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The AXS Lift Intracranial Base Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end. The distal end of the catheter contains tallow derivatives of bovine origin. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.

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The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Toro 88 Superbore Catheter is a variable stiffness, single lumen catheter designed to introduce interventional devices into the vasculature. The catheter shaft design includes stainless steel and nitinol wires and polymers of varying durometers. The catheter incorporates an internal lubricious liner to facilitate its advancement over a steerable guidewire or microcatheter. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a hub with Luer lock. The catheter is supplied sterile, for single use only.

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The V-DAC Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral and neurovascular systems.

The V-DAC Catheter consists of 1) Distal Access Catheter and 2) Peel-Away Introducer Sheath.

The V-DAC Catheter is a single lumen, coil-reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. Complete dimensions of the catheter are included on the device label.

The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter.

The V-DAC Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only.

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The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.

The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.

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The Bendit17 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices.

Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

The Bendit®17 Microcatheter is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.

The total working length of the Bendit®17 Microcatheter is 151 cm. It is comprised of two Nitinol hypo tubes that are connected at their distal ends, with proprietary laser-cut patterns along the 38 cm distal section. The laser cuts give the Bendit®17 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 10 mm section is steerable and includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm proximally from the tip. The distal portion of the catheter shaft (100 cm) is covered with a hydrophilic coating.

Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit®17 lumen can accommodate compatible guidewires (≤ 0.014 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.

The Bendit®17 is compatible with the following types of therapeutic devices:

• Embolization particles with maximum particle size of 400 µm
• Coils with maximum coil wire size of 0.014''
• Stents/stent retrievers/intrasaccular flow disruption devices compatible with microcatheters with inner diameter of 0.017''

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The VersaD Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The catheter has a polytetrafluoroethylene (PTFE etched liner), the proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

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The Carrier XL Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

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The DUO Microcatheter is intended for the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

The DUO Microcatheter is a disposable, single use, sterile device. The DUO Microcatheter is a single-lumen, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 80 cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A steam shaping mandrel and a peel away introducer are provided with each microcatheter.

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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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The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.

The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.

The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices.

The dilator consists of two parts: (1) a shaft and (2) a connector.

The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.

The provided FDA 510(k) Clearance Letter for the FUBUKI XF-R Neurovascular Long Sheath describes the device and its demonstrated substantial equivalence to a predicate device. However, it does not contain information about a study involving an AI/algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested details regarding acceptance criteria, ground truth, expert opinions, and sample sizes for AI/algorithm performance studies cannot be extracted from this document because such a study was not conducted or reported for this submission. This is a medical device, specifically a catheter, not an AI/software device.

I will provide the information that is available in the document, framed as if it were a typical medical device clearance, rather than an AI/ML clearance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for FUBUKI XF-R Neurovascular Long Sheath

This clearance pertains to a physical medical device (a neurovascular long sheath), not an AI/software device. Therefore, the "acceptance criteria" and "study" refer to non-clinical bench testing and biocompatibility testing to demonstrate the device's physical performance, safety, and substantial equivalence to a predicate device. There is no AI component involved in this device or its clearance documentation.

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

The document states that the device met all acceptance criteria, but it does not specify the numerical acceptance criteria for each test. Instead, it lists the types of tests performed and the conclusions.

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 or biocompatibility test. It only states that testing was "performed." For biocompatibility, it refers to standard ISO test methods (e.g., "Rabbit Pyrogen Test" implies a certain number of rabbits, but the exact count isn't given).
• Data Provenance: Not explicitly stated, but typically, non-clinical lab testing data would originate from the manufacturer's own testing facilities or contract research organizations. No geographic origin is mentioned for the data, nor is it specified if the tests were retrospective or prospective; however, given that these are physical device tests for a 510(k) submission, they would inherently be prospective (i.e., new tests conducted specifically for this submission).

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

This information is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically reserved for diagnostic devices, particularly those involving image interpretation or clinical decision support, or AI/ML-driven devices. For a physical medical device like a catheter, "ground truth" is established through standardized engineering and biological tests (e.g., tensile strength, fluid flow, material composition, biological response), rather than expert clinical interpretation of data.

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

This is not applicable. Adjudication methods are relevant for clinical trials or multi-reader studies where there might be disagreement in expert assessment (e.g., image interpretation). For bench and biocompatibility testing, results are quantitative or qualitative based on predefined scientific standards and validated test methods.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic devices, especially those that involve human interpretation assisted by algorithms (AI). This submission is for a physical percutaneous catheter, not a diagnostic or AI-assisted device. Therefore, a discussion of human reader improvement with AI assistance is not relevant to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

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

The "ground truth" for this medical device is based on:

• Predefined engineering specifications and performance standards (e.g., dimensions, strength, lubricity).
• Validated test methods outlined in ISO standards (e.g., ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
• Chemical and material analysis.
• Biological responses observed in animal models (for biocompatibility).

This is fundamentally different from a ground truth established by expert clinical consensus, pathology, or outcomes data for diagnostic devices.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.

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