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The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment.

This document describes the HydroCoil Embolic System (HES), specifically the HydroFrame® 10 for neurovascular and peripheral vascular embolization.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the "Result" column, which uniformly states "All test samples passed testing", "Non-toxic", "No sensitizer response", "Non-irritant", "Non-hemolytic", "No adverse effect on coagulation time", "Non-pyrogenic", and "Negative response for mutagenicity". The specific quantitative thresholds for "passing" are not explicitly stated in this summary but would be detailed in the full test reports (e.g., PDH-HFRM-ATP for visual inspection).

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

• Sample Size: The document repeatedly states "All test samples passed testing" but does not specify the precise number of samples used for each test. This information would typically be found in the detailed test protocols or reports referenced (e.g., PDH-HFRM-ATP).
• Data Provenance: The tests performed are pre-clinical bench and biocompatibility laboratory tests. The country of origin of the data is not explicitly stated, but the company, MicroVention, Inc., is based in Tustin, California, USA, suggesting the testing was likely conducted in the USA or by labs compliant with US regulatory standards. Since these are in-vitro and animal tests, they are inherently prospective as they are specifically conducted for this submission.

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

This document describes technical and biological tests, not studies requiring expert human interpretation of medical images or conditions to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists, pathologists) does not apply here. The "ground truth" for these tests is established by the predefined pass/fail criteria and objective quantitative measurements of the device's physical and biological performance against established standards (e.g., ISO 10993 series for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes among multiple human reviewers for clinical endpoints or image interpretation. The tests described are objective performance and biocompatibility assays with predefined pass/fail criteria.

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

No MRMC comparative effectiveness study was mentioned or performed. The document focuses on demonstrating substantial equivalence through technical and biocompatibility performance data, not through human reader performance with or without AI assistance.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. The HydroCoil Embolic System is a physical medical device (coils for embolization), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant. The performance evaluated is the device's physical and biological function.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Quantitative Bench Test Specifications: Predefined engineering and performance specifications for physical characteristics like dimensions, forces, and material properties.
• Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological response to medical devices. These standards define the acceptable biological reactions (e.g., non-toxic, non-irritant).

8. Sample Size for the Training Set

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

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

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

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The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The modified HES is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

The provided text describes a Special 510(k) submission for a modification to the HydroCoil Embolic System (HES), specifically to the HydroFill component. This is a submission demonstrating substantial equivalence to a predicate device, not a de novo clearance or a novel device submission. Therefore, the "acceptance criteria" discussed are primarily related to bench testing demonstrating that the modified device performs similarly to the predicate device, rather than clinical efficacy endpoints. The study described is a series of bench tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the "acceptance criteria" are implied by demonstrating that the modified device met the same criteria as the predicate device in a series of bench tests. The reported performance is that all tests met these implied criteria.

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

The document does not specify the exact sample sizes (number of devices or tests performed) for each bench test. It only states that the modified device "Met same criteria as predicate." The data provenance is internal to MicroVention, Inc., and is derived from bench testing (presumably in a laboratory setting). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in a clinical sense.

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

Not applicable. For bench tests demonstrating substantial equivalence, ground truth is established by engineering specifications, material properties, and performance benchmarks against the predicate device, not by expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is required to establish ground truth or resolve discrepancies. Bench tests rely on objective measurement and predefined engineering criteria.

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 a submission for a modification to a medical device (embolic coils), not an AI-powered diagnostic or therapeutic system. An MRMC study is not relevant to this type of device and submission.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests effectively consisted of the established performance and material specifications of the predicate device. The goal was to demonstrate that the modified device performed equivalently to these known specifications. This is an engineering/performance-based "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The data presented is from verification and validation bench testing of the physical device.

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

Not applicable. As noted above, there is no training set for this type of device.

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The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HydroSoft Plus HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.

With the exception of the coil dimensions (see comparison table below), the HydroSoft Plus line extension is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration and sterilization method.

This document describes the 510(k) summary for MicroVention, Inc.'s HydroCoil Embolic System (HES) - HydroSoft Plus Line Extension. This submission is for a medical device (neurovascular embolization device), not an AI/ML powered device, so many of the requested categories are not applicable.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study (bench testing) performed:

1. Table of Acceptance Criteria and the Reported Device Performance:

Predicate/Subject Device Comparison:

This table highlights the specific device characteristics that define the acceptance criteria for a "substantially equivalent" device:

Note on Differences: The "Implant diameter" and "Implant restrained length" are explicitly different between the predicate and subject devices. The core of this 510(k) submission is to demonstrate that despite these dimensional differences (which represent the "line extension"), the new device is still substantially equivalent in terms of safety and effectiveness, performing to "the same criteria as predicate" in the bench tests.

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

• Sample Size: The document does not specify the exact sample sizes for each bench test conducted (e.g., how many coils were subjected to "Weld Tensile" testing). It only states that the tests were performed and "Met same criteria as predicate."
• Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective, as these terms typically apply to clinical studies involving human or animal subjects, which is not the case for this type of submission.

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 510(k) submission based on bench testing of physical properties and performance, not diagnostic imaging or AI assessment that requires expert ground truth labeling. The "ground truth" for these tests is defined by established engineering and material science standards and the performance of the predicate device.

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

Not applicable. Adjudication methods are used in clinical trials or studies where subjective assessments or discrepancies in expert interpretations require resolution. Bench tests involve objective measurements against predefined specifications.

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 submission is for a physical medical device (coil embolization system), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The testing described is performance testing of a physical product.

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

The "ground truth" for the bench tests is the performance specifications and established criteria of the predicate device (K112226), along with general engineering and material science standards applicable to such devices. The new HydroSoft Plus line extension is considered to meet the acceptance criteria if its performance in these tests is "the same" as or equivalent to the predicate device.

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 physical device bench testing.

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The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The RD11-006 HES is a line extension which is substantially the same as the predicate devices (K070656, K080666, K091641). The implantable coil portion of both the predicate and the subject device is constructed from platinum alloy wire. The RD11-006 implantable coil is constructed of an oval-shaped platinum alloy wire, whereas the predicate devices are constructed of a round platinum alloy wire. All other materials and design features are the same for both the predicate and subject devices.

This document describes an FDA 510(k) summary for the HydroCoil Embolic System (HES) and asserts its substantial equivalence to a predicate device. It specifically focuses on a line extension with an oval-shaped platinum alloy wire, while the predicate devices used a round wire. There is no information in the provided text about a study (clinical or otherwise) that uses human readers, ground truth, or statistical analysis in the context of device performance. The entire submission is a declaration of equivalence based on bench testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document indicates that the acceptance criteria for the subject device are the "same criteria as predicate" for all bench tests. The reported device performance is that it "Met same criteria as predicate."

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

• Sample Size for Test Set: Not explicitly stated. The "Bench Test Summary" implies testing of device features, but the number of units tested is not provided.
• Data Provenance: The data is from bench testing, presumably conducted by the manufacturer, MicroVention, Inc., in the USA (Tustin, California). It is not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.

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

This is not applicable as the provided document details a 510(k) submission for a medical device (embolic coils) where the primary evidence presented is bench testing for substantial equivalence to a predicate device. There is no mention of a performance study involving human readers or experts to establish ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set:

This is not applicable for the reasons stated above. The evaluation is based on objective measurements from bench tests, not expert adjudication of diagnostic images or outcomes.

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 an embolic coil, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device based on the information provided.

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 implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is related to the physical and mechanical properties of the device. The "acceptance criteria" for the bench tests effectively serve as the ground truth against which the subject device's performance is measured. This includes:

• Meeting dimensional specifications.
• Achieving established thresholds for mechanical properties (e.g., spring constant, weld tensile strength, advancement/retraction force).
• Performing as expected during simulated use (introduction, tracking, deployment, detachment).
• Exhibiting expected gel expansion characteristics.

These are objective, measurable characteristics that confirm functional equivalence to the predicate device.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of an embolic coil device submission for bench testing. The device is not learning from data.

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

This is not applicable for the reasons stated above.

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The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HydroCoil® Embolic System (HES) is based on electrical coil detachment. The HES consist of an implantable coil attached to a delivery system called a V-TRAK™ Delivery Pusher. The Delivery Pusher is a variable stiffness, stainless steel and tapered mandrel. Two silver electrical leads run along the outside of the mandrel from the proximal to the distal end. Platinum and stainless steel wires are wound around the distal end of the mandrel to form the electrical heater and provide kink-resistance. Two outer layers of PET tubing cover the distal end of the pusher assembly. A layer of polyimide tubing covers the proximal end. The proximal end of the HES coils incorporates a platinum coupler for attachment to the Delivery Pusher. A polyolefin elastomer filament is attached to the proximal end of the coil. This filament runs through the inner lumen of the coil coupler and is attached to the distal end of the Delivery Pusher.

The Delivery Pusher is powered by a hand-held, battery-powered V-GRIP™ Detachment Controller designed specifically for the HES. A gold-plated stainless steel connector at the proximal end of the Delivery Pusher is used to connect it to the Detachment Controller, The Detachment Controller is provided separately. The coil is delivered to treatment site on the Delivery Pusher through standard neuro-interventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the HES into the micro-catheter. Once the coil is deployed, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the Detachment Controller is turned on, the flow of current melts the polyolefin elastomer filament at the coupler/pusher junction resulting in coil detachment.

The provided text describes a 510(k) premarket notification for the HydroCoil® Embolic System (HES) and states that performance testing has demonstrated its equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot populate the table or answer most of the questions directly from the provided text.

Here's a summary of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified in the provided document.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

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

• Not specified in the provided document.

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

• Not specified in the provided document.

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 specified in the provided document. This device is an embolization coil system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable as this is a medical device (embolization coil system), not an algorithm.

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

• Not specified in the provided document. The performance testing aimed to show equivalence to predicate devices, likely based on engineering performance metrics (e.g., detachment reliability, coil stability, mechanical properties) rather than diagnostic accuracy against a "ground truth" as typically understood in AI/imaging studies.

8. The sample size for the training set

• Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.

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

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

Additional Information from the text:

• Device Name: HydroCoil® Embolic System (HES)
• Intended Use: Endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; also for vascular occlusion of blood vessels within the neurovascular system and peripheral vasculature.
• Regulatory Status: 510(k) cleared, determined to be "substantially equivalent" to predicate devices.
• Nature of Study: Performance testing was conducted to demonstrate equivalence to predicate devices, focusing on operating principle, method of applications for use, design, materials, packaging, and sterilization.

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The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The HydroCoil® Embolic System (HES) consists of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system dc-airing and coil detachment. The HES prominer platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junetion in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

The provided document is a 510(k) premarket notification for the HydroCoil® Embolic System (HES). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria based on detailed performance studies with clinical outcomes in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving it, sample sizes for test/training sets, expert consensus details, or MRMC studies.

Instead, it states the following:

1. Table of Acceptance Criteria and Reported Device Performance:

• This information is not present in the document. The document states that "Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils is equivalent in performance to the predicate devices." However, it does not provide specific acceptance criteria or the numerical results of this performance testing.

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

• This information is not present in the document.

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

• This information is not present in the document.

4. Adjudication method for the test set:

• This information is not present in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not present in the document. The device in question is an embolization coil, not an AI-assisted diagnostic tool.

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

• This information is not present in the document. The device is an embolization coil, not an algorithm.

7. The type of ground truth used:

• This information is not present in the document.

8. The sample size for the training set:

• This information is not present in the document.

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

• This information is not present in the document.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, indications for use, design, materials, packaging, and sterilization. It does not provide the detailed performance study data, acceptance criteria, or ground truth establishment methods typically found in clinical trials or AI algorithm validation studies.

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