(101 days)
The PRONTO extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKY WAY OTW also may be used to subselectively infuse/deliver therapeutic agents.
The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Pronto V3 extraction catheter is a dual lumen, hydrophilically coated, rapid exchange catheter with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires that are
I am sorry, but the provided text is a 510(k) premarket notification for several medical devices (catheters) and a subsequent administrative correction letter from the FDA. It does not contain information about explicit acceptance criteria or a study that proves a device meets such criteria.
The document establishes that new versions of the Pronto V3 and LP extraction catheters, Skyway RX and OTW support catheters, and Twin-Pass dual access catheter are substantially equivalent to their predicate devices, primarily due to a hydrophilic coating modification.
The "Summary of Studies" section explicitly states:
"Pronto, Skyway and Twin-Pass catheters are substantially equivalent in intended use / indications and design to their predicate devices. Hydrophilic coating design differences have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions."
This indicates that the submission relies on bench testing (biomaterial assessments and verification testing) to demonstrate that the modified devices perform similarly to their previously cleared predicate devices, rather than a clinical study with defined acceptance criteria for a specific performance metric.
Therefore, I cannot provide the requested information, such as a table of acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or details about comparative effectiveness studies, as these are not present in the provided text.
§ 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).