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The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vesscl selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms,

The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms.

The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic

The provided 510(k) summary for the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters does not include any acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The approach taken is that no new performance data specific to these devices was deemed necessary.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not applicable, as no new performance testing data is provided or referenced for these specific devices.
• Data Provenance: Not applicable. The basis for equivalence relies on the established performance and safety of predicate devices.

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

• Not applicable, as no new clinical or performance test data requiring expert review for ground truth establishment is presented.

4. Adjudication Method for the Test Set:

• Not applicable, as there is no test set or related adjudication process described.

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

• No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance or human-in-the-loop performance studies.

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

• Not applicable. This device is a medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Not applicable. As no new performance or clinical studies were conducted for these devices, there was no ground truth established for them. The safety and effectiveness are inferred from the predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria (based on the provided document):

The "study" proving the device meets acceptance criteria is primarily a comparison to predicate devices to demonstrate substantial equivalence, rather than direct performance testing of the new devices.

• Mechanism of Proof: The submission aims to prove substantial equivalence by highlighting the shared characteristics with legally marketed predicate devices. The core argument is stated as: "The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices."
• Key Similarities Listed for Substantial Equivalence:
  • Same intended use (all predicates)
  • Same balloon technology and specifications (all predicates)
  • Same catheter technology and characteristics (all predicates)
  • Same other product technology and specifications (all predicates)
• Predicate Devices:
  • Equinox Occlusion Balloon Catheter (K001237)
  • HyperForm Occlusion Balloon Catheter (K011656) (Note: This suggests an update or re-submission for an existing HyperForm catheter)
  • HyperGlide Occlusion Balloon Catheter (K011526, K090728) (Note: Similar to HyperForm, suggests updates/re-submissions for existing HyperGlide catheters)
• Conclusion: Based on these similarities in intended use, technological characteristics, and prior performance (of the predicate devices), Micro Therapeutics, Inc. (dba ev3 Neurovascular) concluded that the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the listed predicate devices. The FDA concurred with this determination for market clearance.

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

The HyperGlide™ Occlusion Balloon Catheter is a single lumen balloon catheter with at maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperGlide catheter is supplied sterile for single use or as a system, which includes the required 0.010" guidewire.

The provided documentation for the Micro Therapeutics, Inc. HyperGlide™ Occlusion Balloon Catheter does not describe a study involving an AI device or algorithm, and thus does not contain the specific information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 related to AI device performance, sample sizes for test/training sets, expert ground truth, or adjudication methods.

Instead, this document is a 510(k) Summary for a conventional medical device (an occlusion balloon catheter), detailing its substantial equivalence to a predicate device based on performance testing against established standards.

Here's an analysis of what the document does provide regarding acceptance criteria and testing:

Acceptance Criteria and Study for the HyperGlide™ Occlusion Balloon Catheter (Non-AI Device)

The "TESTING" section of the 510(k) Summary states: "Performance testing of the HyperGlide catheter was conducted in accordance with ISO 10555 Sterile, Single Use Intravascular Catheters- Parts 1 and 4 and Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, and Intravascular Stents (Draft May 1995)."

This indicates that the acceptance criteria are implicitly defined by the requirements outlined in these standards and guidance documents. These standards typically cover aspects such as:

• Sterility: Ensuring the device is free from microorganisms.
• Biocompatibility: Showing the device material is safe for contact with the body.
• Physical and Mechanical Performance: This would include criteria related to:
  • Catheter dimensions: Outer diameter, length, balloon dimensions.
  • Inflation/deflation time for the balloon.
  • Burst pressure/integrity of the balloon.
  • Trackability/pushability (how easily it navigates through vessels).
  • Tensile strength (resistance to breaking).
  • Connection strength (e.g., between balloon and catheter shaft).
  • Guidewire compatibility: Ensuring it tracks over the specified guidewire.
  • Hydrophilic coating integrity.
  • Radiopacity of markers.
• Packaging integrity.
• Shelf life.

Study that Proves Device Meets Acceptance Criteria:

The document states that "Performance testing" was conducted. This implies a series of laboratory-based, benchtop, and potentially in vitro (or ex vivo) tests designed to verify adherence to each specific requirement within the cited ISO standards and FDA guidance.

Specific Information Requested (and why it's not present for this document):

1. Table of acceptance criteria and reported device performance:

   • Not provided in the summary. The summary states that performance testing was done according to standards, but does not list the specific numerical criteria or the measured performance values. This level of detail would typically be found in the full 510(k) submission and associated test reports, not a public-facing summary.

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

   • Not applicable/Not provided for this type of device and study. For mechanical device testing, sample sizes are usually determined by statistical methods for specific tests (e.g., n=5 or n=10 for burst pressure, tensile strength, etc.) to ensure statistical significance for demonstrating reliability. Data provenance would be from internal lab testing.

3. Number of experts used to establish ground truth and qualifications:

   • Not applicable. This pertains to studies where human interpretation (e.g., image reading) is a component of the ground truth. For a physical device like a catheter, "ground truth" is measured repeatedly and objectively by laboratory equipment and calibrated tools.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is relevant for consensus-based ground truth (e.g., expert panel review). Physical performance testing does not involve adjudication.

5. MRMC comparative effectiveness study, effect size of human improvement with AI:

   • Not applicable. This device is not an AI algorithm.

6. Standalone (algorithm-only) performance:

   • Not applicable. This device is not an AI algorithm.

7. Type of ground truth used:

   • Direct physical measurement against established engineering and safety standards. For example, the "ground truth" for balloon burst pressure is the pressure at which the balloon statistically fails, measured by a manometer and pressure test rig. The "ground truth" for trackability might be a subjective assessment by an engineer navigating it through a tortuous path model, or quantifiable metrics like force required.

8. Sample size for the training set:

   • Not applicable. This device is not an AI algorithm that learns from data.

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

   • Not applicable. This device is not an AI algorithm.

In summary: The provided document describes a regulatory submission for a physical medical device. It attests that the device underwent performance testing in accordance with relevant international standards and FDA guidance to demonstrate its substantial equivalence to a predicate device, but it does not involve any AI technology or the associated study design elements relevant to AI validation.

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