Search Results

The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the SAPIEN 3 Ultra transcatheter heart valves.

Device Description

The Edwards eSheath Introducer Set contains two dilators and a sheath with hydrophilic coating, and loader packaged with an Edwards delivery system. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES).

AI/ML Overview

This document describes a 510(k) premarket notification for the Edwards eSheath Introducer Set. The review focuses on demonstrating substantial equivalence to previously cleared predicate devices and expanding the indications for use.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for each test. Instead, it states that "all results were acceptable" for the design verification and validation tests and that "performance testing has demonstrated that safety and efficacy are not adversely impacted." The tests themselves act as the criteria to be met.

Test Type	Reported Device Performance
Visual Inspection	Successfully completed and acceptable
Dimensional Inspection	Successfully completed and acceptable
Radiopacity/Visualization	Successfully completed and acceptable
Guidewire Compatibility	Successfully completed and acceptable
Hemostasis	Successfully completed and acceptable
Lubricity and Durability of Sheath	Successfully completed and acceptable
Kink Resistance	Successfully completed and acceptable
Seam Return After Expansion	Successfully completed and acceptable
Bond Strength	Successfully completed and acceptable
Device Interaction	Successfully completed and acceptable
Hydrophilic Coating Characterization	Successfully completed and acceptable
USP Particulate Test	Successfully completed and acceptable
Loader Peel Test	Successfully completed and acceptable
Material Verification	Successfully completed and acceptable
Sterilization Validation	Successfully completed and acceptable
Biocompatibility Tests	Successfully completed and acceptable for Cytotoxicity, Hemocompatibility, Systemic Toxicity, Material Mediated Pyrogenicity, Irritation/Intracutaneous Reactivity, Sensitization, Chemical Acceptability, Thrombogenicity
Packaging Integrity	Successfully completed and acceptable
Shelf Life Verification	Successfully completed and acceptable
USP Physico-Chemical Test for Plastic Closures	Successfully completed and acceptable

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "Performance Testing for the Edwards eSheath Introducer Set (model 914ES and 916ES) was previously provided in Section 14 of 510(k) K152225 and K162184" and "Performance Testing for the Edwards eSheath Introducer Set (model 914ES) indication expansion was previously provided in the FDA PMA140031/S088 and PMA140031/S091." The implication is that the sample sizes were sufficient for the original submissions and remain valid for this expanded indication.
Data Provenance: The document does not state the country of origin of the data or whether the studies were retrospective or prospective. Given these are premarket submissions for a medical device in the US, the testing would typically be conducted under GLP (Good Laboratory Practice) guidelines and would be considered prospective for the purpose of demonstrating device performance against specific criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable and not provided in the context of this device. The testing described is primarily mechanical, material, and biological performance testing, not diagnostic performance where expert ground truth is typically established (e.g., image interpretation). The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements (e.g., dimensions, bond strength, particulate count) or standardized biological evaluations rather than subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned because this device is an introducer set, not a diagnostic or AI-driven imaging device that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical medical device (an introducer set), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be categorized as:

Engineering Specifications and Standards: For dimensional, mechanical (bond strength, kink resistance, lubricity, seam return, loader peel), and physical (radiopacity, guidewire compatibility, hemostasis, device interaction) tests.
USP (United States Pharmacopeia) Standards: For particulate tests and physico-chemical tests for plastic closures.
ISO/FDA Biocompatibility Guidelines: For biocompatibility tests (cytotoxicity, hemocompatibility, systemic toxicity, pyrogenicity, irritation, sensitization, chemical acceptability, thrombogenicity).
Sterilization Industry Standards: For sterilization validation.
Packaging and Shelf Life Standards: For packaging integrity and shelf life verification.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

Ask a Question

Ask a specific question about this device

Page 1 of 1