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Intended for the endovascular embolization of:

• Intracranial aneurysms. .
• Other neurovascular abnormalities such as arteriovenous . malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature. .

The Boston Scientific Neurovascular Guglielmi Detachable Coil (GDCTM) is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDCTM Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDCTM Detachable Coil is detached (using the GDCTM Power Supply) by electrolytically dissolving a small portion of the delivery wire upon its desired placement within an aneurysm or other vascular site via a microcatheter. Multiple coils can be delivered into an aneurysm or other vascular site through the same microcatheter until the aneurysm or other vascular site is densely packed.

The acceptance criteria for the Guglielmi Detachable Coil (GDC™) are implicitly met by demonstrating substantial equivalence to the predicate device, specifically regarding an expanded indication for use. The primary basis for this expanded indication is the results of the International Subarachnoid Aneurysm Trial (ISAT).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The International Subarachnoid Aneurysm Trial (ISAT) included 2143 patients.
• Data Provenance: The study was an "International Subarachnoid Aneurysm Trial." While specific countries are not listed in the provided text, the name "International" suggests data from multiple countries. The study is a prospective, randomized trial, comparing two treatment methods.

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

The provided summary of the ISAT study focuses on the clinical outcomes of the patients rather than the establishment of a "ground truth" for diagnostic purposes by experts in a specific image interpretation scenario. The study's design as a randomized controlled trial inherently establishes the "truth" through patient outcomes (dependency or death at 1 year) following different interventions.

Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications in the context of interpreting medical images for device performance validation (as one might see in an AI/imaging device submission) is not directly applicable here. The "ground truth" is the observed clinical outcome of the patients in the trial, determined by standard clinical follow-up and assessment, not by expert consensus on a set of images.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the way it might for a diagnostic study. As a clinical trial comparing two interventions and their outcomes, the "adjudication" would refer to how patient outcomes (dependency or death) were assessed and classified during follow-up. While not detailed, such large-scale clinical trials typically employ:

• Standardized outcome measures: e.g., modified Rankin Scale for dependency.
• Blinded assessment (if feasible): Assessors of outcomes (e.g., neurologists) might be blinded to the initial treatment arm (coiling vs. clipping), though this is often challenging in interventional trials due to visible procedural scars or imaging findings that reveal the treatment.
• Independent monitoring committees: These committees often review adverse events and critical outcomes to ensure proper reporting and adherence to the study protocol.

The specific "2+1, 3+1" adjudication methods are typically for image interpretation tasks, which is not the primary focus of this clinical effectiveness study.

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

This was not an MRMC comparative effectiveness study in the traditional sense of evaluating human reader performance with or without AI assistance. The ISAT study was a direct clinical trial comparing two different medical interventions (endovascular coiling vs. neurosurgical clipping) in patients with ruptured intracranial aneurysms. It evaluated the effectiveness of the GDC™ device itself against the predicate surgical clipping, not a diagnostic algorithm's impact on human readers.

Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this study.

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

This was not a standalone performance study of an algorithm. The GDC™ is a physical medical device (detachable coil) for embolization, not a diagnostic algorithm. Its performance is intrinsically linked to the interventional procedure performed by a human clinician.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: The ground truth used was patient clinical outcomes at 1 year post-treatment, specifically the rates of dependency or death. This is based on direct observation of patient health status following the intervention.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable to this premarket notification as it pertains to a physical medical device and a clinical trial. The ISAT study is a pivotal clinical trial designed to test the device's expanded indication, not to train an algorithm. Previous clinical experience and trials would have informed the development and initial indications of the GDC™, but ISAT is the primary evidentiary support mentioned for this specific submission.

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

As explained above, a "training set" in the context of algorithm development is not relevant here. The ISAT study provides the evidence (the "truth" in a clinical trial sense) for the device's performance regarding an expanded indication. This "truth" was established through the rigorous methodology of a randomized controlled clinical trial, where patient characteristics, interventions, and outcomes were systematically recorded and analyzed by the ISAT Collaborative Group.

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The Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of the following components, each of which is sold separately:

• · GDC power supply
• · GDC occlusion coil attached to a delivery wire
• · set of GDC connecting cables
• · patient return electrode
• · two 9-volt batteries
  The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
  GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.
  Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K962503.
  The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:
• · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
• · Voltage display and indicator Displays the DC output voltage.
• · Time display Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
• · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
• · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Guglielmi Detachable Coil (GDC), specifically the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device Fibered GDC-18 VortX Shape Guglielmi Detachable Coil is being compared to its predicate device, the original Guglielmi Detachable Coil (GDC). The acceptance criteria are "established for predicate devices," and the reported device performance indicates that the Fibered GDC "Meets acceptance criteria established for predicate device."

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The verification tests listed are device-specific mechanical and physical tests, not clinical studies. Therefore, these tests typically involve a relevant number of devices to demonstrate reproducibility and meet statistical significance for product specifications, but the exact number is not provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document. The "tests" described are engineering/bench tests comparing the new device to its predicate, not studies requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As mentioned above, these are bench tests, not studies requiring adjudication by multiple readers or experts.

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 applicable and not provided in the document. This document describes a medical device (embolic coil), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device submission.

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

This information is not applicable and not provided in the document. As stated, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the verification tests is based on the acceptance criteria established for the predicate devices. This implies that the performance targets (e.g., specific friction values, tensile strength ranges, detachment times) of the predicate device serve as the benchmark for the new Fibered GDC. The document does not describe "pathology" or "outcomes data" as ground truth for these specific verification tests.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. As this is a medical device, there is no "training set" in the context of machine learning or AI. The development of such a device involves design specifications, material testing, and manufacturing process controls rather than data for algorithm training.

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

This information is not applicable and not provided in the document. There is no concept of "training set" or "ground truth for a training set" for this type of medical device submission.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:

a)very high risk for management by traditional operative techniques, or,

b) inoperable,

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.

The GDC system consists of:

• · GDC power supply
• · GDC occlusion coil attached to a delivery wire
• · set of GDC connecting cables
• patient return electrode
• · two 9-volt batteries

each of which is sold separately.

The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.

Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.

The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

• · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
• · Voltage diplay and indicator Displays the DC output voltage.
• · Time display Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
• · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
• · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

This document describes the safety and effectiveness of the Guglielmi Detachable Coil (GDC), a Class III artificial embolization device. The information provided focuses on the "Stretch Resistant GDC" and its comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes a "Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device". The acceptance criteria for most tests were established by the predicate device (K962503). For the "Main Coil Stretch Test," acceptance criteria were established for the modified device.

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

The document does not explicitly state the sample sizes used for each specific test mentioned in the "Verification Test Summary Table". It is a descriptive summary of test outcomes rather than a detailed study report with sample sizes.

The data provenance is not specified. However, given that this is a 510(k) submission for a medical device in the US, the testing and data generation would typically follow US regulatory guidelines and standards. It is retrospective in the sense that these tests were conducted to demonstrate substantial equivalence to a previously cleared device.

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

This document is a technical summary for regulatory submission, focusing on material and functional comparisons of a medical device (GDC coils). It does not involve "ground truth" derived from expert consensus on diagnostic interpretations (like for an AI algorithm). Instead, the performance is assessed against established engineering and safety standards, benchmarks set by the predicate device, or specific acceptance criteria defined for the modified device. Therefore, information about the number or qualifications of experts used to establish "ground truth" in this context is not applicable.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective engineering and material performance assessments, not subjective diagnostic interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. This document pertains to a physical medical device (embolization coil), not an AI algorithm for diagnostic assistance. Therefore, an MRMC study or the effect size of AI assistance on human readers is not relevant.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering specifications, performance benchmarks derived from the predicate device (K962503), or specific design requirements for the new "Stretch Resistant GDC." For example:

• Friction: Measured against a specific frictional force threshold.
• Tensile Strength, Main Coil Weld: Compared against a minimum tensile strength value.
• Detachment Time: Evaluated against a specified temporal range for detachment.
• Particulate Analysis: Absence of particulate generation.
• Heating Effects (Electrolysis, MRI): No increase beyond acceptable thresholds or predicate device performance.
• Tip Ball Strength: Compared against a minimum strength requirement.
• Main Coil Stretch Test: Evaluated against specific criteria established for the elasticity and resistance of the modified device.

These benchmarks and criteria are based on established medical device safety and efficacy standards and the performance history of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:

a)very high risk for management by traditional operative techniques, or,

• b) inoperable,
  and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The indications for use for GDC-10 3D Shape and GDC-18 3D Shape are identical to those for the predicate GDC device cleared under K962503.

The GDC system consists of

• · GDC power supply
• · GDC occlusion coil attached to a delivery wire
• · set of GDC connecting cables
• · patient return electrode
• · two 9-volt batteries

each of which is sold separately.

The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.

Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K962503.

The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

• · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
• · Voltage diplay and indicator Displays the DC output voltage.
• · Time display · Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
• · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
• · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

This document describes the GDC-10 and GDC-18 3D Shape Guglielmi Detachable Coils, which are artificial embolization devices. The submission focuses on demonstrating substantial equivalence to a predicate device (K962503). As such, the acceptance criteria and study information provided are primarily focused on the technological characteristics comparison and verification testing to show that the new device performs as well as the predicate.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 3D Shape GDC are primarily established by demonstrating that its performance "Meets acceptance criteria established for predicate device" or shows "No change made which would influence" certain characteristics, or establishes "equivalency."

Note: The document only refers to "acceptance criteria established for predicate device" without providing specific numerical values for those criteria. It focuses on the comparison and equivalence rather than absolute performance metrics for the new device.

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

The provided document does not specify the sample sizes used for the test sets in the verification tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The tests described (e.g., friction, tensile strength, detachment time, heating effects) are typically conducted in a lab setting on device samples rather than with patient data.

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

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations of physical and functional characteristics of the device, rather than studies requiring expert medical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (bench-top/engineering), an adjudication method as typically used in clinical studies with human readers would not be applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This document describes a 510(k) submission for a medical device (embolization coil), which typically relies on demonstrating substantial equivalence through technological comparison and verification testing, rather than clinical efficacy studies involving human readers and interpretations of medical cases.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (embolization coil) and does not involve an algorithm or AI component in the sense of image analysis or diagnostic support.

7. Type of Ground Truth Used

The "ground truth" for the verification tests is based on engineering specifications and established performance criteria for the predicate device. For tests like "Friction" or "Tensile Strength," the ground truth is a measurable physical property that must meet a predefined standard. For a test like "Coil Migration," the ground truth is the observation of "no movement" within the specified test conditions. These are objective engineering measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This information is not applicable/not provided. As this is a physical medical device (embolization coil) and not an AI/algorithm-based product, there is no "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reasons as above.

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See table below

Please refer to Table 1 (Page 10)

The provided text is a 510(k) summary for various medical devices by Target Therapeutics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional, chemical, biocompatibility, and sterile barrier tests.

This document does not contain information on acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, it details laboratory-based testing for physical and chemical properties and refers to section 6 of the submission for further details on these tests. There is no mention of a study involving human readers, ground truth established by experts, or AI performance metrics.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and studies based on the provided text. The document is for a traditional medical device submission, not an AI/ML-driven one.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, as well as compares its indications for use with predicate devices. It is a summary of safety and effectiveness, likely from a regulatory submission, but it lacks the specific details requested regarding performance studies.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovencus fistulae of the neuro vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, but it does not contain information regarding acceptance criteria, a specific study proving the device meets those criteria, or any details about AI/algorithm performance. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

Here's what I can infer from the given document, which is limited to the device description and intended use:

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

• Not applicable / Not provided in the text. The document does not describe specific acceptance criteria (e.g., success rates, complication rates, embolization effectiveness metrics) or report performance against such criteria.

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

• Not applicable / Not provided in the text. No "test set" in the context of algorithm evaluation is mentioned. The document describes expanding indications for an existing 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):

• Not applicable / Not provided in the text. No mention of ground truth establishment by experts for a test set. The document refers to "treating neurosurgical team" determining suitability for the GDC, but this is clinical decision-making, not ground truth for an AI study.

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

• Not applicable / Not provided in the text.

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 / Not provided in the text. No AI or algorithm is mentioned.

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

• Not applicable / Not provided in the text. No AI or algorithm is mentioned.

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

• Not applicable / Not provided in the text.

8. The sample size for the training set:

• Not applicable / Not provided in the text. No AI or algorithm training is mentioned.

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

• Not applicable / Not provided in the text. No AI or algorithm training is mentioned.

Summary of what the document does describe:

• Device Name: Guglielmi Detachable Coil (GDC)
• Device Description: Consists of a remote power supply and an occlusion coil attached to a delivery wire, detached electrolytically. Coils are platinum.
• Intended Use: Embolizing certain intracranial aneurysms (high risk or inoperable) and other vascular malformations (AVMs, AVFs) of the neuro vasculature.
• Expanded Indications: The document indicates an expansion of use to "other vascular lesions such as arteriovenous malformations (AVM) and arteriovenous fistulas (AVF)." This expansion is being sought based on substantial equivalence to predicate devices (other GDCs and Cook Occlusion Coils) already marketed for similar vascular lesions.

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