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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of 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 Modified Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, 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. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

This document describes a 510(k) submission for a Modified Balloon Guide Catheter (K122581) which claims substantial equivalence to a predicate device (K112404). This is a medical device submission, not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device evaluation frameworks (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

The evaluation of this catheter focuses on its mechanical, functional, and biocompatibility performance to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of verification and validation (V&V) tests performed on the Modified Balloon Guide Catheter and its accessories. These tests were conducted by Concentric Medical, Inc. (the submitter). The summary states that "The results of verification and validation conducted on the Modified Balloon Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."

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

• Sample Size for Test Set: This information is not provided in the given text. For medical device V&V testing, sample sizes are typically determined based on statistical rationale for each specific test (e.g., number of units tested for tensile strength, number of balloons for burst pressure). The general statement "successfully evaluated" implies that sufficient units were tested to meet the predetermined acceptance criteria.
• Data Provenance: The data originates from internal testing conducted by Concentric Medical, Inc., for their 510(k) submission to the FDA. The nature of these tests (e.g., mechanical, functional, biocompatibility) implies they are prospective in relation to the submission, as they were specifically carried out to support the device's clearance. Country of origin of data is implicitly the USA, where the company is based, although the specific test labs are not detailed.

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

This question is not applicable as there is no "ground truth" in the context of expert review for diagnostic imaging or similar AI/ML applications. The "truth" for this physical device is established by objective, measurable engineering and biological test standards and protocols. For example, for tensile testing, the "ground truth" is a certain force in Newtons, not a diagnostic interpretation by an expert.

4. Adjudication Method for the Test Set

This question is not applicable as there is no need for expert adjudication in the context of physical medical device performance testing as described. The tests have objective pass/fail 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

This question is not applicable. This is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

This question is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

• Engineering Specifications: Predetermined performance targets and specifications (e.g., maximum deflection force, torque transmission ratio, peel strength values).
• Established Test Standards: Compliance with recognized international or national standards for medical device testing (e.g., ISO standards for biocompatibility).
• Predicate Device Performance: Performance data from the legally marketed predicate device (K112404) often serves as a benchmark for substantial equivalence, implying that the modified device must perform at least as well as the predicate for critical characteristics.
• Biological/Chemical Standards: For biocompatibility, established thresholds for toxicity, sensitization, hemolysis, etc. are the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device; there is no "training set" in the context of AI/ML model development.

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

This question is not applicable for the same reason as above.

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