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510(k) Data Aggregation
(119 days)
For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
The Roadrunner® UniGlide™ Hydrophilic Wire Guide is a hydrophilically coated device constructed of a nitinol core wire with a polyurethane jacket. It is available in diameters ranging from 0.018 in. to 0.038 in. and lengths from 80 cm to 320 cm. The Roadrunner® UniGlide Hydrophilic Wire Guide is manufactured in both a standard shaft and a stiff shaft version. A torque device is supplied with the Roadrunner® UniGlide™ Hydrophilic Wire Guide. The torque device is designed for torque control and is intended for use in complex diagnostic and interventional procedures.
This submission details a 510(k) premarket notification for a modified medical device, the Roadrunner® UniGlide™ Hydrophilic Wire Guide. Since this is a premarket notification for a modified device seeking substantial equivalence to a predicate device, the acceptance criteria and study focus on demonstrating that the modifications do not alter the safety and effectiveness of the device compared to the previously cleared predicate.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Modified device lengths (260 cm and 320 cm) must maintain equivalent hydrated lubricity to the predicate device. | "This testing confirmed that the hydrated lubricity for the modified 260 cm and 320 cm wire guides is equivalent to the hydrated lubricity demonstrated by the predicate wire guides." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the "Hydrated Lubricity Test." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given that the testing was performed to demonstrate substantial equivalence for a manufactured device, it's highly likely this was a prospective test conducted by the manufacturer, Cook Incorporated, in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of submission for a physical medical device (a guide wire) does not involve "experts" establishing ground truth in the sense of medical diagnosis or image interpretation. The ground truth for device performance is based on direct physical testing against engineering specifications and comparisons to the predicate device's established performance. Therefore, this question is not applicable in the context of this document.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving subjective assessments, such as image interpretation, where disagreements between experts need to be resolved. For objective physical device testing like lubricity, an adjudication method is not applicable. The results are typically numerical measurements compared against predefined thresholds or the predicate's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is used to evaluate the impact of a diagnostic tool or AI on human readers' performance (e.g., radiologists interpreting images). This submission is for a physical medical device (a guide wire) and does not involve human readers interpreting data in this context. Therefore, this question is not applicable.
6. Standalone Performance Study
Yes, in a sense. The "Hydrated Lubricity Test" represents a standalone performance evaluation of the modified device itself against a specific physical property (lubricity). While the primary purpose was to demonstrate equivalence to the predicate, the test assesses the device's intrinsic performance attribute. The performance is reported as "equivalent" rather than absolute values.
7. Type of Ground Truth Used
The ground truth used is based on engineering specifications and comparative performance data derived from the predicate device. For the "Hydrated Lubricity Test," the ground truth for "equivalent" performance is the established hydrated lubricity of the predicate device (K110009). The new lengths of the device must meet or perform similarly to this established benchmark.
8. Sample Size for the Training Set
This submission does not involve a "training set" in the context of machine learning or AI models. This is a physical medical device with a modification, and its performance is evaluated through physical and functional testing, not through training data for an algorithm. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established
As stated above, there is no "training set" in this context. Therefore, this question is not applicable. The ground truth for the performance evaluation (lubricity) was established by the predicate device's known performance.
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(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.
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