(30 days)
The iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.
The iSLEEVE Expandable Introducer Set (iSLEEVE Introducer Set) is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock.
The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the working end of the iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.
A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.
The provided text is related to a 510(k) premarket notification for a medical device called the "iSLEEVE Introducer Set." It describes the device, its intended use, and the regulatory process. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device and mentions general categories of non-clinical performance data.
Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.
The text does state:
"Testing demonstrated that the modified iSLEEVE Introducer Set met the previously established acceptance criteria."
And lists the types of non-clinical testing performed:
- Luer Connections
- Simulated Use Testing
- Dimensional Requirements
- Tensile Testing
- Packaging Testing
- Radiopacity
- Sterilization
- Usability
However, it does not provide the specific acceptance criteria values or the reported performance data against those criteria. It also doesn't contain the detailed study design elements you asked for, such as the number of experts, adjudication methods, or specific study types.
§ 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).