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Flow Gate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Like the predicate device, the 8F FlowGate2™ Balloon Guide Catheter is a coaxial- lumen, braidreinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

The provided text describes a 510(k) premarket notification for the 8F FlowGate2™ Balloon Guide Catheter. It outlines the acceptance criteria and testing performed to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that all performed tests "Met established acceptance criteria." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a list of tests and a blanket statement of compliance.

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

The document does not specify the sample sizes (number of devices or cases) used for the verification and validation (test set) activities. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench testing performed on manufactured devices.

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

This information is not provided in the document. The study described is a technical verification and validation of a medical device's physical and functional properties, not a clinical study involving human assessment of data requiring expert ground truth establishment in the typical sense (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective technical assessments (e.g., measuring leak resistance, tensile strength, kink resistance), not subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not a diagnostic or AI-assisted interpretation device that would typically involve human readers. The study focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through material, design, and performance testing.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device (catheter). The testing focuses on the physical and functional performance of the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is based on established engineering principles, industry standards (e.g., ISO 11135, EN ISO 10993-1), and internal performance specifications determined through design and risk assessment processes. For instance, for "High Pressure Leak," the ground truth is a pass/fail criterion based on whether the device exhibits leakage under specific pressure. These are objective measures rather than subjective expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning device that requires a training set.

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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