(35 days)
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.
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).
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.
§ 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).