(44 days)
The Kerberos Proximal Solutions Rinspiration Catheter System is intended to infuse physician specified fluid and remove/aspirate fresh, soft emboli and thrombi from the coronary and peripheral vasculature.
The system consists of a Rinspiration® Catheter, and a Rinspirator® with accessories. The Rinspiration Catheter is a multi-lumen, rail configuration catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration Catheter will be placed in the vasculature of a patient over a quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration®."
The only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines.
The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids.
In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.
I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The documents are FDA 510(k) letters and summaries for a device called the "Rinspiration System," which focus on its substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).