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The 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions.

The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.

The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s).

The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.

The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented.

While the vessel is occluded, therapeutic solutions may be infused through the Proxis Catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The aspiration syringe is provided for the removal of stagnated fluid and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and removal of stagnated fluid.

The provided text describes a Special 510(k) submission for the 6F Proxis™ System. This type of submission is used when modifications to a legally marketed device do not raise new questions of safety or effectiveness. As such, the study performed is a verification study against established specifications of predicate devices, rather than a clinical trial with acceptance criteria for device performancemetrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set sample size" in the context of a clinical study. Instead, it refers to verification testing against specifications. The sample sizes for these engineering and laboratory tests (e.g., for dimensional, strength, functional properties) are not detailed in this summary, but would typically be part of the underlying design verification documentation. The data provenance is implied to be from the manufacturer's internal testing facilities, used for previous 510(k) clearances (K063638 and K052523), and is retrospective in the sense that the current submission leverages prior clearance data. No specific country of origin for the data is mentioned for these engineering tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. For this type of submission (Special 510(k) based on device modifications), clinical expert consensus for "ground truth" on patient data is not the primary basis for demonstrating safety and efficacy. Instead, the focus is on engineering and laboratory performance meeting established specifications.

4. Adjudication Method for the Test Set

Not applicable. Given that this is a Special 510(k) submission primarily relying on design verification and substantial equivalence to predicate devices, an adjudication method for a clinical test set is not described or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed to assess human reader performance, often with and without AI assistance, or comparing different diagnostic methods. This submission for the 6F Proxis™ System is for a physical medical device (catheter system) and its modifications, not a diagnostic imaging AI algorithm. Therefore, such a study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question typically pertains to AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices. The 6F Proxis™ System is a percutaneous catheter system; therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by engineering specifications and performance parameters established for the device components and system. These specifications are derived from recognized standards, clinical needs for the intended use, and the performance of previously cleared predicate devices. The "truth" is that the device meets these predetermined technical and functional requirements.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning algorithms. The 6F Proxis™ System is a physical medical device, not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device.

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