(194 days)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System 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 Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
The provided document is a 510(k) Pre-Market Notification for the Optima Coil System. It focuses on demonstrating substantial equivalence to a predicate device through performance bench testing, animal testing, biocompatibility studies, sterilization validation, and shelf-life/packaging testing. It does not contain information about studies involving human readers, AI assistance, or expert-established ground truth which are typically associated with performance evaluations of diagnostic or AI-driven medical devices.
Therefore, I cannot provide information for points 1-9 as they are not applicable to the content of this document. The document describes a medical device (neurovascular embolization coil system) and its mechanical, material, and biological performance, not an AI or diagnostic tool.
The "device performance" mentioned in the document refers to how the physical device (the coil system) performs in various mechanical and biological tests, not its accuracy in diagnosing or interpreting medical conditions.
Here's an explanation of why the requested information isn't present in the document:
- Acceptance Criteria and Reported Device Performance (Table): The document lists "Test Method Summary" and "Results" for various tests (e.g., Corrosion Resistance, MRI Compatibility, Biocompatibility). The acceptance criterion for all these tests is implicitly "All test samples passed testing", which is consistently reported as the result. However, the exact numerical acceptance ranges or thresholds are not detailed for each specific test, only the pass/fail outcome.
- Sample Size (Test Set) and Data Provenance: Sample sizes are not explicitly stated for individual bench tests. For animal testing, it mentions "acute porcine model" but not the number of animals. Biocompatibility studies specify "3 Rabbits" for a 4-week implantation and "4 Rabbits" for a 13-week implantation. No data provenance in terms of country of origin is mentioned. All studies appear to be prospective lab/animal studies.
- Number of Experts and Qualifications (Ground Truth): Not applicable. This document does not describe studies that require human experts to establish ground truth, as it's not a diagnostic or AI-driven device.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance: The "device performance" shown is standalone performance of the physical device via bench and animal testing.
- Type of Ground Truth: For the mechanical and biological tests, the "ground truth" is defined by established scientific and engineering principles, international standards (e.g., ISO, ASTM), and the requirements for a safe and effective medical device. For example, for biocompatibility, the ground truth is that the device should not be cytotoxic, sensitizing, irritant, etc., as determined by standardized biological assays.
- Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
- Ground Truth for Training Set: Not applicable.
In summary, the provided text details the regulatory submission for a physical medical device. The types of evaluations described are standard for such devices (mechanical, material, biological safety), and do not involve AI performance metrics or human reader studies.
§ 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).