(86 days)
The Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.
The Edwards eSheath Introducer Set consists of a sheath, introducer, and loader. It is provided sterile for single use and is compatible with a standard 0.035" guidewire.
The sheath shaft is comprised of a PTFE inner liner and a HDPE/TecoFlex coextruded outer layer with a folded seam that can temporarily expand if a device is passed through that is larger than the sheath's inner diameter, and a TecoFlex outer cover that encapsulates the seam. The exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a platinum/iridium radiopaque marker for visibility, and the sheath shaft mates proximally with a housing that contains an extension tube used for flushing of the sheath and three valves (seals) to provide hemostasis.
The introducer is made from polyethylene with barium sulfate for radiopacity, and features a hydrophilic coating to facilitate entry and trackability of the vessel. The introducer is tapered with an atraumatic distal tip and a lumen to accommodate a 0.035" guidewire.
The loader may be used to aid in the insertion of devices into the sheath and may be removed so that the entire working length of the inserted device can be utilized. The loader housing contains a valve (seal) to provide hemostasis.
This document is a 510(k) summary for the Edwards eSheath Introducer Set. It outlines the device's description, intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain the specific details required to answer all the questions regarding acceptance criteria and a detailed study report. The document describes several tests performed, but it lacks specific acceptance criteria values and detailed study methodologies, sample sizes, and ground truth information for each test.
Here's an attempt to extract and format the available information, noting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed to demonstrate performance. However, specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this 510(k) summary. The summary only states that these tests were "successfully completed" or that "performance testing has demonstrated that safety and efficacy are not adversely impacted."
| Acceptance Criteria (e.g., specific quantitative limits or qualitative outcomes) | Reported Device Performance (e.g., measured values, pass/fail status) |
|---|---|
| Visual Surface Inspection: (Not specified) | Successfully completed. |
| Dimensional Inspection: (Not specified) | Successfully completed. |
| Radiopacity/Visualization: (Not specified) | Successfully completed. |
| Guidewire Compatibility: (Not specified) | Successfully completed. |
| Hemostasis: (Not specified) | Successfully completed. |
| Kink Resistance: (Not specified) | Successfully completed. |
| Seam Return After Expansion: (Not specified) | Successfully completed. |
| Bond Strength: (Not specified) | Successfully completed. |
| Loader Peel Test: (Not specified) | Successfully completed. |
| Device Interaction: (Compatibility with Edwards SAPIEN XT Transcatheter Heart Valve and NovaFlex+ delivery system) | Compatibility testing completed using specified devices. |
| Hydrophilic Coating Integrity: (Not specified) | Successfully completed. |
| USP Particulate Test: (Not specified) | Successfully completed. |
| Sterilization Validation: (Not specified) | Successfully completed. |
| Biocompatibility Tests: (Cytotoxicity, Hemocompatibility, Systemic Toxicity, Material Mediated Pyrogenicity, Irritation/Intracutaneous Reactivity, Sensitization, Chemical Acceptability, Thrombogenicity) | Successfully completed. |
| Packaging Integrity: (Not specified) | Successfully completed. |
| Shelf Life Verification: (Not specified) | Successfully completed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for any of the listed non-clinical tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (laboratory/bench) tests for a new device, they are inherently prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the document describes non-clinical, bench testing of a medical device, not a study involving human-in-the-loop performance or expert interpretation of diagnostic data to establish ground truth.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described in this document. The listed tests are non-clinical evaluations of the device's physical and functional properties, not a comparison of human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This section is not applicable. The device is a physical medical introducer set, not an algorithm or AI system. The tests described are for the physical device's performance.
7. Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" would be established by:
- Engineering Specifications/Design Requirements: For tests like dimensional inspection, bond strength, kink resistance, etc., the ground truth is defined by pre-established engineering tolerances and performance specifications.
- Industry Standards (e.g., ISO, ASTM, USP): For tests like USP Particulate Test, Biocompatibility (following ISO 10993 series), Sterilization Validation, these standards define the methods and acceptance criteria that serve as the ground truth.
- Functional Demonstrations: For compatibility and hemostasis, the ground truth is successful operation and absence of leaks/issues under simulated use conditions.
The document does not explicitly state these ground truth sources for each test but implies their use through the nature of the tests.
8. Sample Size for the Training Set
This section is not applicable as the document describes non-clinical testing of a physical medical device, not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above.
§ 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).