(27 days)
The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
The AZUR Peripheral Coil System - 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 sponsor, MicroVention, Inc., submitted an amendment to their 510(k) for the AZUR Peripheral Coil System - Detachable 18. This device is a vascular embolization device intended to reduce or block blood flow in peripheral vasculature. The device has the same indications for use as predicate devices, MicroVention AZUR Detachable 18 HydroCoil (K090168) and AZUR Pushable 35 (K071939). In conclusion, the AZUR Peripheral Coil System - Detachable 18 is substantially equivalent to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Measurement | Met established criteria | Met established criteria |
| Tracking | Met established criteria | Met established criteria |
| Repositioning / Deployment | Met established criteria | Met established criteria |
| Detachment Test | Met established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The provided text details bench testing, not clinical studies with patients.
3. 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. Ground truth for bench testing is typically based on engineering specifications and measurement standards, not expert clinical interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This information is relevant for clinical studies with subjective assessments, not for bench testing.
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
Not applicable. This device is a vascular embolization device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the bench testing was based on "established criteria," which likely refers to engineering specifications, design parameters, and established industry standards for dimensional accuracy, device tracking, repositioning/deployment functionality, and detachment effectiveness.
8. The sample size for the training set
Not applicable. This information is not relevant for the type of bench testing described.
9. How the ground truth for the training set was established
Not applicable. This information is not relevant for the type of bench testing described.
§ 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).