(190 days)
The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
The Roadrunner® Extra Support Wire Guide is manufactured in an outer diameter of 0.014 inches and lengths of 180 and 300 centimeters. The flexible tip portion of the subject device is formed into an angled configuration. The Roadrunner® Extra Support Wire Guide consists of a coated mandril with a coil covering the tip of the mandril. A pin vise is supplied with the subject device.
The Roadrunner® Extra Support Wire Guide is a packaged, sterile device intended for single use.
This document describes the Roadrunner® Extra Support Wire Guide (K171948) and its substantial equivalence to a predicate device. The information provided outlines several tests performed to demonstrate the device meets acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Standard/Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fracture Testing | BS EN ISO 11070:2014, Annex F | Pre-determined acceptance criteria were met. | The pre-determined acceptance criteria were met. |
| Tensile Testing | BS EN ISO 11070:2014, Annex H | Pre-determined acceptance criteria were met. | The pre-determined acceptance criteria were met. |
| Flex Testing | BS EN ISO 11070:2014, Annex G | Pre-determined acceptance criteria were met. | The pre-determined acceptance criteria were met. |
| Radiopacity Testing | ASTM F640-12 | Qualitative evaluation demonstrating radiopacity. | Radiopacity testing was performed in accordance with the qualitative evaluation. |
| Torque Strength Testing | FDA Coronary and Cerebrovascular Guidewire Guidance (1995) | Characterization of torque strength to ensure suitability. | Characterization testing was performed. |
| Dimensional Analysis Testing | FDA Coronary and Cerebrovascular Guidewire Guidance (1995) | Pre-determined acceptance criteria were met. | The predetermined acceptance criteria were met. |
| Rotational Response (Torqueability) Testing | FDA Coronary and Cerebrovascular Guidewire Guidance (1995) | Characterization of rotational response/torqueability. | Characterization testing was performed. |
| Surface Analysis Testing | FDA Coronary and Cerebrovascular Guidewire Guidance (1995) | Characterization of surface properties. | Characterization testing was performed. |
| Corrosion Testing | BS EN ISO 11070:2014, Annex B | No signs of corrosion that would affect functional performance. | No signs of corrosion that would affect functional performance; pre-determined acceptance criteria were met. |
| Catheter Compatibility Testing | BS EN ISO 11070:2014 | Pre-determined acceptance criteria were met. | The pre-determined acceptance criteria were met. |
| Flex Testing on Aged Devices | BS EN ISO 11070:2014, Section 8.5 and Annex B | Pre-determined acceptance criteria were met for devices after aging. | The predetermined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test. The provenance of the data is retrospective, as the tests were performed on the device after manufacturing to demonstrate conformance to standards. The country of origin of the data is not specified, but the manufacturing company (Cook Incorporated) is based in Bloomington, Indiana, USA, suggesting the testing was likely conducted in the US or by US-affiliated entities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a medical device (guidewire) submission, not an AI/software submission. Therefore, the concept of "experts" establishing a "ground truth" for the test set in the context of medical imaging or diagnostic algorithms does not apply. The ground truth for device performance is established through adherence to recognized international and FDA standards, and engineering specifications.
4. Adjudication method for the test set
Not applicable. This is a medical device submission, not an AI/software submission that would involve adjudication of interpretations. Device performance is determined by meeting pre-defined quantitative and qualitative engineering and material science criteria.
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 is a medical device submission; no AI component or human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device submission; no standalone algorithm performance is discussed.
7. The type of ground truth used
The "ground truth" for this medical device is the adherence to established international and FDA performance standards and the stated engineering specifications. These standards (e.g., BS EN ISO 11070, ASTM F640, FDA Guidances) define the acceptable limits and characteristics for the device's physical and mechanical properties.
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI/software submission. There is no concept of a "training set" in the context of mechanical device testing for substantial equivalence.
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.