(194 days)
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.
This document is a 510(k) premarket notification for a medical device called the R350 Guidewire. The content focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria through a trial. As such, information regarding clinical study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is largely not applicable in the context of this 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the "results of the design verification and validation tests met the specified acceptance criteria" for a series of mechanical and biocompatibility tests. However, the specific quantitative acceptance criteria and the numerical reported device performance for each test are not provided in this summary. Only the types of tests conducted are listed.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Hydrophilic Coating Particulate | Passed |
| Hydrophilic Coating Delamination Inspection (after Fracture Test) | Passed |
| Fluoroscopy Visualization | Passed |
| Guidewire O.D. | Passed |
| Guidewire Length | Passed |
| Component Alignment | Passed |
| Interface with Other Devices | Passed |
| Torqueability | Passed |
| Torque | Passed |
| Flex | Passed |
| Fracture | Passed |
| Tip Deflection Force | Passed |
| Tip Load | Passed |
| Distal Solder Joint Tensile | Passed |
| Proximal Solder Joint Tensile | Passed |
| Corrosion | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, ASTM Hemolysis, Complement Activation, ASTM Platelet and Leukocyte Count Assay, Partial Thromboplastin Time, In Vivo Thrombogenicity) | Passed (per ISO 10993-1) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the listed tests. The document only mentions "device samples."
- Data Provenance: Not specified. Given that these are design verification and validation tests, they are likely performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc. in Minneapolis, USA) during device development, which would make them prospective tests, but this is an inference.
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)
Not Applicable. The ground truth for these engineering and biocompatibility tests is established by standardized testing methods and quantifiable metrics, not by expert consensus in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As these are performance tests against engineering specifications and international standards, there is no adjudication by human experts in the way clinical studies are adjudicated. Results are determined by test equipment and adherence to predefined protocols.
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
Not Applicable. This device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is based on:
- Engineering Specifications: For mechanical tests like guidewire dimensions, torque, flex, fracture, etc.
- International Standards: Specifically, ISO 10993-1 for biocompatibility tests.
8. The sample size for the training set
Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
§ 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.