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.

AI/ML Overview

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.

Summary

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January 5, 2018

Cook Incorporated Ms. Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402

Re: K171948

Trade/Device Name: Roadrunner Extra Support Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: December 6, 2017 Received: December 7, 2017

Dear Ms. Allman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ms. Jennifer Allman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171948

Device Name

Roadrunner® Extra Support Wire Guide

Indications for Use (Describe)

The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitted By:	Jennifer L. Allman
	Cook Incorporated
	750 Daniels Way
	P.O. Box 489
	Bloomington, IN 47402
	Phone: (812) 335-3575 x104280
	Fax: (812) 332-0281
	Date Prepared: June 28, 2016

Device:

Trade Name:	Roadrunner® Extra Support Wire Guide
Common Name:	Wire, Guide, Catheter
Classification Name:	Catheter guide wireDQX (21 CFR §870.1330)

Indications for Use:

The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

Predicate Device:

The predicate Roadrunner™ RLTF Wire Guide (K920824) is available in a 180 cm length and outer diameters of 0.014, 0.016, and 0.018 inches and utilizes identical materials as compared to the subject device. The flexible tip portion of the predicate device is formed into an angled configuration. The predicate device is intended for use in directing a percutaneous catheter into the cardiovascular system.

Comparison to Predicate Device:

The Roadrunner® Extra Support Wire Guide is identical in intended use, fundamental technological characteristics, principle of operation, and materials to the predicate device, Roadrunner™ RLTF Wire Guide (K920824). The only difference is an additional length.

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Device Description:

The Roadrunner® Extra Support Wire Guide is a packaged, sterile device intended for single use.

There are no prior submissions for the subject device.

Discussion of Risk Mitigation Activities:

The following tests were performed to demonstrate that the Roadrunner® Extra Support Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence:

. Fracture Testing – Testing was performed in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
. Tensile Testing - Testing was performed in accordance with Annex H of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
. Flex Testing – Testing was performed in accordance with Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
. Radiopacity Testing - Radiopacity testing was performed in accordance with the qualitative evaluation described in ASTM F640-12.
. Torque Strength Testing – Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Dimensional Analysis Testing - Testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.

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. Rotational Response (Torqueability) Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Surface Analysis Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Corrosion Testing - Testing demonstrated, when tested in accordance with Annex B of BS EN ISO 11070:2014, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
. Catheter Compatibility Testing - Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
I Flex Testing on Aged Devices – Flex testing was repeated on aged devices in accordance with Section 8.5 and Annex B of BS EN ISO 11070:2014. The predetermined acceptance criteria were met.

Conclusion:

The results of the risk mitigation activities support a conclusion that the Roadrunner® Extra Support Wire Guide is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.