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The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.

The HYPERGLIDE Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a 0.010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall. The HYPERGLIDE Occlusion Balloon System is currently cleared for commercial distribution in sizes 4x10, 4x15, 4x20, 5x15 and 5x20. The System is packaged with a 0.010" X-pedion™ hydrophilic guidewire, also manufactured by Micro Therapeutics Inc. d/b/a ev3 Neurovascular, and cleared under K982543. The System is packaged in a sterile pouch and is for single use only.

The provided 510(k) summary (K092495) describes a modification to the HYPERGLIDE™ Occlusion Balloon System. This submission pertains to an occlusion balloon catheter, a physical medical device, not an AI/ML or diagnostic software device. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, training/test sets, ground truth establishment, expert qualifications, adjudication methods, and standalone performance) are not applicable to this type of submission.

The summary focuses on demonstrating substantial equivalence to previously cleared predicate devices through nonclinical bench testing.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was subjected to various tests to demonstrate substantial equivalence. The specific acceptance criteria themselves are not numerically detailed in this summary; rather, it implies that the new 3mm balloon size met the same performance specifications as the existing cleared sizes.

Study Proving Acceptance Criteria Met:

The study proving the device meets its acceptance criteria is referred to as "various testing" or "nonclinical data". This involved a series of bench tests that are standard for evaluating the mechanical and physical performance of medical devices like occlusion balloon catheters.

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

• Sample Size: Not explicitly stated in the summary. For nonclinical bench testing, the sample size would typically refer to the number of devices or components tested for each specific test (e.g., N=10 for burst testing, N=X for fatigue testing). The summary does not provide these specific numbers.
• Data Provenance: The data is nonclinical (bench testing), meaning it was generated in a lab setting, not from patients or animals. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable.

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

• Not Applicable. This is not an AI/ML or diagnostic study requiring expert adjudication of data. The "ground truth" for these tests are physical measurements and outcomes based on engineering specifications and test protocols (e.g., a balloon either bursts at a certain pressure or it doesn't; its dimensions are X or Y).

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, this is nonclinical bench testing. The results are typically objectively measured and verified against predetermined engineering specifications, not subject to expert adjudication in the way clinical diagnostic studies are.

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

• No. An MRMC study is relevant to diagnostic interpretation by human readers, often with and without AI assistance, using clinical images/cases. This submission is for a physical medical device (balloon catheter), not a diagnostic tool, and involves no human interpretation of data for diagnostic purposes in the context of this submission.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not Applicable.

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

• No. "Standalone performance" in this context refers to AI algorithm performance. This device is not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Test Protocols: The "ground truth" for the nonclinical tests would be the established engineering specifications for the device (e.g., a minimum burst pressure, maximum inflation/deflation time, specific dimensional tolerances). The actual test results are then compared against these objective criteria.

8. The Sample Size for the Training Set

• 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

• Not Applicable. There is no "training set" for this type of submission.

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The HyperGlide™ Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HyperGlide™ Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.

The HyperGlide™ Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a .010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end, redirecting inflation media to the balloon through side-holes in the catheter wall. The HyperGlide™ Occlusion Balloon System is currently cleared for commercial distribution for sizes 4x10, 4x15, 4x20, and 4x30. The HyperGlide™ Occlusion Balloon System is packaged with a .010" Xpedian™ hydrophilic guidewire, manufactured by Micro Therapeutics, Inc., d/b/a ev3 Neurovascular and cleared under K982543. The device is sold and packaged with a .010" guidewire in a sterile pouch and for single use only.

Here's an analysis of the provided text regarding the HyperGlide™ Occlusion Balloon System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with recognized standards rather than specific quantitative acceptance criteria that are often seen for AI/ML devices. Therefore, the table below reflects this approach.

2. Sample Sizes and Data Provenance

This submission is for a medical device (occlusion balloon catheter), not an AI/ML device. Therefore, it does not involve test sets or data provenance in the context of AI/ML algorithm evaluation. The "data" here refers to engineering test results and comparisons to predicate devices. The document does not specify exact sample sizes for each individual engineering test (e.g., how many balloons were burst tested), but indicates a comprehensive battery of tests was performed.

3. Number of Experts and Qualifications

Not applicable. This is a traditional medical device submission, not an AI/ML submission requiring expert ground truth establishment for an algorithm.

4. Adjudication Method

Not applicable for a traditional medical device submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, so there's no "human readers improve with AI vs without AI assistance" study.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The "ground truth" for this device, in a physical sense, is established by:

• Engineering Standards: Adherence to recognized international standards like ISO 10555.
• Mechanical Properties: Direct measurement and verification of physical and mechanical performance metrics (e.g., burst pressure, tensile strength, fatigue life).
• Predicate Device Equivalence: Direct comparison of design, materials, and performance to previously cleared, similar devices.

8. Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the HyperGlide™ Occlusion Balloon System meets its acceptance criteria is described as a series of performance verification and testing activities. These tests were conducted according to established international standards, specifically ISO 10555 (Sterile, Single Use Intravascular Catheters - Parts 1 and 4).

The testing encompassed various critical aspects of the device's functionality and safety, including:

• Dimensional verification
• Balloon fatigue
• Catheter tensile strength
• Torque strength
• Flexibility
• Burst testing

The submission explicitly states that "The test results demonstrated in this submission meet or exceed the requirements of these standards". This statement serves as the primary evidence that the device satisfies its performance acceptance criteria.

Furthermore, a significant part of the "proof" also relies on demonstrating substantial equivalence to predicate devices (the HyperGlide™ Occlusion Balloon family and HyperForm™ Occlusion Balloon System). This involved showing that the new 5mm version shared identical intended use, design, specifications, materials, construction methods, packaging, and sterilization processes with its cleared predecessors. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and demonstrations are sufficient to establish safety and effectiveness for marketing.

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The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.

The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.

The Medtronic AVE Solstice™ Temporary Occlusion Balloon System (K994141) is a medical device designed for temporary vascular occlusion. This document summarizes the acceptance criteria and the study used to establish its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The provided text, a Summary of Safety and Effectiveness for a 510(k) submission, describes the general approach to demonstrating safety and effectiveness rather than a specific table of acceptance criteria with numerical performance targets. The overall acceptance criteria are implied to be achieving equivalence in intended use, design, and physical characteristics to the predicate device, the MTI Equinox™ Occlusion Balloon System (K990487).

The reported device performance is stated broadly: "Based on in-vitro and in vivo testing results, Medtronic AVE believes the Solstice and QS 10 are safe and effective for their intended use."

To provide a structured table, we can infer the categories of acceptance criteria based on the testing performed.

2. Sample Size and Data Provenance

The provided text does not specify the exact sample sizes used for the "physical bench testing," "biocompatibility," and "animal studies." It states that "Testing was conducted on final, testing, mounted catheters and QS 10 Guidewires."

The data provenance is not explicitly stated in terms of country of origin. The studies are described as "animal studies" and "in-vitro testing," suggesting laboratory and preclinical environments. The nature of the submission (510(k)) implies the data is retrospective, as it was gathered prior to the submission for regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the use of experts to establish a "ground truth" in the context of human-readable data (e.g., image interpretation). The evaluation focuses on the physical and biological performance of the device through bench and animal testing. Therefore, this section is not applicable in the context of the provided information. If this were a clinical study with human outcomes data requiring expert interpretation, then such information would be relevant.

4. Adjudication Method

Since the assessment is based on physical bench testing, biocompatibility, and animal studies, and not on human-interpreted data, an "adjudication method" as typically understood in clinical trials (e.g., 2+1 reading) is not applicable. The assessment would have been based on pre-defined test protocols and measurable outcomes from the various tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human readers interpret images or other data, and the focus is on how an AI system might improve human performance. The Medtronic AVE Solstice™ is an interventional device, and its evaluation is based on its physical properties and in-vivo performance, not human interpretive accuracy.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation (algorithm only, without human-in-the-loop) is not applicable for this device. The device itself is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, evaluated through physical, chemical, and biological testing, not through algorithmic output.

7. Type of Ground Truth Used

For the safety and effectiveness studies, the "ground truth" was established through:

• Bench Test Results: Measurable physical and mechanical properties of the device (e.g., balloon inflation/deflation times, material strength, integrity under stress).
• Biocompatibility Standards: Compliance with established biological safety standards for medical devices (e.g., lack of cytotoxicity, sensitization, irritation).
• Physiological Outcomes in Animal Models: Direct observable and measurable effects in living animal models (e.g., successful vascular occlusion, no adverse tissue reactions, patency after occlusion removal).

These are objective, direct measurements and observations, not expert consensus on an interpretation of data.

8. Sample Size for the Training Set

The concept of a "training set" is primarily relevant for AI/ML algorithms. Since this is a physical medical device and not an AI solution, there is no training set in the traditional sense. The manufacturing process and quality control would involve statistical sampling during production and validation, but this is distinct from an AI training set.

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

As there is no "training set" for an AI algorithm, this question is not applicable. The "ground truth" for the device's performance was established through rigorous physical, chemical, and biological testing according to established medical device standards and protocols, as outlined in earlier sections.

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