Search Results

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.

Ask a specific question about this device

The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravasular 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 Balloon Guide Catheter can also be used as a conduit for retrieval devices.

The Branchor Balloon Guide Catheter has the same design, materials and accessories as the predicate device (K203723). The change to the subject device includes performance testing and labeling to allow use with a power injector.

This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon quide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of this balloon quide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the quidewire and other devices through the section.

This is a 510(k) Pre-Market Notification submission for a medical device, which focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML device, and therefore the concepts of "acceptance criteria for an AI device," "experts used to establish ground truth," "adjudication methods," "MRMC studies," "standalone performance," or "training set" are not applicable in the context of this document.

The document describes non-clinical bench testing for the Branchor Balloon Guide Catheter to support its use with power injectors. The acceptance criteria and the study are as follows:

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

Since this is a substantial equivalence submission for a non-AI device, the "acceptance criteria" here refer to the performance standards met during non-clinical bench testing. The document states that the device "met all acceptance criteria" without explicitly listing numerical thresholds for each test. However, it reports a general "Pass" for each test.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench test (Burst Pressure, Power Injection, Flow Rate). It refers to "non-aged and aged devices" being tested, implying multiple units were used.
• Data Provenance: The tests were "non-clinical bench testing," meaning they were conducted in a laboratory setting. The country of origin of the data is not specified, but the applicant is ASAHI INTECC CO., LTD from Japan, with ASAHI INTECC USA, Inc. as the primary contact. The tests are prospective in nature, as they assess the performance of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a non-clinical bench study for a medical device, not a study involving ground truth established by human experts.

4. Adjudication method for the test set:

Not applicable. There is no adjudication method as this is not a study assessing interpretations or diagnoses.

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 non-AI medical device; therefore, MRMC studies and human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is a non-AI medical device.

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

For this type of device, "ground truth" is established by direct physical measurements and observations of the device's mechanical and functional performance under specified test conditions in a laboratory setting, rather than clinical outcomes or expert consensus. For example:

• Burst Pressure: Ground truth is the physical bursting pressure measured.
• Power Injection: Ground truth is the device's ability to withstand the forces and pressures of power injection without failure and maintain patency for flow.
• Flow Rate: Ground truth is the measured flow rate through the device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and does not involve a training set.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device