(48 days)
Used for peripheral arterial and venous vessel embolization procedures.
The MReye® Embolization Coil is supplied sterile and is intended for one time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has wire diameters of 0.025, 0.035, and 0.038 inches. It is available in curled and straight shapes. The emboli size range is 0 mm (straight) to 15 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved by a wire guide (sold separately) pushing the coil out of the catheter.
This document describes a 510(k) premarket notification for the MReye® Embolization Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance criteria through clinical studies or detailed algorithm evaluations.
Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies assessing AI/ML device performance or clinical effectiveness studies for novel devices, is not present in this 510(k) submission.
Here's an explanation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with specified quantitative thresholds for performance metrics. Instead, it lists the types of tests performed to ensure reliable design and performance, and generally states that the results provide "reasonable assurance" of conformance.
| Test Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Delivery Friction Testing | (Implied: Acceptable friction for deployment) | Not specified beyond "subjected to tests" |
| Coil Connection Testing | (Implied: Secure connection) | Not specified beyond "subjected to tests" |
| Coil Deformation Testing | (Implied: Maintains shape as intended) | Not specified beyond "subjected to tests" |
| Wire Tensile Strength | (Implied: Sufficient strength to avoid breakage) | Not specified beyond "subjected to tests" |
| Fiber Pull Out Testing | (Implied: Fibers remain securely attached) | Not specified beyond "subjected to tests" |
| Magnetic Resonance (MR) Testing | (Implied: MR compatibility/safety) | Not specified beyond "subjected to tests" |
| Biocompatibility Testing | (Implied: Biocompatible) | Not specified beyond "subjected to tests" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for a medical device (embolization coil), not an AI/ML diagnostic or prognostic algorithm that uses test sets with patient data. The "tests" mentioned are engineering and material compatibility tests, not clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is relevant for studies where human expert review establishes a "ground truth" for comparison, typically in AI/ML performance evaluations or clinical trials. This 510(k) focuses on the physical and material characteristics of the coil.
4. Adjudication Method
Not applicable for the same reasons as points 2 and 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. This type of study is designed to assess how human readers' performance changes with AI assistance, which is not applicable to a physical medical device like an embolization coil.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study evaluating an algorithm's performance was not performed. This device is a physical embolization coil, not a software algorithm.
7. Type of Ground Truth Used
Not applicable. The "ground truth" concept (e.g., pathology, outcomes data, expert consensus) is typically used in the context of diagnostic or prognostic evaluations, often involving imaging or other patient data. The tests performed for this device relate to its physical and material properties.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
§ 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).