(115 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 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.
The provided document describes a 510(k) submission for a design modification to the AZUR PURE Peripheral Coil System, specifically the addition of an "Overcoil." This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove device performance against specific acceptance criteria.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is not applicable or available in this summary. The submission focuses on verifying that the modified device's performance is equivalent to the predicate device through non-clinical testing.
Here's a breakdown of why this information is not provided in the document:
- Nature of 510(k) for design modification: Special 510(k)s for design modifications, like this one, aim to demonstrate that the changes do not raise new questions of safety and effectiveness. This is typically achieved by showing that the modified device performs similarly to a legally marketed predicate device through engineering tests and comparisons, rather than de novo clinical trials.
- Focus on equivalence: The document explicitly states, "The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal." This is the core argument of the submission.
Analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Verification & Validation Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Same as predicate | Met same criteria as predicate |
| Advancement Force | Same as predicate | Met same criteria as predicate |
| Tensile Strength at glue joint | Same as predicate | Met same criteria as predicate |
| Expansion Characteristics | Same as predicate | Met same criteria as predicate |
Explanation: The "acceptance criteria" for the modified device were to "Met same criteria as predicate." The actual quantitative criteria for the predicate device themselves are NOT provided in this document. The "reported device performance" is simply that the modified device met these (unspecified) criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. This would typically be non-clinical, in-vitro testing rather than human data.
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)
- Number of experts: Not applicable. These are engineering/performance tests, not human-read clinical evaluations.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This refers to consensus among human readers for clinical ground truth, which is not relevant here.
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
- MRMC study: No, an MRMC study was not done. This is a non-clinical device modification submission, not an AI efficacy study.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This device is not an algorithm, but a physical medical device. The "standalone" performance here would refer to the device's physical and mechanical capabilities. The Verification & Validation test summary (Simulated Use, Advancement Force, Tensile Strength, Expansion Characteristics) can be considered "standalone" in this context, demonstrating the device's functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" for these engineering tests would be derived from established engineering specifications, mechanical testing standards, and the validated performance characteristics of the predicate device. For example, a tensile strength test would have a pre-defined pass/fail threshold based on the predicate.
8. The sample size for the training set
- Sample size: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable.
§ 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).