(60 days)
The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.
The Meridian Guidewire is a stainless steel guidewire with a radiopaque, distal coil. The distal portion of the guidewire is hydrophilically coated. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
This 510(k) summary describes a guidewire, which generally undergo non-clinical (bench) testing rather than clinical studies with human participants. Therefore, many of the typical clinical study parameters (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable in the same way they would be for AI/ML-based diagnostic devices.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The core of this submission is demonstrating substantial equivalence to a predicate device, not necessarily meeting specific numerical performance metrics in a clinical study. The "acceptance criteria" are implied by the similarity to the predicate and the successful completion of non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Safe for use in the body. | Biocompatibility testing performed. |
| Bench Testing Performance: Meets functional and safety requirements through laboratory tests. | Extensive bench testing performed. |
| In vitro Design Validation: Design is suitable for intended use in a controlled environment. | In vitro design validation study performed. |
| Shelf-life: Maintains integrity and functionality over time. | Shelf-life testing performed. |
| Sterility & Safety (Bioburden, Pyrogen, EtO residuals): Meets sterilization and safety standards. | Assessment of bioburden, pyrogen, EtO residuals, and sterility performed. |
| Similar Technological Characteristics to Predicate: Materials, dimensions, accessories, and packaging are comparable. | Materials and dimensions similar to predicate. Packaging materials and accessories identical to predicate. |
| Identical Principles of Operation: Operates in the same fundamental way as the predicate. | Identical principles of operation. |
| Identical Indications for Use: Used for the same medical purposes as the predicate. | Identical indications for use. |
Study Details
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" would be the guidewire itself and its components, subjected to various bench and in vitro tests. The provenance is the manufacturer (Micro Therapeutics dba ev3 Neurovascular, Irvine, CA, USA). All testing would have been conducted in a controlled laboratory environment.
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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): Not applicable for this type of device and submission. "Ground truth" for guidewires is typically established by engineering specifications, material standards, and validated testing protocols, not expert clinical consensus on individual cases.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against engineering standards and established testing methodologies.
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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: Not applicable. This document describes a medical device (guidewire), not an AI/ML diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a guidewire, the "ground truth" for performance is based on adherence to design specifications, material properties, biomechanical test results (e.g., tensile strength, torqueability, lubricity), sterility standards, and biocompatibility requirements, all of which are scientifically measured and compared against established benchmarks or the predicate device.
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The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.
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How the ground truth for the training set was established: Not applicable.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.