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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, consists of an implantable 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.

The subject of this Special 510(k) is the addition of a platinum overcoil to the AZUR PURE Pushable 18 device. The purpose is to improve tracking performance of the coil implant during delivery.

With the exception of the modification to add the platinum overcoil, the modified devices are identical to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AZUR PURE Peripheral Coil System, Pushable 18:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes pre-clinical bench testing. It does not explicitly state the numerical sample size for each test. However, it indicates these are bench tests, which are performed in a controlled laboratory setting.

• Test Set Sample Size: Not explicitly stated as a concrete number of devices for each test, but implied to be sufficient for demonstrating compliance with acceptance criteria.
• Data Provenance: This is prospective bench test data generated in a laboratory setting by MicroVention, Inc. There is no mention of country of origin for the data beyond the company's US location (Tustin, California).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided information. The tests conducted are bench tests evaluating physical and mechanical properties of the device. Ground truth is established by objective measurements against predefined engineering specifications (the acceptance criteria), not by expert consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

This section is not applicable. Since the tests are objective bench tests with quantifiable acceptance criteria, there is no need for an adjudication method by human experts. The results are either a pass or a fail based on measurements.

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 section is not applicable. The device is an embolization coil, a physical medical device, not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As mentioned above, the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and bench tests is objective engineering specifications and physical measurements. For example, the advancement force is measured against a threshold of "less than 0.3 lbf," and tensile strength against a "0.05 lbf minimum."

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. As stated, there is no "training set" for this type of device.

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