(30 days)
The Roadrunner UniGlide Hydrophilic Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
The Roadrunner UniGlide Hydrophilic Wire Guide is constructed of a nitinol mandril with a jacket made of polyurethane with tungsten, and is hydrophilically coated. These wire guides are constructed with a shaft diameter of either 0.018 inch. 0.025 inch. 0.035 inch. They are manufactured in 80 cm, 150 cm, and 180 cm lengths and have a tapered, flexible tip. The 0.025 inch, 0.035 inch, and 0.038 inch versions of the Roadrunner UniGlide Hydrophilic Wire Guide are available in both standard and stiff configurations, while the 0.018 inch Roadrunner UniGlide Hydrophilic Wire Guide is available in the standard configuration only. The standard configurations have a 14 cm long tapered, flexible distal tip portion, whereas the stiff configurations have a 20 cm long tapered, flexible distal tip portion. The tip is manufactured in both straight and angled configurations. A torque device is supplied with the Roadrunner UniGlide Hydrophilic Wire Guide. The torque device is intended for use in complex diagnostic and interventional procedures and is designed for torque control.
The provided text describes a 510(k) premarket notification for the COOK INCORPORATED Roadrunner UniGlide Hydrophilic Wire Guide. This document focuses on demonstrating substantial equivalence to predicate devices and the physical performance of the wire guide itself, rather than the performance of an AI/ML powered device.
Therefore, many of the requested categories related to AI/ML device performance or clinical studies are not applicable to this 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
| Acceptance Criteria (Test) | Reported Device Performance (Summary) |
|---|---|
| Tensile Test | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Tip Stiffness | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Fracture Test | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Flexing Test | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Torque Testing | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Lubricity Test | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Biocompatibility Testing | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Bioburden Testing | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| Endotoxin Testing | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
| EtO Residual Testing | Results provide reasonable assurance of conformance to requirements for use as a wire guide. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the physical and material tests. It also does not provide information on data provenance (country of origin, retrospective/prospective), as these are laboratory/bench tests, not clinical data sets.
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 tests performed are engineering/material science tests, not clinical interpretations requiring expert consensus or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies involving reader interpretations, not for physical device testing.
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 document pertains to a physical medical device (wire guide) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device or algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these tests is based on established engineering and material science standards for medical devices, which dictate acceptable physical and chemical properties (e.g., tensile strength, lubrication efficiency, biocompatibility limits). It is not derived from clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
§ 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.