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The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the 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 solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

The Proxis Flow-Control device is a dual balloon catheter. It has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter System, and an Evacuation syringe.

The Evacuation Sheath also has two low-pressure compliant balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has an inner diameter of 0.058 inches and can accommodate standard therapeutic devices that have profiles of 0.058 inches or lower. The balloons are inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the Proxis balloons are inflated, and the vessel occluded. Infusing less than 0.5cc of contrast dye through the guide catheter will produce a "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, less than 0.5cc of therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device while the vessel is occluded.

The Evacuation syringe is provided in the event that removal of contrast, or therapeutic solution is desired. If distal perfusion of fluid is needed during evacuation, the Infusion Catheter System may be used.

Here's an analysis of the provided text regarding the Proxis Flow-Control Device, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document provides very high-level summaries of performance. Specific numerical acceptance criteria (e.g., "tensile strength greater than X N") and their corresponding measured values are not detailed in this 510(k) summary. The statement "device meets or exceeds the requirements of these standards" implies that the specific criteria outlined within each standard were successfully met.

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

• Sample Size:
  • Animal Studies: Nine acute animals and eight chronic animals. This constitutes the primary "test set" for in-vivo performance and safety.
  • Bench Testing: The sample sizes for dimensional verification, balloon compliance, tensile strength, torque strength, flexibility, and trackability are not specified in this summary. It simply states "performance testing included..."
• Data Provenance: The document does not explicitly state the country of origin for the animal studies. It is likely that these studies were conducted in the country where Velocimed Inc. is based (Minneapolis, MN, USA) or in a country with established regulatory frameworks for medical device animal testing. The animal studies are prospective in nature, as they were conducted to validate the device's performance and safety before market clearance.

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

This type of information is not applicable or not provided for this 510(k) summary. For a device like the Proxis Flow-Control Device, the "ground truth" during performance and safety testing is established through objective measurements (e.g., physical dimensions, strength tests, biocompatibility assays) and observation of physiological responses in animal models by veterinarians and researchers, rather than expert consensus on interpretive data (like radiology images).

4. Adjudication Method (for the test set)

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where there is subjective interpretation of data that needs consensus or tie-breaking by experts. For the type of performance and animal testing described here, the results are generally objective and measured, or observed directly by the testing personnel.

5. 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

There is no MRMC comparative effectiveness study mentioned in this document. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers and their performance with or without AI assistance.

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

This information is not applicable or not provided. This device is a physical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm on its own, without human interaction.

7. The Type of Ground Truth Used

• Bench Testing: Objective physical measurements, adherence to engineering specifications, and compliance with international standards (ISO, ASTM).
• Animal Studies: Direct observation of physiological effects, safety assessments (e.g., lack of adverse tissue reactions, proper functioning within the vasculature), and performance characteristics (e.g., successful occlusion, delivery capability). The "ground truth" here is the biological and mechanical reality observed in the animal model.

8. The Sample Size for the Training Set

There is no "training set" mentioned or implied. This device is a physical medical device. The concept of a "training set" is primarily relevant to machine learning or AI algorithms, where data is used to train a model. For medical devices like this catheter, internal product specifications and engineering designs guide its development, and then independent testing (bench and animal) is conducted for validation.

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

As there is no "training set" for this physical device, this question is not applicable.

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