(21 days)
The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.
The St. Jude Medical Agilis™ NxT Stecrable Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counter-clockwise ≥ 90°15 The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
This document, K083083, is a 510(k) summary for the Agilis™ NxT Steerable Introducer Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the St. Jude Medical Agilis™ NxT Steerable Introducer (K061363).
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Agilis™ NxT Steerable Introducer. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Performance | Meets product specifications and performance requirements (as determined by bench testing). | "Results of the testing demonstrate that the Agilis™ NxT Stecrable Introducer meets product specifications and performance requirements." |
| Material Equivalence | Utilizes many of the same materials as the predicate device. | "The Agilis™ NxT Steerable Introducer (40cm) utilizes many of the same materials..." |
| Design Principles | Follows similar design principles as the predicate device. | "...and design principles..." |
| Fundamental Technology | Fundamental scientific technology remains unchanged from the predicate device. | "...and the fundamental scientific technology of the device remain unchanged." |
| Indications for Use | The indications for use are either identical or fall within a broader statement of the predicate. | "The Agilis™ NxT Steerable Introducer (40cm) has an Indication for Use statement that is included in the broader Indications for Use statement of the predicate Agilis™ NxT Steerable Introducer." |
Note: The acceptance criteria are largely implied by the statement of "substantial equivalence" and the general successful outcome of non-clinical testing. Specific numerical or threshold-based performance metrics are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" which typically involves testing a sample size of devices, but the specific number is not provided.
- Data Provenance: The testing appears to be non-clinical bench testing, meaning it was conducted in a laboratory setting, not with human or animal subjects. Details on the geographic origin are not mentioned, but it would typically be internal testing by the manufacturer (St. Jude Medical). It is retrospective in the sense that the test results confirm the design choices made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not available in the provided document. The study described is a non-clinical bench test. "Ground truth" in the context of expert review typically refers to clinical studies where human experts (e.g., radiologists, pathologists) interpret data (e.g., images, case files) to establish a correct diagnosis or outcome. For bench testing of a medical device like an introducer catheter, the "ground truth" is typically defined by engineering specifications, physical measurements, and established testing standards, not by expert human review in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not available. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers in clinical studies to establish a consensus ground truth. Since this study is a non-clinical bench test validating device performance against specifications, such a method would not be used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this document. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to evaluate the performance of human readers with and without AI assistance. This document describes the substantial equivalence of a physical medical device (an introducer catheter) based on bench testing.
Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable and not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this concept is not applicable to the device described. A "standalone" performance evaluation refers to the performance of an algorithm or AI model without human intervention. The Agilis™ NxT Steerable Introducer is a physical medical device. Its performance is evaluated through engineering tests, not as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this study would be derived from:
- Engineering Specifications: Pre-defined performance parameters and design requirements for the introducer catheter.
- Physical Measurements and Standards: Data obtained from bench tests (e.g., material strength, deflection angles, hemostasis valve integrity, flow rates) are compared against established industry standards, design tolerances, and the performance characteristics of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and therefore not available. A "training set" is used for machine learning algorithms. The Agilis™ NxT Steerable Introducer is a physical medical device, not an AI algorithm. Its development and validation are based on engineering design, manufacturing processes, and physical testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no "training set" in the context of this 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).