(30 days)
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The VersaCross Steerable Sheath kit is a sterile, single-use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The VersaCross Steerable Sheath kit is comprised of a steerable sheath, a transseptal dilator and a J-tip guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a Pebax distal tip. The sheath has a platinum/iridium marker band positioned near the distal tip to facilitate tracking and placement of the sheath under fluoroscopy during procedures. The sheath is finished at the proximal end with a hemostatic valve and two distal side ports and has a 3-way stopcock to facilitate the injection or aspiration of fluids. The sheath is available in three curve options (i.e. small, medium, and large) that can be deflected 90° counter-clockwise and 180° clockwise. The transseptal dilator is comprised of a high density polyethylene (HDPE) tube and a stainless steel hypotube. The dilator also has a tungsten coil positioned near the distal tip to facilitate tracking and placement of the dilator under fluoroscopy during procedures. The dilator has a tapered tip and a male luer hub connector at the proximal end for connection to the sheath. The Itip guidewire is comprised of stainless steel coated with polytetrafluoroethylene (PTFE).
The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered medical device.
The document is a 510(k) premarket notification for a medical device called the "VersaCross Steerable Sheath" and "VersaCross Transseptal Dilator." This device is a catheter introducer, which is a physical medical instrument. The submission discusses the device's characteristics, its comparison to a predicate device, and various performance tests (biocompatibility, general physical, mechanical, packaging, sterilization, and bench validation).
However, it does not involve any AI or algorithmic components, and therefore, information such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not applicable to this submission.
§ 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).