(187 days)
The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.
Hilal Embolization MicroCoils™ are manufactured from coiled platinum wire with equidistantly spaced nylon fibers and are available in straight, single-curl, and multiplecurl configurations. The Hilal coils are designed to be delivered by microcatheters with a minimum end hole diameter of 0.018 inch. The extended embolus lengths of the finished device range from 0.5 to 6.0 centimeters. The coiled embolus diameters range from 2 to 10 millimeters. The Hilal coils are loaded in a straight configuration into a loading cartridge. A loading stylet is also provided for loading this coil into the delivery catheter.
The provided text describes the Hilal Embolization MicroCoils™ and its substantial equivalence to a predicate device, the Cook Retracta® Detachable Embolization Coil. The information required for a detailed study description is somewhat limited in this document, as it summarizes performance data rather than providing a full study report.
Based on the available text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Wire Tensile Testing: Peak load value greater than or equal to minimum tensile strength requirements. | The predetermined acceptance criteria were met. |
| Animal Testing (Acute Performance): No evidence of arterial damage or coil migration in a porcine model. | The predetermined acceptance criteria were met (for straight and single curl Hilal coils). |
Note: For "Coil Tensile Testing," the document only states that testing characterized the uniaxial tensile strength, but does not explicitly mention acceptance criteria or if it was met.
2. Sample size used for the test set and the data provenance:
- Wire Tensile Testing: Not specified.
- Coil Tensile Testing: Not specified.
- Animal Testing: Not specified, but performed using a "porcine model." The provenance is a laboratory setting.
- Leveraged Testing (Nester® and Tornado® Embolization Coils): Sample sizes for bench, MRI, and animal testing are not specified.
The data provenance is likely prospective for the tests performed directly on the Hilal Embolization MicroCoils™ as it's part of a premarket notification to establish substantial equivalence.
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. The animal testing results would likely be evaluated by veterinary or medical experts, but their number and qualifications are not disclosed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 is not applicable. The device is an embolization microcoil, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Wire Tensile Testing & Coil Tensile Testing: Mechanical measurements against engineering specifications.
- Animal Testing: Outcomes data based on direct observation of arterial damage or coil migration in a porcine model. This would be observed and assessed by researchers/veterinarians.
8. The sample size for the training set:
There is no training set mentioned for this device. The tests described are performance verification tests. The device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
As there is no training set, this question is not applicable.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).