(30 days)
The Agilis NxT Steerable Introducer Dual-Reach™ is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Agilis™ NxT Steerable Introducer Dual-Reach™ set 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 13 F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with 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 ≥135° and counterclockwise ≥90°. Actual curve angles will vary. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The provided text is a 510(k) premarket notification for a medical device, the Agilis™ NxT Steerable Introducer Dual-Reach™. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance in a clinical or diagnostic context.
The document states that the device is a catheter introducer and its indications for use are "introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum."
The "study" referenced in the document is a non-clinical testing summary for design verification to ensure substantial equivalence to a predicate device, not a performance study in the sense of accuracy, sensitivity, or specificity for a diagnostic algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or specific outcomes in patients) or report such performance metrics. Instead, it indicates that "Design verification activities were performed and met the respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."
The types of testing performed, which would have their own internal acceptance criteria, are:
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical/Functional Performance | Met respective acceptance criteria for design verification. |
| Biocompatibility | Testing performed. |
| Sterility | Testing performed. |
| Packaging Integrity | Testing performed. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a submission for a physical medical device, not a software algorithm tested on a data set. The "testing" refers to non-clinical laboratory or engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a physical medical device. Ground truth, in the context of clinical expert review of data/images, is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a submission for a physical medical device.
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 is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of physical medical device, "ground truth" would be established through engineering specifications, material standards, and performance benchmarks for the physical properties and function of the device in a controlled environment.
8. The sample size for the training set
Not applicable. This is a submission for a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a submission for a physical medical device, not an AI/ML algorithm.
Summary from the document:
The Agilis™ NxT Steerable Introducer Dual-Reach™ is a physical medical device. The "study" mentioned in the document is a series of non-clinical design verification activities, biocompatibility, sterility, and packaging tests conducted in accordance with industry standards and guidance documents. These tests were performed to demonstrate that the modified device is substantially equivalent to its predicate device (Agilis™ NxT Steerable Introducer) and that all associated risks with the modifications were mitigated. The device is not a diagnostic algorithm or AI software, and therefore, typical performance metrics, sample sizes for data sets, expert involvement for ground truth, or MRMC studies are not applicable or described in this document.
§ 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).