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The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.

The VIA™ 17 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as coils/stents. The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches. The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic. Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping. In intravascular procedures, the device assists the physician in: - Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.

The provided text describes the 510(k) summary for the VIA™ 17 Microcatheter, focusing on its substantial equivalence to previously cleared predicate devices rather than a standalone clinical study to prove the device meets acceptance criteria in the traditional sense of AI/ML performance.

The document details rigorous nonclinical tests (bench testing, sterilization validation, packaging and shelf-life assessment, biocompatibility assessment, and simulated use testing in animals) to demonstrate this substantial equivalence. It does not describe an AI/ML device, nor does it present "accuracy," "sensitivity," or "specificity" metrics typically used for such devices.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance metrics of an AI algorithm) are not applicable to this submission.

However, I can extract information related to the acceptance criteria and the results of the nonclinical tests performed.

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)

• Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical bench test. It generally states "All units passed acceptance criteria" for each test, implying a sufficient number of units were tested to demonstrate compliance.
• Data Provenance: The tests are "bench testing," "simulated use testing in animals," "sterilization validation," "packaging and shelf-life assessment," and "biocompatibility assessment." This indicates lab-based, animal-based, and compliance-based testing rather than human clinical data. The country of origin for the data is not specified, but the applicant (Sequent Medical, Inc.) is based in Aliso Viejo, California, USA, suggesting the studies were conducted under US regulatory standards. The data is prospective for these tests, as they are performed specifically to evaluate the new device.

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 is not applicable as the studies are non-clinical, bench, and animal tests. "Ground truth" in this context refers to the defined physical, mechanical, chemical, and biological properties measured and compared against established standards or predicate device performance, not expert consensus on medical images or diagnoses.

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

• This is not applicable for non-clinical, bench testing, and animal studies.

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 is not applicable. The device is a microcatheter, not an AI/ML diagnostic tool that would involve human readers interpreting medical cases.

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

• This is not applicable. The device is a physical medical instrument, not an algorithm.

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

• The "ground truth" for the non-clinical tests is based on:
  • Defined physical and mechanical properties: Measured values (e.g., kink diameter, buckling force, tensile strength, flow rate, dimensions).
  • Compliance with international standards: (e.g., ISO 10555-1:2014, ISO 594-1:1986, ISO 594-2:1998, USP 24 ).
  • Comparison to predicate device performance: The performance of the VIA™ 17 Microcatheter was specifically compared to established performance characteristics of the VIA™ 21 Microcatheter (K150894), VIA™ and VIA™ PLUS Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).
  • Biological responses: For biocompatibility, "ground truth" is typically defined by the absence of adverse biological reactions as per ISO 10993 series and other relevant standards.
  • Simulated use in animals: This provides physiological "ground truth" for how the device performs in a living system without causing new risks.

8. The sample size for the training set

• This is not applicable as the device is not an AI/ML algorithm.

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

• This is not applicable as the device is not an AI/ML algorithm.

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The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

The VIA™ 21 Microcatheter is designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIATM 21 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.

The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

• Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.

The provided document describes the VIA™ 21 Microcatheter and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML performance evaluation are not applicable to this document. The document focuses on the physical and functional characteristics of a medical device (a microcatheter).

However, I can extract the acceptance criteria and performance data for the device itself based on the provided text.

Here's the information derived from the document, with "N/A" for sections not relevant to this type of device and study:

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

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

The document does not explicitly state sample sizes for each bench test, but refers to "Simulated Use Testing in Animals" with results summarized as "no new risks were identified and that the safety and effectiveness profile is similar to well-established comparison market-approved devices." This suggests animal testing was performed. The provenance is likely prospective as part of the device development and validation.

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

N/A. This is a physical device, and the testing involves engineering and materials science principles, not expert interpretation of outputs like in an AI/ML system.

4. Adjudication method for the test set

N/A. Not applicable to engineering bench testing.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

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

N/A. This is a physical medical device.

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

The ground truth for most of these tests relies on established engineering standards (ISO, ASTM, BS EN) and internal Sequent Test Methods (TM), which define acceptable physical, mechanical, and functional properties of catheters. For the biocompatibility testing, accepted biological endpoints (e.g., non-pyrogenic, non-toxic, non-hemolytic) serve as the ground truth.

8. The sample size for the training set

N/A. This is a physical medical device. There is no "training set" in the context of AI/ML.

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

N/A. This is a physical medical device.

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The VIA™ Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.

The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a stcerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Interventional devices and infusion of diagnostic and therapeutic agents can be delivered through the lumen of the catheter to the treatment site.

The VIA™ Microcatheter is a sterile single lumen device with a single distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ and VIA™ PLUS Microcatheter are available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches, respectively. For commercialization purposes the 0.027 inch diameter will be named the VIA™ Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.

The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.

Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

Here's a breakdown of the acceptance criteria and study information for the VIA™ Microcatheter based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow. This method is appropriate as the Via is primarily used to deliver non-liquid devices. |
| Tip Buckling | Tests force required for tip to buckle. | Internal test method | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per test method | Complete conformance to Sequent TM |
| Tracking Force | Tests force required to advance an interventional device through the microcatheter lumen. | Internal test method | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per test method | Complete conformance to Sequent TM |
| Steam Shaping and Shape Retention | Tests that microcatheter can be steam shaped to a clinically relevant angle and can maintain a minimum % of the initial angle after simulated use. | Internal test method | Clinically relevant angle maintained, minimum % of initial angle retained | Met performance specifications per test method | Complete conformance to Sequent TM |
| Shaft Tensile | Measures the ultimate tensile strength of all Pebax and Vestamid junctions along the length of the catheter shaft. | ISO 10555-1:2009 | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Complete conformance to standard |
| Hub-Shaft Tensile | Measures the ultimate tensile strength of the hub to shaft junction | ISO 10555-1:2009 | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Complete conformance to standard |
| Burst | Measures peak pressure before microcatheter burst/liquid leakage. | ISO 10555-1:2009 | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Complete conformance to standard |
| Coating Friction and Coating Integrity | Measures the average peak coating friction/lubricity. Coating integrity uses dye to test that coating remains adhered to catheter after simulated use. | Harland Medical Systems Coating Friction and Dye Test Methods FDA Guidance Document, Class II Special Controls for PTCA Catheters (section 12) (Issued 2010) | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Complete conformance to supplier test methods. In line with FDA guidance document on coating integrity. |
| Coating Adherence/Particulate | Measures particulate generated from the hydrophilic coating on exterior of microcatheter, as well as particulate generated from advancing an interventional device through the inner lumen of the microcatheter. | Internal test method FDA Guidance Document, Non-Clinical Engineering Tests for Intravascular Stents and Associated Delivery Systems (section 12) (Issued 2010) FDA Guidance Document, Class II Special Controls for PTCA Catheters (section 13) (Issued 2010) | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Complete conformance to Sequent TM. In line with FDA guidance documents on particulate testing. |
| Hub Performance | Tests hub liquid and air leakage, as well as that the hub can withstand adequate forces. Tests that the hub meets general requirements for conical fittings. | ISO 594-1:1986 ISO 594-2:1998 Internal test method | Not explicitly stated (implied by "Met performance specifications") | Met performance specifications per standard and test method | Conformance to standard with the following deviations:
Used an alternative ISO 594-2:1998 fitting to test hubs for Separation Force and Unscrewing Torque. The fitting used was measured to have a minor diameter greater than called for in the standard. This was deemed as worst case for these tests, therefore acceptable to use.
Only short term stress cracking was inspected for on hubs. ISO 594-2:1998 calls for inspection after 48 hours. Intended use of Via microcatheter only requires RHV or syringes to be connected for short durations during delivery of implant, therefore long term testing is not applicable. |

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

The provided text only mentions "bench tests performed" and "simulated use testing in animals." It does not specify the sample size for the test set (number of catheters tested for each bench test) or the data provenance (e.g., country of origin, retrospective or prospective).

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

Not applicable. This device is a microcatheter, and the evaluation relies on physical and functional bench testing, and simulated animal use, not on human interpretation of images or data requiring expert consensus or ground truth in the typical clinical AI context.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC study was done. This is a medical device (microcatheter), not an AI algorithm for diagnostic interpretation. The evaluation focuses on the device's physical and functional performance, not on improving human reader performance.

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

This question is not applicable to a physical medical device like a microcatheter. The "standalone" performance here relates to the microcatheter's ability to perform its intended functions (e.g., track, burst pressure, kink resistance) as per its design specifications. The performance data presented in the table represents the standalone performance of the device against predefined technical specifications and standards.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• International Standards: ISO 10555-1:2009, BS EN 13868:2002, ISO 594-1:1986, ISO 594-2:1998.
• FDA Guidance Documents: Class II Special Controls for PTCA Catheters (sections 12 & 13) and Non-Clinical Engineering Tests for Intravascular Stents and Associated Delivery Systems (section 12).
• Supplier Test Methods: Harland Medical Systems Coating Friction and Dye Test Methods.
• Sequent Medical Internal Test Methods (Sequent TM): For tests like Tip Buckling, Tracking Force, Steam Shaping and Shape Retention, Coating Adherence/Particulate, and Hub Performance.

Essentially, the "ground truth" is defined by the technical specifications, performance limits, and methodologies outlined in these various standards and internal protocols.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices undergoing bench and simulated use testing.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The VIATM Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral and coronary vasculature.

The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIA™ Microcatheter is a sterile single lumen device with one distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ and VIA™ PLUS Microcatheter is available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches respectively. For commercialization purposes the 0.027 inch diameter will be named the VIATM Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.

The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

• . Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as , contrast and infusion of therapeutic agents.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating "substantial equivalence" to predicate devices rather than establishing novel safety and effectiveness criteria through studies like those for AI/ML devices. Therefore, much of the requested information (such as acceptance criteria, specific performance metrics, sample sizes for test sets, expert consensus for ground truth, and MRMC studies) is not typically present in this type of submission.

Here's a breakdown of what can be extracted based on the provided text:

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

The document does not explicitly present acceptance criteria in a quantitative table format that would typically be seen for AI/ML performance. Instead, it relies on demonstrating that the new device, the VIA™ Microcatheter, performs comparably to its cleared predicate devices. The "performance" is generally described as the device being able to be used for its intended purpose and showing "substantial equivalence" to the predicates.

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 mentions "Performance testing included: Bench Testing, Sterilization Validation, Packaging and shelf life testing, Biocompatibility testing, Simulated use testing in Animals."

• Sample Size: Not specified for any of these testing types.
• Data Provenance: Not specified. It can be inferred that animal testing would be prospective, but no details on the origin of the animals or other testing data are provided.

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

This information is not provided. The testing appears to be primarily engineering and biological validation rather than clinical studies requiring expert interpretation for ground truth.

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

Not applicable/not provided. This type of adjudication is typically for clinical image interpretation or diagnostic tasks, which are not the focus of this device’s validation.

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 device is a microcatheter, not an AI/ML diagnostic aid. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to its validation.

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 this device's validation is based on:

• Engineering specifications and regulatory standards: For bench testing of physical properties.
• Biological responses: For biocompatibility testing (e.g., cell culture tests, animal implantation responses).
• Sterilization efficacy: For sterility validation.
• Successful navigation and delivery: In "Simulated use testing in Animals." This would involve observing the physical device's performance in a live system.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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