(30 days)
The Azur Peripheral HydroCoil Endovascular Embolization 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 HydroCoil Endovascular Embolization System- Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the detachment controller. The detachment controller is activated by the user and this detaches the coil. The Azur coils are designed for use with the Azur Detachment Controller, specifically designed for coil detachment.
Here's an analysis of the provided text regarding the Azur Peripheral HydroCoil Endovascular Embolization System - Detachable 35, specifically focusing on acceptance criteria and study details.
Based on the provided 510(k) summary, this submission is for a medical device (vascular embolization coil), not a software or AI-based diagnostic tool. Therefore, many of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and submission.
The "study" described is a bench testing verification, which is typical for physical medical devices to demonstrate safety and performance against established criteria, typically in a laboratory setting. There is no mention of clinical trials, patient data, or expert consensus being used for this specific 510(k) submission.
Here's the breakdown of the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Visual inspection | Met established criteria |
| Dimensional inspection | Met established criteria |
| Simulated use testing | Met established criteria |
| Reposition time | Met established criteria |
| Detachment test | Met established criteria |
| Advancement/Retraction test | Met established criteria |
| Detachment element tensile test | Met established criteria |
| Coil initial tension test | Met established criteria |
| Coil tensile test | Met established criteria |
| Gel expansion | Met established criteria |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided text for each specific bench test. The phrase "Met established criteria" implies that a sufficient number of tests were performed according to a pre-defined protocol.
- Data Provenance: The tests are "Bench Testing," implying a laboratory or engineering environment. There is no indication of country of origin for data or if it's retrospective/prospective, as it's not based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus or pathology, is not relevant for the bench testing of a physical medical device. The "ground truth" here is the engineering specifications and performance standards established for the device.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers/experts, which is not relevant for bench testing of a device's physical and functional properties.
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 physical embolization coil, not an AI software. No MRMC study was performed or is relevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a physical embolization coil, not an algorithm. No standalone performance evaluation for an algorithm was performed.
7. The type of ground truth used
- Engineering Specifications and Performance Standards: For bench testing, the "ground truth" is defined by pre-established engineering specifications, performance requirements, and established industry standards for vascular embolization coils. The device's performance is measured against these objective, quantifiable criteria.
8. The sample size for the training set
- Not Applicable. This pertains to machine learning models. This submission describes a physical device, not an AI system.
9. How the ground truth for the training set was established
- Not Applicable. This pertains to machine learning models.
§ 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).