(99 days)
The AZUR PURE 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 PURE Peripheral Coil System, Pushable 18 & 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AZUR PURE Peripheral Coil System, Pushable 18 & 35:
Based on the provided K122543 510(k) summary, this document describes a medical device (a vascular embolization coil) and its submission for FDA clearance. The information provided outlines the verification and validation tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance in a diagnostic or AI-assisted context.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of device and submission. The provided information focuses on engineering and biocompatibility testing.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Established criteria (details not provided) | Met established criteria |
| Dimensional Characteristics | Established criteria (details not provided) | Met established criteria |
| Tensile Strength | Established criteria (details not provided) | Met established criteria |
| Advancement Force | Established criteria (details not provided) | Met established criteria |
| FTIR | Established criteria (details not provided) | Met established criteria |
| HydroStability | Established criteria (details not provided) | Met established criteria |
| MRI Compatibility | Established criteria (details not provided) | Met established criteria |
| Electrical Conductivity | Established criteria (details not provided) | Met established criteria |
| Packaging Validation | Established criteria (details not provided) | Met established criteria |
| Sterilization Validation | Established criteria (details not provided) | Met established criteria |
| Shelf Life | Established criteria (details not provided) | Met established criteria |
| Biocompatibility | Established criteria (details not provided) | Met established criteria |
| Acute & Chronic Animal Testing | Established criteria (details not provided) | Met established criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test beyond "Met established criteria." The tests are primarily engineering and benchtop tests, along with animal testing.
- Data Provenance: The tests are conducted by the manufacturer, MicroVention, Inc., in Tustin, California, USA, as part of their 510(k) submission. This is not clinical data but verification and validation testing for device safety and performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: For this type of device (vascular embolization coil) and the tests described (engineering, biocompatibility, animal testing), the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not relevant. The "ground truth" for these tests would be defined by the pre-established engineering specifications, regulatory standards, and animal study protocols.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic tasks involving human readers. For the engineering and animal tests described, the results are typically objectively measured and compared against predefined performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: An MRMC comparative effectiveness study is not mentioned. Such studies are typically performed for diagnostic devices (e.g., AI in radiology) to evaluate reader performance with and without AI assistance. This device is a therapeutic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is a physical medical implant, not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.
7. The Type of Ground Truth Used
- For the engineering tests (Dimensional Characteristics, Tensile Strength, etc.), the "ground truth" is based on pre-defined engineering specifications, performance standards, and material science properties.
- For Biocompatibility, the "ground truth" is established through recognized biological safety standards and in vitro/in vivo testing protocols.
- For Acute & Chronic Animal Testing, the "ground truth" is established through histopathological analysis, observation of physiological responses, and adverse event reporting in animal models, as defined by the study protocol.
8. The Sample Size for the Training Set
- Not Applicable: This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, there is no training set for this device.
§ 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).