The Roadrunner UniGlide Hydrophilic Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Device Description

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.

AI/ML Overview

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.

Summary

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COOK INCORPORATED Roadrunner UniGlide Hydrophilic Wire Guide Special 510(k) Premarket Notification

510(k) Summary

Submitted By:

FEB - 2 2011

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 December 23, 2010

Device:

Trade Name:	Roadrunner UniGlide Hydrophilic Wire Guide
Classification Name:	Wire, Guide, Catheter21 CFR §870.1330
Device Classification:	Class II
Product Code:	DQX
Classification Panel:	Cardiovascular Panel

Indications for Use:

The Roadrunner UniGlide Hydrophilic Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Predicate Devices:

The Roadrunner UniGlide Hydrophilic Wire Guide is identical to the Approach Hydro ST Wire Guide (K091385) in terms of intended use and similar to the Roadrunner Wire Guide (K92089) ) in terms of materials of construction and technological characteristics.

Device Description:

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Substantial Equivalence:

The Roadrunner UniGlide Hydrophilic Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the peripheral vascular system. Specifically, the identical indications for use and principles of operation and similar materials of construction and technological characteristics of the wire guide compared to the Approach Hydro ST and Roadrunner Wire Guides support a determination of substantial equivalence.

Test Data:

The Roadrunner UniGlide Hydrophilic Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

1. Tensile Test
1. Tip Stiffness
1. Fracture Test
1. Flexing Test
1. Torque Testing
1. Lubricity Test
1. Biocompatibility Testing
1. Bioburden Testing
1. Endotoxin Testing
1. EtO Residual Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cook, Inc. c/o Karen Bradburn 750 Daniels Way P.O. Box 489 Bloomington, IN 47402-0489

FEB - 2 201

Re: K110009

Trade/Device Name: Roadrunner UniGlide Hydrophilic Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 23, 2010 Received: January 3, 2011

Dear Ms. Bradburn:

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.

、

and the same of the same of the same of the same of the states of

1000 - 1000

・・・ 100 million and

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Page 2 - Ms. Karen Bradburn

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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COOK INCORPORATED Roadrunner UniGlide Hydrophilic Wire Guide Special 510(k) Premarket Notification

510(k) Number (if known):

Device Name: Roadrunner UniGlide Hydrophilic Wire Guide

Indications for Use: For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use -(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
	Division of Cardiovascular Devices
510(k) Number	16110009

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.