(26 days)
The AZUR 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 CX Coil System - Detachable 18 Coils are made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths which have the gel on all the loops. The implant segment is then attached to the delivery 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).
Here's an analysis of the provided text regarding the Azur CX Coil System, focusing on the acceptance criteria and supporting studies.
Based on the provided text, the device is a Class II Vascular Embolization Device and the submission is a 510(k) premarket notification for a line extension. This means the primary goal of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, rather than proving novel effectiveness or efficacy through extensive clinical trials.
Therefore, the "acceptance criteria" and "studies" are primarily focused on bench testing to show that the new device performs similarly and safely to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Bench Testing) | Reported Device Performance |
|---|---|
| Simulated Use | Met established criteria |
| Detachment | Met established criteria |
| Advancement / Retraction Force | Met established criteria |
Note: The document states that the data demonstrates "technological similarity and equivalency" and that the device "is, in our opinion, substantially equivalent" to the predicate devices. The specific quantitative acceptance thresholds for "Met established criteria" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only mentions "Bench Testing" and does not provide details on the number of units tested for each criterion.
- Data Provenance: The studies are described as "Bench Testing," implying in-vitro, laboratory-based testing conducted by the manufacturer, MicroVention, Inc. (located in Tustin, California, U.S.A.). The data is prospective in the sense that MicroVention performed these tests for the submission, but they are not clinical studies on human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For a 510(k) submission based on bench testing for substantial equivalence, the "ground truth" is typically established by engineering specifications, validated test methods, and comparison against the performance of predicate devices. There is no mention of external human experts establishing ground truth for these bench tests in the provided document.
4. Adjudication Method for the Test Set
- Not Applicable. As the “studies” are in-vitro bench tests, there is no clinical data or expert review process that would require an adjudication method like those used for clinical trials or image interpretation. The testing results are likely evaluated against predetermined engineering specifications and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is a type of clinical study typically used to evaluate the diagnostic accuracy of a medical imaging device when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a vascular embolization device, and the provided document only discusses bench testing for substantial equivalence, not a clinical effectiveness study of diagnostic image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This device is a physical medical implant (a coil system for embolization), not an algorithm or AI software that would have a "standalone" performance. The "device" itself is the instrument being evaluated.
7. Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance. For the bench tests ("Simulated Use," "Detachment," "Advanccment / Retraction Force"), the "ground truth" or standard for acceptance would be based on:
8. Sample Size for the Training Set
- Not Applicable. This is not an AI or machine learning device that requires a "training set." The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (As above, no training set is relevant for this type of device submission.)
§ 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).