(87 days)
The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.
The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature.
The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. 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 to provide hemostasis, and an extension tube with stopcock for flushing.
The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.
The loader (included in the Edwards delivery system) 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.
The provided document is an FDA 510(k) clearance letter and summary for the Edwards eSheath Optima introducer set. It demonstrates substantial equivalence to a predicate device based on non-clinical testing. However, it does not contain a detailed study meeting the specific criteria you've outlined, particularly for AI/algorithm performance. The information provided relates to the physical and functional performance of a medical device, not an AI or software component.
Therefore, I cannot extract the following information from the provided text:
- 1. A table of acceptance criteria and the reported device performance: While the document mentions various bench tests were "successfully completed" and "all design requirements were met," it does not provide specific quantitative acceptance criteria or detailed numerical results for each test.
- 2. Sample sized used for the test set and the data provenance: Not applicable, as this is non-clinical bench testing of a physical device, not an AI or software study with a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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, as this device does not involve AI or human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable in the context of AI/software performance. For a physical device, the "ground truth" would be the engineering specifications and established test methods.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of available information from the document:
The document describes the Edwards eSheath Optima introducer set, a physical medical device.
Device Description:
The introducer set comprises a sheath, vessel dilator, introducer, and in-sheath dilator. It's designed to facilitate the introduction and removal of compatible devices used with Edwards transcatheter heart valves. Key features include an expandable inner member and outer jacket, a radiopaque marker, a hydrophilic coating, hemostatic seals, and an optional in-sheath dilator.
Non-Clinical Testing:
A list of bench tests was performed to demonstrate substantial equivalence to the predicate device and that all design requirements were met. These tests cover various physical and functional aspects of the device, including:
- Recovered Outer Diameter (OD)
- In-Sheath Dilator (ISD) Max Distal OD
- Tip OD
- ISD Insertion & Retrieval
- Tip Inner Diameter (ID)
- Sheath Insertion & Retrieval
- Sheath Working Length
- ISD Working Length
- Hemostasis
- Kink Radius
- Fishmouth
- Lubricity and Durability
- Bond Tensile Strengths (Sheath Housing to Shaft, Sheath Shaft to Tip, Flush Tube to Housing, Stopcock to Flush Tub, ISD Hub to Shaft)
- Transcatheter Heart Valve (THV)/Sheath Interaction
- Device Interaction
- Guidewire Compatibility
- Delivery System Insertion & Retrieval
- Crimped THV Retrieval
- Radiopacity
- Particulate Testing
- Sterilization Validation
- Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity)
The document states that these tests were "successfully completed" and that "all design requirements were met," leading to the conclusion that the device is substantially equivalent to the predicate. However, it does not provide specific acceptance criteria values or the quantitative results from these tests.
§ 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).