(83 days)
The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.
The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.
This document describes the acceptance criteria and the study for the 82cm Agilis NxT™ Steerable Introducer.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface Visual Standard | Pass | Pass |
| Usable Shaft Length | Pass | Pass |
| Curve Angle | Pass | Pass |
| Deflection Durability | Pass | Pass |
| Shaft Kink | Pass | Pass |
| Curve Retention | Pass | Pass |
| Shaft Torque Test | Pass | Pass |
| Tip Tensile | Pass | Pass |
| Sheath/Dilator | Pass | Pass |
| Distal tip inner diameter | Pass | Pass |
| Insertion Forces | Pass | Pass |
| Radiopacity | Pass | Pass |
| 3-way Stopcock | Pass | Pass |
| Shaft to Hub Tensile | Pass | Pass |
| Stopcock to Hub bond | Pass | Pass |
| Freedom from Leaks | Pass | Pass |
| Luer Taper | Pass | Pass |
| Lure Stress Cracking | Pass | Pass |
| Sterilization | ||
| EtO residuals | Meets specifications | Pass |
| Lethality | Meets specifications | Pass |
| Natural product sterility | Meets specifications | Pass |
| Bacteriostasis | Meets specifications | Pass |
| Fungistasis | Meets specifications | Pass |
| Bioburden | Meets specifications | Pass |
| LAL testing | Meets specifications | Pass |
| Packaging | ||
| Performance Testing of Shipping Containers (ASTM D4169-05) | Maintain integrity and sterile barrier | No failures reported |
| Visual Inspection (ASTM F1886-98) | Maintain integrity and sterile barrier | No failures reported |
| Seal Strength (ASTM F88-00) | Maintain integrity and sterile barrier | No failures reported |
| Bubble Leak (ASTM F2096-04) | Maintain integrity and sterile barrier | No failures reported |
| Product shelf life testing | Meets specifications | Pass |
| Biocompatibility | ||
| Cytotoxicity | Pass | Pass |
| Sensitization | Pass | Pass |
| Intracutaneous Reactivity (Irritation) | Pass | Pass |
| Systemic Toxicity (acute, includes pyrogenicity) | Pass | Pass |
| Chemical Characterization / Gas Chromatography with Mass Spectrometry | Pass | Pass |
| Chemical Characterization / Inductively Coupled Plasma (ICP) | Pass | Pass |
| Partial Thromboplastin Time - PTT | Pass | Pass |
| Pyrogenicity | Pass | Pass |
| Hemocompatibility - Hemolysis | Pass | Pass |
| Hemocompatibility - Complement Activation System | Pass | Pass |
| Hemocompatibility - Thrombosis | Pass | Pass |
| Chemical Characterization / Fourier Transform Infrared Spectroscopy (FTIR) | Pass | Pass |
| Chemical Characterization / Physicochemical Non-volatile Residue (NVR) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing for the device, not a human clinical trial involving a "test set" of patients or data in the typical sense for evaluating diagnostic accuracy or clinical outcomes. The "test set" here refers to the actual devices or components tested.
- Sample Size: The specific sample size for each individual bench test (e.g., how many devices underwent a Shaft Kink test) is not explicitly stated in the provided text. The results are simply reported as "Pass."
- Data Provenance: The tests are conducted by the manufacturer, St. Jude Medical, which implies internal testing. The data provenance is retrospective in the sense that these tests were performed on manufactured devices to verify their specifications. The country of origin of the data is implicitly the manufacturing or testing location of St. Jude Medical, likely the United States (Minnetonka, MN, as listed for the submitter).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation is based on bench testing of device specifications, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies, particularly for interpreting diagnostic images or clinical endpoints where multiple experts might disagree. Bench tests have objective Pass/Fail criteria based on predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study assesses the impact of a device (like an AI algorithm) on human reader performance, which is not relevant for a steerable introducer device's bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an electro-mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is the defined product specifications and performance requirements. For example, the "Curve Angle" test would have a specific angle tolerance as its ground truth, and the device either meets it ("Pass") or fails to. For biocompatibility tests, the ground truth is established by standards (e.g., ISO 10993) and the biological response observed meets the defined acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/ML algorithm. The device design and materials are based on engineering principles and previous predicate devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as above.
§ 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).