(140 days)
The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.
The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied quidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip.
The provided text is a 510(k) premarket notification for the Rotarex™ Atherectomy System. This document explicitly states that no changes have been made to the subject Rotarex™ Atherectomy System itself. The purpose of this submission is to obtain FDA clearance related to proposed revisions to the existing Rotarex™ Atherectomy System instructions for use (IFU) to clarify and emphasize procedural steps to reduce the risk of catheter breakage events.
Given this, the document clearly states:
"As no changes are being made to the Rotarex™ Atherectomy System associated with this 510(k) notice, no new performance testing was conducted on the subject device."
Therefore, the Acceptance Criteria and Device Performance information you requested, related to new testing proving the device meets acceptance criteria, cannot be extracted from this document because such testing was not performed for this specific 510(k) submission.
This document describes a regulatory filing for an IFU update for an already cleared and existing device. It does not contain information about the original performance data, acceptance criteria, or studies used to clear the initial device.
In summary, none of the requested information (performance table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be provided based on the text you supplied, as the document explicitly states no new performance testing was conducted.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).