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The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The exterior surface of the distal 120cm catheter length is treated with a hydrophilic coating.

The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.

The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.

Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.

For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.

All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.

The provided text does not contain detailed information about acceptance criteria, device performance,
or a study comparing the device against specific criteria in the way typically found for AI/ML-based
medical devices. The document is a 510(k) summary for a physical medical device—the IsoFlow™
Infusion Catheter—seeking substantial equivalence to predicate devices.

Therefore, many of the requested categories (such as sample size for test set, number of experts,
adjudication method, MRMC study, standalone performance, training set details) are not applicable
to this type of submission and are not present in the provided text.

However, I can extract the information that is present concerning the device's characteristics and its
comparison to predicate devices, which forms the basis for its acceptance (i.e., substantial
equivalence) by the FDA.

Here's a summary based on the provided text, addressing the applicable points:

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

For a traditional medical device like the IsoFlow™ Infusion Catheter, "acceptance criteria" are
typically demonstrated through substantial equivalence to legally marketed predicate devices, along
with adherence to performance standards and safety testing (which are summarized, but not detailed
in a quantitative study in this specific 510(k) summary). The performance is shown by demonstrating
that the device's characteristics are "Substantially Equivalent" to the predicates.

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

Not applicable. The document describes a 510(k) submission for a physical medical device (infusion
catheter), not an AI/ML device relying on a test set of data. The "study" here is the comparison of
the device's characteristics to predicate devices.

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

Not applicable. This information is typically relevant for AI/ML device evaluations. For this traditional
medical device, "ground truth" mainly refers to the functional and material specifications meeting
established medical device standards and being comparable to legally marketed devices.

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

Not applicable. This is not relevant for the type of device and submission described.

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 type of study is for AI/ML-assisted diagnostic or therapeutic devices, not for
a physical infusion catheter.

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

Not applicable. This is for AI/ML devices. The IsoFlow™ Infusion Catheter is a physical device
used by a physician.

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

Not applicable in the context of an AI/ML device. For this physical catheter, the "ground truth" for
its acceptance is established through:

• Engineering design specifications and material science: Ensuring the catheter is constructed
  from biocompatible materials and designed to safely perform its intended functions.
• Comparison to predicate devices: Demonstration of substantial equivalence in intended use,
  technological characteristics (physical description, anatomical sites, design, materials), and
  performance. This implies that the predicate devices themselves have a history of safe and
  effective use.
• Performance testing: While not detailed in this summary, a 510(k) submission typically
  includes bench testing (e.g., burst pressure, tensile strength, flow rates, balloon integrity),
  biocompatibility testing, and sterilization validation to ensure safety and performance.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

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In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to ctructures structures.

The provided text is a 510(k) summary for the Mercator MicroSyringe II Infusion Catheter and does not contain the detailed information requested regarding acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML model.

This document describes a medical device clearance for an infusion catheter, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML performance, ground truth, expert review, training sets, and comparative effectiveness studies are not applicable or detailed in this submission.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

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 does not specify the sample sizes (e.g., number of units tested, number of in-vivo subjects) for the mechanical, fluid delivery, biocompatibility, sterilization, or in-vivo safety testing. It also does not state the provenance of the data (e.g., country of origin, retrospective or prospective).

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)

Not applicable. This is a medical device for infusion, not an AI/ML diagnostic or predictive device requiring expert-established ground truth in the context of image interpretation or similar. The "performance" assessment is based on engineering and biological testing.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes in that context. Device performance was likely assessed against engineering specifications and possibly animal studies in a direct, objective manner.

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 not an AI-assisted device, and no MRMC study information is provided.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance of this physical device would typically be defined by:

• Engineering specifications and standards for mechanical and fluid delivery performance.
• Relevant ISO standards and guidelines for biocompatibility and sterilization validation.
• Pre-clinical (in-vivo animal) study results for safety.

The document states that "All components, subassemblies and/or full devices met the required specifications for the tests," implying these specifications served as the ground truth or target.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

The Proxis Flow-Control device is a dual balloon catheter. It has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter System, and an Evacuation syringe.

The Evacuation Sheath also has two low-pressure compliant balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has an inner diameter of 0.058 inches and can accommodate standard therapeutic devices that have profiles of 0.058 inches or lower. The balloons are inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the Proxis balloons are inflated, and the vessel occluded. Infusing less than 0.5cc of contrast dye through the guide catheter will produce a "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, less than 0.5cc of therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device while the vessel is occluded.

The Evacuation syringe is provided in the event that removal of contrast, or therapeutic solution is desired. If distal perfusion of fluid is needed during evacuation, the Infusion Catheter System may be used.

Here's an analysis of the provided text regarding the Proxis Flow-Control Device, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document provides very high-level summaries of performance. Specific numerical acceptance criteria (e.g., "tensile strength greater than X N") and their corresponding measured values are not detailed in this 510(k) summary. The statement "device meets or exceeds the requirements of these standards" implies that the specific criteria outlined within each standard were successfully met.

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

• Sample Size:
  • Animal Studies: Nine acute animals and eight chronic animals. This constitutes the primary "test set" for in-vivo performance and safety.
  • Bench Testing: The sample sizes for dimensional verification, balloon compliance, tensile strength, torque strength, flexibility, and trackability are not specified in this summary. It simply states "performance testing included..."
• Data Provenance: The document does not explicitly state the country of origin for the animal studies. It is likely that these studies were conducted in the country where Velocimed Inc. is based (Minneapolis, MN, USA) or in a country with established regulatory frameworks for medical device animal testing. The animal studies are prospective in nature, as they were conducted to validate the device's performance and safety before market clearance.

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

This type of information is not applicable or not provided for this 510(k) summary. For a device like the Proxis Flow-Control Device, the "ground truth" during performance and safety testing is established through objective measurements (e.g., physical dimensions, strength tests, biocompatibility assays) and observation of physiological responses in animal models by veterinarians and researchers, rather than expert consensus on interpretive data (like radiology images).

4. Adjudication Method (for the test set)

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where there is subjective interpretation of data that needs consensus or tie-breaking by experts. For the type of performance and animal testing described here, the results are generally objective and measured, or observed directly by the testing personnel.

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

There is no MRMC comparative effectiveness study mentioned in this document. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers and their performance with or without AI assistance.

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

This information is not applicable or not provided. This device is a physical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm on its own, without human interaction.

7. The Type of Ground Truth Used

• Bench Testing: Objective physical measurements, adherence to engineering specifications, and compliance with international standards (ISO, ASTM).
• Animal Studies: Direct observation of physiological effects, safety assessments (e.g., lack of adverse tissue reactions, proper functioning within the vasculature), and performance characteristics (e.g., successful occlusion, delivery capability). The "ground truth" here is the biological and mechanical reality observed in the animal model.

8. The Sample Size for the Training Set

There is no "training set" mentioned or implied. This device is a physical medical device. The concept of a "training set" is primarily relevant to machine learning or AI algorithms, where data is used to train a model. For medical devices like this catheter, internal product specifications and engineering designs guide its development, and then independent testing (bench and animal) is conducted for validation.

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

As there is no "training set" for this physical device, this question is not applicable.

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