(28 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 of 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 and 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 detached from the delivery pusher in a serial manner until the aneurysm is occluded.
The provided text describes a 510(k) premarket notification for a medical device called the Optima Coil System (OptiBlock Line Extension). This submission focuses on demonstrating substantial equivalence to a predicate device (Optima Coil System, K223386) for which it is a modification or line extension.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection, Dimensional Inspection, and Resistance Check | The test samples shall meet established test acceptance criteria for visual physical damage, secondary diameter and length, and resistance. | Pass |
| Simulated Use | The test samples shall be prepared in accordance with the instructions for use and meet established test acceptance criteria for device performance in a clinically relevant model. | Pass |
2. Sample size used for the test set and the data provenance:
The document explicitly states "The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence...". It mentions "test samples" but does not specify the sample size for either of the tests performed. The data provenance is from bench testing for a medical device line extension, not involving human subjects or clinical data in this submission. Therefore, country of origin is not applicable in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the studies are non-clinical bench tests, the "ground truth" would be established by engineering specifications and objective measurements rather than expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is generally not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases.
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 information is not applicable as the described device is a neurovascular embolization coil system, not an AI software or a device that assists human readers in interpreting medical images. There is no mention of AI in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable for the same reasons as point 5. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
For the "Visual Inspection, Dimensional Inspection, and Resistance Check," the ground truth would be engineering specifications and manufacturing tolerances. For "Simulated Use," the ground truth would be pre-defined performance criteria within a clinically relevant model, also based on engineering and functional specifications for the device's intended operation. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these non-clinical tests.
8. The sample size for the training set:
This information is not provided and is not applicable given that this is not an AI/machine learning device. The concepts of "training set" and "ground truth for the training set" are relevant to machine learning model development, not for a physical medical device.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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).