(264 days)
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.
The provided document is a 510(k) premarket notification for a medical device called the EZE SIT Valvulotome. It asserts substantial equivalence to a predicate device (Tru-Incise Valvulotome K930011).
Crucially, this document states that no performance data, including clinical studies or data demonstrating adherence to acceptance criteria for an AI/algorithm-driven device, were required or provided. The submission is intended "to simply indicate a new manufacturer for a currently cleared device design that has not changed since its clearance (K930011)."
Therefore, the acceptance criteria and study proving the device meets those criteria, as requested in the prompt, are not present in this document. This device does not have software components and is not an in vitro diagnostic device, and thus the type of AI/algorithm performance study envisioned by the prompt is not applicable to this submission.
The document only includes:
- Nonclinical data: Sterilization, Shelf Life/Aging, and Biocompatibility, all of which confirmed substantial equivalence to the predicate device.
- Sterilization: Validated with half-cycle using ISO 11135-1: 2014, achieving a Sterility Assurance Level (SAL) of 10-6. Residuals measured: 0.6 mg EtO,
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).