(24 days)
The Pathway PVTM Atherectomy 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 Pathway PV Atherectomy 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 ports 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 Pathway PV Atherectorny 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:
- 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.
- A reusable compact Console, with two (2) peristaltic pumps for . Console: 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 the Console to add a check of the Control Pod's parameter settings at the time of device use.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary (K082664) for the Jetstream™ Pathway PVT™ Atherectomy System does not contain explicit acceptance criteria or details of a study proving the device meets specific performance criteria in the way you might expect for an AI/algorithm-based device.
Instead, this 510(k) is for a modification to an existing, already cleared device (K081328, K082186). The primary claim for this submission is substantial equivalence to the predicate device.
The document states:
- "This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use."
- "The Pathway PV Atherectomy System is substantially equivalent to the specified predicate device. The device has the identical indications for use and the same technological characteristics. Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System."
This indicates that the "study" was focused on demonstrating the safety and effectiveness of the modification (the Console's parameter check) through bench testing, rather than a full-scale clinical performance study with predefined acceptance criteria for a new device.
Therefore, for many of your requested points, the answer is that the information is not applicable or not provided in this type of 510(k) submission, which focuses on substantial equivalence for a physical device modification.
Detailed Breakdown of Requested Information:
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A table of acceptance criteria and the reported device performance
- Not provided. The document does not list quantitative acceptance criteria or specific performance metrics. The "performance" demonstrated was that the modified console's parameter check maintained the safety and effectiveness established by the predicate device through 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 / Not provided. Since the study involved bench testing for a physical modification, there isn't a "test set" of patient data in the typical sense for algorithms.
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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 / Not provided. Ground truth, in the context of expert review of images or clinical outcomes, is not relevant for this type of bench testing study for a physical device modification.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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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
- No. This device is a physical atherectomy system, not an AI/algorithm for image analysis or diagnosis. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For the bench testing mentioned, "ground truth" would likely relate to engineering specifications, mechanical performance, or functional checks, rather than clinical ground truth types. The document only states "Bench testing was completed and provided to support the safety and effectiveness of the modifications."
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The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).