(48 days)
The Azur Detachable 18 Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The coils 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 embolization in the peripheral vasculature.
The Azur Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).
The provided text describes a 510(k) premarket notification for the Azur Detachable 18 Coil System, a vascular embolization device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing, rather than a clinical study evaluating device performance against specific acceptance criteria in a human patient population. Therefore, many of the requested elements for a study proving device meets acceptance criteria are not directly available in this document.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance
The acceptance criteria are generally "Met established criteria" for various bench tests. Specific quantitative thresholds for these criteria are not detailed in this summary document.
| Bench Testing | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Met established criteria | Met established criteria |
| Dimensional Measurement | Met established criteria | Met established criteria |
| Tracking | Met established criteria | Met established criteria |
| Repositioning- Deployment | Met established criteria | Met established criteria |
| Placement - Stability | Met established criteria | Met established criteria |
| Detachment Test | Met established criteria | Met established criteria |
Note: The provided document is a 510(k) summary, which often omits the detailed quantitative acceptance criteria and raw data that would be present in the full 510(k) submission.
Study Information
The document describes bench testing, not a human clinical study. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial to prove safety and effectiveness against specific clinical endpoints.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: Not applicable as this is bench testing, not clinical data from a specific country or population. It's an in-vitro evaluation.
- Retrospective or Prospective: Not applicable as it's bench testing.
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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. Bench testing does not involve human experts establishing a "ground truth" in the clinical sense. The "ground truth" for bench tests would be defined by engineering specifications and standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to bench testing. The evaluation is against engineering specifications.
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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 device is a physical embolization coil, not an AI diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in a clinical sense. The "ground truth" for the bench tests would be the established engineering specifications and performance parameters for the device, and comparison to the predicate device's known performance.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable for the reasons stated above.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).