(30 days)
The Jetstream G3™ 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 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 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 G3 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 most recently cleared under 510(k) K091509, but changes the distal cutter design to improve cutting efficiency and manufacturability of the device.
The provided text describes a 510(k) summary for the Jetstream G3™ System, a peripheral atherectomy catheter. However, it does not contain information about acceptance criteria, device performance metrics, or a study that specifically proves the device meets acceptance criteria in the context of AI/ML or diagnostic performance.
The document discusses:
- General Information: Manufacturer, contact, trade/common name, regulation, product code, predicate devices.
- Indications for Use: What the device is intended for (atherectomy of peripheral vasculature, thrombus removal from upper and lower extremity peripheral arteries ≥3.0 mm in diameter) and what it is not intended for (coronary, carotid, iliac, or renal vasculature).
- Device Description: Components (Catheter and Control Pod, Console), how it works (expandable cutting tip, aspiration, infusion).
- Substantial Equivalence: It states that this 510(k) is for the same device cleared previously (K091509) but with changes to the distal cutter design to improve cutting efficiency and manufacturability. It claims substantial equivalence to predicate devices, identical indications for use, and same technological characteristics.
- Bench Testing: It mentions "Bench testing was completed and provided to support the safety and effectiveness of the modifications." This implies that the bench testing results supported the claim of improved cutting efficiency and manufacturability, but it does not specify what the acceptance criteria for this bench testing were, nor does it provide any quantitative performance data from this testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not applicable as no specific "test set" for performance evaluation in the requested context is mentioned.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document is a regulatory submission for a medical device (atherectomy catheter) and focuses on demonstrating substantial equivalence to previously cleared devices based on design and technical characteristics, supported by bench testing regarding mechanical efficiency and manufacturability. It is not an AI/ML or diagnostic device submission that would typically include the requested performance metrics and study details.
§ 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).