(29 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 two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath 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. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.
Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen.
The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.
This document describes the Edwards eSheath Introducer Set, a medical device used for introducing and removing other devices in the vascular system, specifically with the Edwards SAPIEN 3 Transcatheter Heart Valve. The document is a 510(k) premarket notification summary submitted to the FDA, asserting substantial equivalence to a previously cleared device. Due to the nature of the device (a catheter introducer) and the provided document, the "acceptance criteria" and "study" are related to mechanical and material performance, not an AI/ML-based diagnostic or prognostic study. Therefore, many of the requested fields are not applicable in this context.
Here's the information extracted and interpreted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance |
|---|---|
| Functional / Mechanical Performance: | |
| Loader Peel Test | Successfully completed (demonstrated satisfactory performance) |
| Bond Strength Test | Successfully completed (demonstrated satisfactory performance) |
| Biocompatibility: | |
| Cytotoxicity | Successfully completed (demonstrated satisfactory performance) |
| Sensitization | Successfully completed (demonstrated satisfactory performance) |
| Irritation/Intracutaneous Toxicity | Successfully completed (demonstrated satisfactory performance) |
| Systemic Toxicity | Successfully completed (demonstrated satisfactory performance) |
| Hemocompatibility | Successfully completed (demonstrated satisfactory performance) |
| Material Verification | Successfully completed (demonstrated satisfactory performance) |
| USP Physico-Chemical Test for Plastic Closures | Successfully completed (demonstrated satisfactory performance) |
| Other Performance: | |
| Sterilization Validation | Successfully completed (demonstrated satisfactory performance) |
| Packaging Integrity | Successfully completed (demonstrated satisfactory performance) |
| Shelf Life Verification | Successfully completed (demonstrated satisfactory performance) |
| Overall Equivalence | Based on device testing and descriptive characteristics, the device is substantially equivalent to the predicate device and has demonstrated to not adversely impact safety and efficacy. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of units tested for each test. The document states "Non-clinical testing was completed" and "design verification and validation testing was successfully completed."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would generally be conducted in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a catheter introducer, not a diagnostic or AI/ML device requiring expert ground truth for classification. The "ground truth" here is the physical and biological performance adhering to established standards.
4. Adjudication method for the test set
- Not applicable for this type of device and testing. Performance standards are objective measurements, not subjective evaluations requiring adjudication.
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 not an AI/ML device, and no human reader study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- The "ground truth" for this device's testing is adherence to established engineering, material science, and biocompatibility standards and specifications. This includes:
- Objective measurements: Force, strength, dimensional accuracy, flow rates, etc., for functional tests like "Loader Peel Test" and "Bond Strength Test."
- Standardized biological assays: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).
- Validated protocols: For sterilization, packaging integrity, and shelf-life verification.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for the device's design would be through iterative engineering development and testing.
9. How the ground truth for the training set was established
- Not applicable. For a physical device, the "ground truth" for design and manufacturing is established through engineering specifications, material properties, and adherence to relevant industry and regulatory 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).