(123 days)
Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.
The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.
The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The sidetube extension is used for site management.
The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.
Super Sheaths can be ordered with a Polypropylene suture wing color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures.
The uncoated mini guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The mini guidewire (with Inserter) is available in 45cm and 80cm lengths. The Inserter does not contact blood and is used strictly for guiding the guidewire into a cannula or introducer. A US commercially available mini guidewire (meeting Medikit specifications) may be used in the sets or the mini guidewire that is described in this submission.
This is a medical device submission for a "Super Sheath Introducer Sheath" which is a physical device, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and study details for an AI/ML device are not applicable to this document. The document describes functional testing of the physical device to demonstrate substantial equivalence to a predicate device, as opposed to performance metrics for an AI/ML algorithm.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).