(26 days)
14F iSLEEVE Introducer Set:
The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm diameter.
15F iSLEEVE Introducer Set:
The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.
The iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of compatible transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway 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 entire 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.
This document is a 510(k) Pre-Market Notification from the FDA regarding the Boston Scientific Corporation's iSLEEVE™ Introducer Set. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the context of AI.
The document discusses medical devices classified as "Catheter Introducer," which are physical tools used to facilitate access to the vascular system. The review is based on "non-clinical performance bench testing data," not on computational analysis or AI model performance.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device. The input document pertains to a traditional medical device (a catheter introducer) and its regulatory clearance based on substantial equivalence to a predicate device, not an AI/ML device.
§ 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).