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The Concentric Balloon Guide Catheter is indicated for use in facilitating 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 Concentric Balloon Guide Catheter device, cleared under K010954, is a 9F coaxial lumen braided shaft, variable stiffness catheter with a radiopaque marker on the distal end. The balloon is flush mounted on the distal end of the catheter. The inner diameter of the balloon guide catheter is 0.085". The maximum inflation diameter is 10 mm, and the maximum inflation length is 10 mm.

The design of the modified Concentric Balloon Guide Catheter differs in dimension and includes a new material, Cristamid. All other characteristics remain the same as compared to the original device. The outer and inner diameters have been downsized to 7F and 0.059" respectively. Biocompatibility of Cristamid has been established and results provided in the Concentric HD Guide Catheter Premarket Notification (K003880).

The Concentric Balloon Guide Catheter (7F) is being submitted for a Special 510(k) Premarket Notification. The device is a modified version of the previously cleared Concentric Balloon Guide Catheter (9F, K010954). The primary modifications include a reduction in outer and inner diameters (7F and 0.059" respectively) and the introduction of a new material, Cristamid.

The submission focuses on establishing substantial equivalence to the predicate device (Concentric 9F Balloon Guide Catheter, K010954) rather than demonstrating performance against specific qualitative acceptance criteria. Therefore, the information provided does not contain a typical table of acceptance criteria and reported device performance in the manner usually associated with a new device's performance claims (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be interpreted as the requirement to demonstrate substantial equivalence through performance testing, and the "study" is this performance testing itself.

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) based on substantial equivalence to a predicate device, specific quantitative acceptance criteria for clinical performance (like sensitivity or specificity) are not provided in the document. The "acceptance criteria" here is that the modified device performs "as designed" and is "suitable for its intended use" when compared to the predicate through performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states "Performance testing has been conducted," but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). This typically refers to bench testing rather than clinical data for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. For a medical device like a catheter, "ground truth" as it relates to expert review of diagnostic output is not relevant. The "ground truth" for this device would be its mechanical and material properties meeting engineering specifications and its functional performance in a simulated environment replicating its intended use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or image review settings to establish a consensus ground truth, which is not relevant for the type of performance testing indicated for this device.

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 information is not applicable and not provided. The device is a physical medical instrument (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant.

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

This information is not applicable and not provided. The device is a physical medical instrument and does not involve an algorithm operating in a standalone mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device modification would be based on:

• Engineering specifications and test standards: The device's physical dimensions, material properties (e.g., biocompatibility of Cristamid as established in K003880), mechanical strength, inflation characteristics, and guidability would be tested against established engineering parameters and predicate device performance.
• Functional performance: Testing would likely involve bench models simulating vascular systems to evaluate aspects like ease of guidance, occlusion capabilities, and catheter navigation.

The document states "Performance testing has been conducted and the results of the testing verified that the Concentric Balloon Guide Catheter performs as designed and is suitable for its intended use." This implies the ground truth was based on these types of objective engineering and functional evaluations.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical instrument, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As the device is not an AI/ML model, there is no training set for which ground truth would be established.

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