(26 days)
The Jetstream G3TM 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 with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows: - Jetstream G3 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. This 510(k) is for the same device most recently cleared under 510(k) K092332, but changes the motor gear ratio to increase torque and improve cutting efficiency of the device.
The provided text is a 510(k) summary for the Jetstream G3 System. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria and the specific study that proves the device meets those criteria in the way you've outlined.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is present:
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance: This document states "Bench testing was completed and provided to support the safety and effectiveness of the modifications," but it does not present the criteria or results in a table format, nor does it quantify performance metrics.
- Sample size used for the test set and data provenance: No information on the number of cases or subjects studied, or their origin.
- Number of experts used to establish the ground truth for the test set and their qualifications: No mention of experts or ground truth establishment.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This device is an atherectomy catheter system, not an AI or imaging diagnostic device where such studies are common.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not a software algorithm in the AI sense.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable.
What the text does give us about the "study" (bench testing):
- Study Type: It was "Bench testing."
- Purpose: "Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k)." The 510(k) in question is for a modification to an already cleared device "changes the motor gear ratio to increase torque and improve cutting efficiency of the device." So, the studies were focused on verifying the impact of this specific modification.
- Conclusion: The FDA reviewed this information and determined the device is "substantially equivalent" to the predicate device. This implies the bench testing successfully demonstrated that the modified device's performance aligned with the predicate and was safe and effective for its intended use, likely through comparison to the predicate's established performance or relevant industry standards.
In summary: The provided document is a regulatory submission summary, not a detailed technical report of the studies performed. It confirms that bench testing was done to support the device modifications, but it does not provide the specific quantitative acceptance criteria or detailed results of that testing.
§ 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).