(90 days)
The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.
The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.
The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.
This document describes the Steerable Introducer 8.5F, a medical device for introducing cardiovascular catheters. The information provided focuses on the device's design, intended use, and the performance data submitted to the FDA for 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined with numerical targets in the provided text. Instead, the document states that the device was tested to "meet the device intended use and to ensure conformance to the product specifications" and "meets all its physical and performance specifications." The performance data section lists the types of tests conducted and generally states that the device "passed" or "meets" these specifications.
Therefore, the table can be constructed as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to product specifications | Meets all physical and performance specifications |
| Shaft deflection | Tested and met specifications |
| Simulated Use | Tested and met specifications |
| Torsional stiffness | Tested and met specifications |
| Radiopacity visualization | Tested and met specifications (distal tip and dilator are radiopaque) |
| Hemostasis | Tested and met specifications |
| Leak testing | Tested and met specifications |
| Guidewire compatibility | Tested and met specifications |
| Transseptal needle compatibility | Tested and met specifications |
| Distribution tests | Tested and met specifications |
| Usability studies | Tested and met specifications |
| Shelf life (functional and mechanical integrity) | Passed 13-month accelerated age study; not compromised post-aging |
| Biocompatibility (ISO 10993-1 for limited exposure) | Satisfies ISO 10993-1 requirements |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests listed (e.g., shaft deflection, simulated use, leak testing). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench testing and laboratory studies conducted as part of the device development and regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are primarily performance and safety tests for a physical medical device, not diagnostic or AI-driven systems requiring ground truth established by medical experts in the traditional sense.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment where disagreements in interpretation need to be resolved. The studies described are engineering and biological performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic aids (like AI algorithms) by comparing human readers' performance with and without the aid. The Steerable Introducer 8.5F is a physical medical device, not a diagnostic AI system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an "algorithm only without human-in-the-loop performance" was not done. This device is a physical tool, not an algorithm. The performance data relates to the physical and mechanical properties of the device itself.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance studies would be the objective measurements and engineering standards (e.g., a shaft deflecting to a certain angle, a guidewire fitting, no leaks under specific pressure) that define whether the device meets its specifications and intended function. These are inherent physical properties or design requirements.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device. The device's design is based on engineering principles and similarities to predicate devices, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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).