(109 days)
The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.
The Edwards eSheath Introducer Set consists of a sheath and 2 introducers. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES). The 14 French introducer set is used to facilitate introduction of the 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16 French introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.
The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted.
A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals (valves) to provide hemostasis: a duckbill seal, a disc seal, and a cross slit seal. The housing also includes flushport tubing and a stopcock to allow for flushing of the sheath.
Two introducers are provided to aid in the introduction of the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The introducers are radiopaque and feature a tapered tip and guidewire lumen.
Here's an analysis of the provided text regarding the Edwards eSheath Introducer Set, focusing on acceptance criteria and the study that proves the device meets them. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive "study" in the academic sense of proving efficacy through clinical trials. Therefore, some of the requested information may not be present as it pertains more to clinical studies of diagnostic AI devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the Edwards eSheath Introducer Set. Instead, it lists the types of non-clinical tests performed to demonstrate that "performance characteristics... are equivalent to the predicates, and to verify that design requirements are satisfied." The stated outcome for all tests is "successfully completed."
| Acceptance Criteria Category (Implicit) | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Physical Integrity / Visual Quality | Visual Surface Inspection | Successfully completed (meets design requirements) |
| Dimensional Accuracy | Dimensional Inspection | Successfully completed (meets design requirements) |
| Imaging Visibility | Radiopacity/Visualization | Successfully completed (meets design requirements) |
| Functional Compatibility | Guidewire Compatibility | Successfully completed (meets design requirements) |
| Hemostasis Control | Hemostasis | Successfully completed (meets design requirements) |
| Ease of Use / Durability | Lubricity and Durability of the Sheath | Successfully completed (meets design requirements) |
| Structural Resilience | Kink Resistance | Successfully completed (meets design requirements) |
| Expandability / Return Capability | Seam Return After Expansion | Successfully completed (meets design requirements) |
| Component Strength | Bond Strength | Successfully completed (meets design requirements) |
| Interoperability | Device Interaction | Successfully completed (meets design requirements) |
| Surface Properties | Hydrophilic Coating Characterization | Successfully completed (meets design requirements) |
| Cleanliness | USP Particulate Test | Successfully completed (meets design requirements) |
| Sterility Assurance | Sterilization Validation | Successfully completed (meets design requirements) |
| Biocompatibility | Cytotoxicity | Successfully completed (meets design requirements) |
| Hemocompatibility | Successfully completed (meets design requirements) | |
| Systemic Toxicity | Successfully completed (meets design requirements) | |
| Material Mediated Pyrogenicity | Successfully completed (meets design requirements) | |
| Irritation/Intracutaneous Reactivity | Successfully completed (meets design requirements) | |
| Sensitization | Successfully completed (meets design requirements) | |
| Chemical Acceptability | Successfully completed (meets design requirements) | |
| Blood Compatibility | Thrombogenicity | Successfully completed (meets design requirements) |
| Product Protection | Packaging Integrity | Successfully completed (meets design requirements) |
| Product Lifespan | Shelf Life Verification | Successfully completed (meets design requirements) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical (bench) testing, not a clinical study involving patient data. Therefore, the concept of a "test set" in the context of human data or AI algorithms is not applicable here. The data provenance is internal to Edwards Lifesciences, derived from various laboratory and engineering tests; it is not data from human subjects or from a specific country of origin in that sense. These were likely prospective tests performed on manufactured samples of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for non-clinical engineering tests (e.g., bond strength, dimensional accuracy, sterilization) is established through standardized methodologies, engineering specifications, and validated measurement equipment, not through expert human interpretation in the way a diagnostic imaging study would use radiologists.
4. Adjudication Method for the Test Set
Not applicable. Since the tests are objective, performance is measured against established specifications or standards. There is no human interpretation or adjudication required in the sense of resolving conflicting expert opinions.
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 device is a physical medical introducer set, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical introducer set, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- Engineering Specifications: Predetermined design requirements and tolerances.
- International/National Standards: Adherence to standards like USP for particulates, ISO standards for sterilization, and specific test methods for biocompatibility (e.g., ISO 10993 series).
- Predicate Device Performance: The primary goal is to demonstrate equivalence in performance characteristics to the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set. The "training" for such a device would be its design and manufacturing process, which is refined through iterative engineering development and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The analogous process for a physical medical device involves:
- Defining design inputs and requirements based on intended use, user needs, and regulatory standards.
- Developing and manufacturing prototypes.
- Conducting iterative non-clinical testing (similar to the "Summary of Non-Clinical Testing" listed) to ensure the device meets those requirements.
- Refining the design based on test results.
Summary Takeaway:
The document is a 510(k) summary for a physical medical device (catheter introducer set). Its purpose is to demonstrate substantial equivalence to existing predicate devices through comprehensive non-clinical (bench) testing. The questions regarding AI acceptance criteria, training/test sets, expert ground truth, adjudication, and MRMC studies are not applicable to the nature of this particular device and its regulatory submission pathway. The acceptance criteria are implicitly met by "successfully completing" the listed non-clinical tests, which are designed to show that the device performs equivalently to its predicates and meets all relevant design requirements and safety standards.
§ 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).