, and sterility standards, making it substantially equivalent to its predicate device. This is typical for a 510(k) submission for a modified hardware device.
§ 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).