(21 days)
The Jetstream G2™ System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
The Jetstream G2TM 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 atherectorny procedure.
The Jetstream G27M System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- . Jetstream G2TM Catheter and 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.
This 510(k) is for the same device with modifications to change the location of the distal tip aspiration ports to a single aspiration port located just proximal to the differentially cutting tip.
The provided document, K083837, is a 510(k) premarket notification for the Jetstream G2™ System. This document describes the device and its intended use, but it does not contain details about acceptance criteria, a clinical study, or performance data beyond bench testing.
The most relevant section states: "Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k)." This indicates that the approval was based on bench testing demonstrating that modifications to the aspiration ports did not negatively impact the device's safety and effectiveness compared to its predicate device (Jetstream™ Pathway PV™ Atherectomy System, K082664).
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and bench testing, rather than presenting a study with specific acceptance criteria and detailed performance metrics against those criteria.
Please note that for a 510(k) submission, especially for a modification to an existing device, a full-scale clinical study with the kind of details requested (sample size, ground truth, expert adjudication, MRMC studies) is often not required if substantial equivalence can be demonstrated through other means like bench testing and comparison to a legally marketed predicate device.
§ 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).