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The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Transluminal BAV Catheter System features an hour glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour glass shaped balloon, with the undersized waist segment, is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

This document describes a 510(k) premarket notification for the "V8 Transluminal BAV Catheter" (K150343). The purpose of this submission is not to introduce a new device, but rather to update the labeling of an existing device (V8 Transluminal BAV Catheter, K133607) and establish its substantial equivalence to another predicate (Z-Med/Z-Med II, K122012).

The key finding is that no new performance data or studies were conducted for this specific submission (K150343) because the device design, materials, and function remain identical to the predicate V8 device (K133607). Therefore, the acceptance criteria and the studies proving the device meets them refer to previous submissions (K133607 and K123111).

Given this information, I will synthesize the available information regarding the acceptance criteria and prior studies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission explicitly states "no design changes have been made to the predicate K133607 V8 device" and "performance testing performed during design verification and shelf life testing were not repeated because the design and materials of the device remain the same as the V8 predicate," the acceptance criteria and performance are referred to the previous submissions. The document lists the types of tests performed in the predicate design verification. Specific quantitative acceptance criteria are not explicitly stated in this document but are implied by the successful completion of these tests in the predicate device.

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

This document does not provide details on sample sizes for test sets for the initial predicate device studies. It only states that the performance testing was not repeated because the design and materials are the same. Therefore, the sample sizes and data provenance would refer to the original K133607 and K123111 submissions. The nature of these tests (design verification, shelf life, biocompatibility) implies bench and potentially in-vitro/animal studies, rather than human clinical trials for this type of device. There is no mention of country of origin or retrospective/prospective for the previous studies within this document.

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

This request is primarily applicable to studies involving interpretation of data (e.g., medical images). The listed tests are primarily engineering and material performance tests (e.g., burst pressure, tensile strength, biocompatibility, sterility). For such tests, "ground truth" is typically established by objective physical measurements and adherence to recognized standards, rather than expert consensus on interpretive data. Therefore, this question is not directly applicable in the context of the provided document.

4. Adjudication Method for the Test Set

As explained above, the tests are primarily objective physical and material performance evaluations. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., radiographic interpretations). This is not relevant to the types of tests described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a medical device (a catheter) through bench testing, material characterization, and reference to prior regulatory submissions. MRMC studies are typically performed for diagnostic devices, especially those involving human interpretation of complex data (like imaging algorithms), to assess the impact of a device on reader performance.

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

No, this question refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The V8 Transluminal BAV Catheter is a medical instrument (hardware), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable.

7. The Type of Ground Truth Used

For the performance data referred to from the predicate submissions (K133607 and K123111), the ground truth for tests like burst pressure, compliance, critical dimensions, tensile strength, kink resistance, and torque would be established through:

• Objective physical measurements: Using calibrated equipment and standardized test methods.
• Chemical/Biological analysis: For biocompatibility and sterility, adhering to ISO standards and laboratory protocols.
• Engineering specifications: The device is designed to meet specific engineering tolerances and performance parameters.

Ground truths like expert consensus, pathology, or outcomes data would typically be used for diagnostic or treatment effectiveness studies involving patient data, which are not detailed here as the primary evidence for this 510(k) submission.

8. The Sample Size for the Training Set

This question is only relevant for artificial intelligence or machine learning models. The V8 Transluminal BAV Catheter is a physical medical device. Therefore, the concept of a "training set" is not applicable.

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

As explained above, there is no training set for this type of physical device.

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The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Transluminal BAV Catheter System features a figure-8 shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The figure-8 shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

This K133607 submission is for a device modification (V8 Transluminal BAV Catheter System), not for a new AI/ML-driven device. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, reader studies, etc.) are not directly applicable in this context.

The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, function, and identical intended use. The "acceptance criteria" here are the Special Control Requirements for Balloon Aortic Valvuloplasty (BAV) devices, and the "study" is the collection of design verification and shelf-life testing.

Here's the information broken down based on the provided document, adapted to the context of a device modification and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" refers to bench testing (design verification and shelf life testing) of the physical device and its components. The document does not specify exact sample sizes for each type of bench test, but indicates tests were repeated and performed before and after accelerated aging. This implies multiple units were tested.
• Data Provenance: Not applicable for a traditional test set as described for AI/ML. All data generated came from in-house device testing (bench testing and compatibility assessments). No patient data or external datasets were used to "test" the device.

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

Not applicable. The acceptance criteria and performance are based on engineering specifications and physical measurements, not on expert interpretations of data like in medical imaging.

4. Adjudication method for the test set

Not applicable. There was no need for expert adjudication, as the performance was evaluated against predefined engineering specifications for the physical device.

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, as this is a physical medical device (catheter), not an AI/ML-driven diagnostic or assistive tool.

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

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

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering specifications and ISO/ASTM standards for medical device components and performance (e.g., burst pressure, compliance, tensile strength, sterility, etc.). Data is compared against these predetermined, objective, quantitative metrics.

8. The sample size for the training set

Not applicable, as 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, as this is a physical medical device, not an AI/ML algorithm.

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The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Transluminal BAV Catheter System features an hour-glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour-glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

The provided text describes a 510(k) submission for the InterValve V8 Transluminal BAV Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions for novel devices is not fully present.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:

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

The submission demonstrates substantial equivalence based on technological characteristics and performance data from predicate devices, with relevant design verification testing repeated for minor modifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not detail a specific "test set" in the context of a new clinical study. Instead, it relies on:

• Design Verification Testing: For the minor modifications to the 24mm and 26mm balloons, all bonds and balloon characteristics were tested. The sample size for this specific testing is not provided. This would typically involve engineering tests on a batch of manufactured devices, not patient data.
• Clinical Experience of Predicate Device: The submission refers to "clinical experience used to support the change to the device labeling" and "Predicate device clinical experience showed that physicians may or may not employ the use of concomitant rapid ventricular pacing." The sample size, country of origin, or retrospective/prospective nature of this predicate clinical experience are not detailed in the provided text, as this information would have been associated with the original clearance of the predicate device (K123111).

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 as a formal clinical study with expert adjudication for a ground truth establishing accuracy was not conducted for this 510(k) submission.

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

This information is not applicable/none as a formal clinical study with expert adjudication was not conducted. The assessment relies on engineering testing and the established safety/efficacy profile of the predicate devices.

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. This submission is for a medical catheter, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance.

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

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

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

For the design verification testing of the modified balloon characteristics, the "ground truth" would be engineering specifications and performance standards for medical balloons (e.g., burst pressure, diameter at specified pressure, material integrity). For the labeling change regarding physician discretion, the ground truth appears to be current clinical practice and accepted industry standard ("The revised wording on the device labeling was changed to be consistent with how the devices are used by physicians, giving the physician the discretion... This is similar to the predicate devices and is accepted practice in the industry.").

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI.

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

This is not applicable.

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The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

The V8 Transluminal BAV Catheter System features an hour-glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour-glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

The provided text describes a 510(k) premarket notification for the "V8 Transluminal BAV Catheter" and references a predicate device, the "NuMed NuCLEUS-X BAV Catheter (K082776)". The study provided focuses on establishing substantial equivalence to the predicate device rather than presenting a performance study with detailed acceptance criteria against clinical efficacy.

Therefore, the response will focus on the engineering and biocompatibility aspects, as these are the primary details provided regarding performance.

Acceptance Criteria for the V8 Transluminal BAV Catheter and Reported Device Performance

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