(83 days)
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The Micrus Deltapaq 10 Cerecyte Microcoil Systems consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)
Here's an analysis of the provided text regarding the Micrus "Deltapaq 10 Cerecyte" Microcoil System (K080437) and its acceptance criteria and supporting study:
Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate "substantial equivalence" to a predicate device, rather than rigorously proving performance against pre-defined acceptance criteria through a standalone study with a test set, ground truth, and expert adjudication in the way an AI/CAD device would. This document focuses on demonstrating that the new device is fundamentally similar to an already cleared device and thus doesn't raise new questions of safety or effectiveness. Therefore, many of the requested data points (e.g., sample size for test set, number of experts, adjudication method for ground truth, MRMC study, how ground truth for training set was established) are not applicable or not provided in this type of regulatory submission.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a device like a microcoil, the "acceptance criteria" are generally interpreted as demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing key attributes.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (Micrus Deltapaq 10 Cerecyte Microcoil System) |
|---|---|
| Intended Use is equivalent to predicate. | The Micrus Deltapaq 10 Cerecyte Microcoil System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial/venous embolizations in peripheral vasculature, which is equivalent to the predicate. |
| Design is equivalent to predicate. | The device has shown substantial equivalence in design to the Micrus Cerecyte Microcoil System. It consists of an embolic coil attached to a Device Positioning Unit. |
| Material of Construction is equivalent to predicate. | The device has shown substantial equivalence in material of construction to the Micrus Cerecyte Microcoil System. |
| Implant Dimensions (wire, coil, pitch, stiffness) are equivalent. | The device has shown substantial equivalence in implant dimensions, including wire dimensions, coil dimensions, coil pitch, and coil stiffness, to the Micrus Cerecyte Microcoil System. |
| Packaging, Method & Material of Construction, Sterilization are equivalent. | The Deltapaq 10 Cerecyte microcoils use the same packaging, method and material of construction, and sterilization method as its predicate. |
| Fundamental Technology has not been altered. | The modification (resulting in the Deltapaq 10 Cerecyte system from the Cerecyte system) has not altered the fundamental technology of the sponsor's predicate device. |
| Safety and Effectiveness is equivalent to predicate. | Based on design, materials, function, intended use, comparison with currently marketed devices, and non-clinical testing, the device is concluded to be substantially equivalent in safety and effectiveness to the predicate device. |
Study Details (as inferable from a 510(k) for a physical device)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of comparing algorithm performance. For a physical device like this, testing typically involves bench testing (e.g., mechanical properties, deployment, embolization effectiveness in models) rather than a clinical "test set" of patient data for diagnostic accuracy. The document mentions "non-clinical testing performed by Micrus Endovascular Corporation" but does not detail sample sizes for these tests.
- Data Provenance: The "non-clinical testing" would have been conducted by the manufacturer, Micrus Endovascular Corporation. It's retrospective in the sense that the testing was completed before the 510(k) submission. No country of origin for data (like patient studies) is provided as it's not a diagnostic AI device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As this is a physical medical device (microcoil) and not a diagnostic imaging AI, there isn't a "ground truth" established by human experts on a medical image test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence for a physical device would be based on engineering specifications, material science, and performance in bench models, judged against the predicate device's established performance or regulatory standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable for a physical device compliance demonstration.
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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:
- No. This type of study is specifically for diagnostic AI/CAD systems that assist human readers. The Micrus Deltapaq 10 Cerecyte Microcoil System is a therapeutic device for embolization, not a diagnostic tool requiring human interpretation improvement.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This question is also specific to AI/CAD algorithms. The microcoil is a physical medical implant, not a standalone AI algorithm. Its performance is inherent to its physical properties and how it's used by a clinician.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device, "ground truth" for substantial equivalence would primarily be:
- Engineering Specifications: Confirmation that the new device meets the same design, material, and dimensional specifications as the predicate device.
- Bench Testing Results: Data from physical tests (e.g., tensile strength, flexibility, deployment characteristics, embolization effectiveness in a simulated model) showing comparable performance to the predicate.
- Intended Use Alignment: Verification that the proposed indications for use align exactly with the predicate device.
- For this type of device, "ground truth" for substantial equivalence would primarily be:
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The sample size for the training set:
- N/A. This device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- N/A. As there is no training set, this is not applicable.
In summary, the K080437 submission for the Micrus Deltapaq 10 Cerecyte Microcoil System is a typical 510(k) for a modified physical medical device. It focuses on demonstrating "substantial equivalence" to a predicate device (Micrus Cerecyte Microcoil, K033813) by showing that the new device shares the same intended use, fundamental technology, design, materials, and manufacturing processes, and performs comparably in non-clinical testing. The framework of acceptance criteria and studies for AI/CAD devices (e.g., test sets, ground truth by experts, MRMC studies) does not apply to this type of submission.
§ 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).