(29 days)
VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.
The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.
This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end.
The VIOLA is comprised of:
- A concentric 4 mm aortic punch with a detachable handle.
- A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
- A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.
The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device called "VIOLA" and it focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data in the form of "risk analysis," "bond strength testing," and "simulated use testing" that "passed successfully all acceptance criteria," but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Details about experts for ground truth or adjudication methods.
- Information on multi-reader multi-case studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or its ground truth establishment.
The document primarily states that the modified device's technological characteristics are similar to the predicate and that performance data demonstrates it is as safe and effective.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).