(28 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 Atherectomy System consists of two primary components: (I) a Catheter and Control Pod and (2) a Console, which are packaged separately.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information:
Analysis of Acceptance Criteria and Study Information for Pathway PV Atherectomy System (K082186)
The provided 510(k) summary for the Pathway PV Atherectomy System (K082186) focuses on demonstrating substantial equivalence to a predicate device after modifications to improve manufacturability, ergonomics, and ease of use. It explicitly states that the device has "identical indications for use and the same technological characteristics" as its predicate.
Crucially, this 510(k) summary does not detail specific acceptance criteria for performance, nor does it describe a clinical study or a standalone algorithm performance study with a test set, ground truth, or expert involvement. The documentation primarily relies on bench and laboratory testing to support the safety and effectiveness of the modifications to the device.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document.
The document states: "Bench and laboratory 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." However, it does not specify what parameters were tested, what the acceptance criteria for those tests were, or the quantitative results of those tests. These details would typically be found in the comprehensive testing reports submitted to the FDA, but they are not part of this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not available concerning clinical data or a test set for performance assessment.
The "bench and laboratory testing" mentioned would have involved a certain number of test units or trials, but the sample sizes for these engineering tests are not disclosed. There is no mention of a clinical "test set" in terms of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/available.
Since there is no described clinical "test set" and no ground truth establishment process involving expert review for performance, this information is not provided. The 510(k) pathway for this device focused on demonstrating equivalence through engineering modifications, not on a new clinical efficacy study.
4. Adjudication Method for the Test Set
Not applicable/available.
No test set for performance requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic imaging AI devices, comparing human performance with and without AI assistance. The Pathway PV Atherectomy System is a mechanical atherectomy device, not a diagnostic AI system, so an MRMC study would not be applicable or expected.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done.
The device is an electromechanical system for atherectomy, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
Not applicable/available.
Without a clinical or diagnostic performance study described, there is no mention of ground truth types (e.g., pathology, outcomes data, expert consensus). The "ground truth" for the engineering changes would have been the established performance specifications of the predicate device and relevant industry standards.
8. The Sample Size for the Training Set
Not applicable/available.
The device is not an AI/ML system that utilizes a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available.
As the device is not an AI/ML system, there is no training set or associated ground truth establishment process.
Summary Limitations:
The provided 510(k) summary is typical for a device with minor modifications where substantial equivalence is demonstrated primarily through engineering verification and validation (bench and lab testing) rather than new clinical trials. It confirms that the modifications did not alter the safety, effectiveness, or indications for use compared to the predicate device. Therefore, the detailed information requested about clinical acceptance criteria, expert reviews, and AI-specific study designs is not within the scope of this particular document.
§ 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).