(59 days)
The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature
The Jetstream™ Pathway PVTM Atherectorny System (hereafter "Jetstream 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 Excised tissue, thrombus, and fluid are aspirated from the peripheral device use 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 Jetstream System consists of two primary components (1) a Jetstream Catheter and Control Pod and (2) a PV Console, which are packaged separately Each of these system components is described generally as follows
- Jetstream Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven Jetstream 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 PV 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
Here's an analysis of the provided text regarding the Jetstream™ Pathway PVT™ Atherectomy System, focusing on acceptance criteria and study information.
It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview to demonstrate substantial equivalence to a predicate device. It doesn't usually contain the detailed study protocols, raw data, or comprehensive statistical analysis found in a full clinical trial report.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on bench testing to support the expanded indications for use and demonstrates substantial equivalence to predicate devices.
The key reported performance is the "expanded indications for use," which now includes the ability "to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter." The implicit acceptance criterion is that the device is safe and effective for this expanded indication, as demonstrated through bench testing and comparison to predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and effectiveness | "Bench testing was completed and information provided to support the safety and effectiveness of the expanded indications for use for the Jetstream System." |
| Expanded Indication for Use | System is intended "to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a clinical test set sample size or clinical data provenance (e.g., country of origin, retrospective/prospective). The evidence provided is based on "bench testing." Bench testing typically involves laboratory experiments on models or excised tissue, not human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the study described is "bench testing" rather than a clinical study evaluating diagnostic accuracy or expert interpretation, the concept of "ground truth for a test set" established by experts does not apply in the traditional sense. Bench testing would likely involve engineers and technicians evaluating mechanical performance, material properties, and the device's ability to perform its intended function in a controlled environment.
4. Adjudication Method for the Test Set
As there's no clinical test set with human interpretation, an adjudication method for test set ground truth is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned or implied. The study described is bench testing, not a clinical study involving human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
This device is an atherectomy system, a physical medical device. It is not an algorithm or AI system, so the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
For the "bench testing" mentioned, the "ground truth" would be established by controlled experimental conditions and measurements. For example, if testing the ability to remove thrombus, the "ground truth" would be the known amount of simulated thrombus placed in a model, and the performance would be measured by the amount removed. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is a physical device, not an AI/ML model, the concept of establishing ground truth for a "training set" is not applicable.
Summary of Findings from the 510(k) Summary:
The 510(k) summary for the Jetstream™ Pathway PVT™ Atherectomy System primarily relies on demonstrating substantial equivalence to predicate devices and provides evidence through bench testing to support its expanded indications for use. It does not contain information about clinical studies involving human subjects, reader performance, or AI/ML model evaluation. Therefore, many of the requested details regarding sample sizes, expert ground truth, and training data are not present in this type of regulatory document for this category of device.
§ 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).