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The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters 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.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is 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. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

This document describes the validation of the 091 Balloon Guide Catheter. Since the provided text focuses on the device's substantial equivalence to a predicate device for regulatory approval, the "acceptance criteria" and "device performance" primarily refer to engineering performance specifications and bench testing results, rather than clinical efficacy metrics for an AI/ML device. There is no mention of an AI/ML component in this premarket notification.

Therefore, the requested information specifically related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance) is not applicable to this document. The document details the testing performed to ensure the device meets safety and performance standards for a medical device.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test. The reported device performance is that it met all predetermined acceptance criteria for each test.

Details of the Study:

• 1. A table of acceptance criteria and the reported device performance: Provided above. All tests "Passed," indicating the device met all predetermined acceptance criteria.

• 2. Sample size used for the test set and the data provenance: The document states that "Some of the tests were also conducted on the predicate device to help establish substantial equivalence." However, specific sample sizes for each test are not explicitly detailed in this summary. The data provenance is from bench testing and simulated use, conducted to support a regulatory submission in the United States. It is not patient data, so "retrospective or prospective" is not applicable.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of an AI/ML device. For the "In-vitro Simulated Use Study – Benchtop," it states "A simulated interventional procedure was performed by physicians." For "Usability Testing," it mentions "Evaluators representative of the intended user population shall review... then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models." The specific number or qualifications of these physicians/evaluators are not detailed.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device with image interpretation or complex diagnostic outputs requiring expert adjudication. Performance was assessed against pre-defined engineering and functional criteria.

• 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: Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.

• 7. The type of ground truth used:

  • Engineering/Performance Specifications: For most tests (e.g., Tensile Strength, Torque Strength, Burst, Leak tests, Dimensional Verification), the "ground truth" is defined by established engineering and materials standards (e.g., ISO 10555-1, USP <788>, ASTM F-1929, ISO 594-1:1986).
  • Simulated Use/Usability: For these tests, the "ground truth" is the successful and safe performance of the device by intended users in a simulated clinical environment, meeting pre-defined operational criteria.
  • Biocompatibility: The "ground truth" is compliance with ISO 10993-1 and specific biological test methodologies (e.g., MEM elution, Magnusson-Kligman Method, ASTM Method for Hemolysis) to ensure the device is not harmful to biological systems.

• 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML device trained on data.

• 9. How the ground truth for the training set was established: Not applicable.

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