(30 days)
The Jetstream G3TM L System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥ 3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.
The Jetstream G3 L System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. The Jetstream G3 L System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows: Jetstream G3 L Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray. PV Console: A reusable compact Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I. V. stand and remains outside the sterile field during the procedure.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Jetstream G3TM L System peripheral atherectomy catheter) and focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.
Therefore, I cannot provide the requested information.
§ 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).