(30 days)
The Jetstream G2TM System is intended for use in atherectorny 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 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 G2TM 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.
The provided text is a 510(k) summary for the Jetstream G2™ System, a peripheral atherectomy catheter. This document focuses on demonstrating substantial equivalence to predicate devices based on identical indications for use and technological characteristics, supported by bench testing.
Therefore, the information required to populate the acceptance criteria and study details is not available in the provided text. The document does not describe a clinical study or specific performance metrics with acceptance criteria, but rather a submission for substantial equivalence based on bench testing and an identical design modification.
Here's a breakdown of why each requested section cannot be fulfilled from this document:
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A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary states that "Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k)," but it does not detail the specific performance metrics, acceptance criteria, or results of this bench testing.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document refers to "bench testing," not a clinical test set with human or animal subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth for a clinical test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an atherectomy catheter, not an AI software meant for diagnostic imaging interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for a physical procedure.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth is mentioned. The submission relies on "bench testing" to demonstrate substantial equivalence.
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The sample size for the training set: Not applicable, as no machine learning training is mentioned.
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How the ground truth for the training set was established: Not applicable.
§ 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).