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The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.

The balloon provides temporary vascular occlusion during these procedures.

The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.

The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label.

The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section.

The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.

The provided text is a 510(k) clearance letter for a medical device, the Branchor X Balloon Guide Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or safety through large-scale clinical trials.

As such, the document details non-clinical bench testing and biocompatibility testing to show that the new device performs comparably to the predicate and meets established safety standards. It explicitly states that "Animal study was not deemed necessary to demonstrate substantial equivalence" and "Clinical study was not deemed necessary to demonstrate substantial equivalence."

Therefore, the information regarding acceptance criteria and the "study that proves the device meets the acceptance criteria" will be focused on these non-clinical tests. There is no information about human-in-the-loop studies (MRMC), standalone AI performance, ground truth establishment for a training set (as there's no AI component mentioned), or expert adjudication, simply because these types of studies were not required for this particular 510(k) submission.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance Study for Branchor X Balloon Guide Catheter

The device, Branchor X Balloon Guide Catheter, demonstrates substantial equivalence to its predicate device, the Branchor Balloon Guide Catheter (K221951), through extensive non-clinical bench testing and biocompatibility assessment. The aim of these studies was to confirm that the new device met pre-established acceptance criteria, functioned as intended, and had a safety and effectiveness profile similar to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were "All samples met the acceptance criteria," indicating a 100% success rate for the tested samples against predefined engineering and safety specifications.

Biocompatibility Testing:

2. Sample Size and Data Provenance

• Sample Size: The document repeatedly states "All samples met the acceptance criteria" for non-clinical tests. However, the exact numerical sample size for each specific test (e.g., how many catheters were tested for burst pressure) is not specified in this 510(k) summary.
• Data Provenance: The device manufacturer is ASAHI INTECC CO., LTD., located in Japan, with a US presence. The testing is non-clinical bench testing and refers to ISO standards. The data is not from human patients and therefore does not have a country of origin in the typical sense (e.g., patient demographics). All testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a physical medical instrument, not a diagnostic or AI-driven software. The "ground truth" for its performance is established through engineering and material science standards and physical measurements, not interpretation by human experts (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are non-clinical, objective measurements against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. No MRMC study was conducted. This type of study involves human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This device is a catheter and does not involve image interpretation or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This device is a physical catheter, not an algorithm or AI software. Therefore, no standalone algorithm performance study was performed or is relevant.

7. Type of Ground Truth Used

• The "ground truth" refers to engineering design specifications, material science standards (e.g., tensile strength, burst pressure limits), and relevant international standards (ISO standards) for medical device performance and biocompatibility. For instance, for dimensional verification, the ground truth is the specified engineering drawing dimensions. For biocompatibility, the ground truth is the absence of toxic, sensitizing, irritant, or pyrogenic effects as defined by ISO 10993 series.

8. Sample Size for the Training Set

• Not Applicable. There is no AI component or machine learning model that requires a training set for this device.

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

• Not Applicable. As there is no training set, this question is not relevant.

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