(171 days)
The Agilis™ ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.
The St. Jude Medical Agilis ES Steerable Introducer consists of a 94cm, 8.5F dilator, a 180cm, 0.032" guidewire; and a 71cm (usable length), 8.5F steerable sheath. It is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer constructed of a polymer shaft that incorporates three platinum/iridium electrodes, the primary use of which is visualization on the EnSite™ System. The electrodes may also be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for 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.
The provided text describes a 510(k) premarket notification for the Agilis™ ES Steerable Introducer. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a medical AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (like sample size, ground truth definition, MRMC studies, training set details) are not applicable to this type of medical device submission.
However, I can extract the information related to the non-clinical testing performed and the general intent of the submission.
Here's a breakdown based on the provided text, indicating "Not Applicable" where the information is not relevant to a traditional medical device like an introducer:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to meeting "product specifications and performance requirements" and demonstrating "substantial equivalence" to predicate devices. Specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are not presented in this summary, as they are not typically required for a Class II non-AI device of this type during a 510(k) submission.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Meets Product Specifications | "Agilis ES Steerable Introducer meets product specifications and performance requirements." |
| Meets Performance Requirements | "Agilis ES Steerable Introducer meets product specifications and performance requirements." |
| Demonstrated Safety | "Assessment of the device safety performance..." (GLP Animal Study) |
| Able to Meet Intended Use | "...demonstration of the ability to meet its intended use." (GLP Animal Study) |
| Substantial Equivalence to Predicate | "The Agilis ES Steerable Introducer has similar indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided... SJM's Agilis ES Steerable Introducer has been shown to be substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of AI/ML. The document refers to "Bench and GLP Animal testing." The number of animals used in the GLP animal study is not specified in this summary.
- Data Provenance: The animal study is a GLP (Good Laboratory Practice) study, which implies a controlled, prospective study environment, likely in a laboratory setting or animal research facility. The country of origin is not specified but generally for US FDA submissions, studies are either US-based or comply with international GLP standards acceptable to the FDA.
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 physical medical device, not an AI/ML system requiring expert-established ground truth on images or data. The evaluation of performance and safety would be conducted by clinicians, veterinarians, and technical staff involved in the GLP animal study and bench testing, based on established protocols and endpoints.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 physical medical device, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance evaluation described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used
- For the GLP Animal Study: The "ground truth" refers to the physiological outcomes, device function within the living system, and safety observations as determined by direct measurement, clinical assessment, and potentially necropsy findings in the animals.
- For Bench Testing: The "ground truth" is based on engineered specifications and physical measurements (e.g., dimensional accuracy, deflection angles, electrical properties, leak tests, bond strength), assessed against predetermined thresholds or ranges.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that utilizes a training set. The device design is based on engineering principles and iterative development, not data-driven machine learning.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device Performance (from the document):
The Agilis ES Steerable Introducer underwent both bench and GLP (Good Laboratory Practice) animal testing. The results of these tests demonstrated that the device "meets product specifications and performance requirements." The GLP animal study specifically assessed the device's safety performance and its ability to meet its intended use. The submission concludes that "No clinical testing was required" for this device, and it was found to be substantially equivalent to its predicate devices.
§ 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).