The Mandril Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a stainless steel or nitinol mandril design with a stainless steel, palladium, or platinum distal spring coil anchored over the distal portion of the mandril. The Mandril Wire Guide is available with outside diameters ranging from 0.015 inches to 0.018 inches and lengths ranging from 25 centimeters (cm) to 180 cm. The tip portion of the subject device is either straight or angled. The Mandril Wire Guide is a packaged, sterile device intended for single patient use.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Cook Incorporated Mandril Wire Guide (K171997). The document outlines the device description, intended use, comparison to a predicate device, and the technological characteristics demonstrated through various tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
Biocompatibility Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Corrosion Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Flexing Test	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Fracture Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Tensile Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Tip Flexibility Testing (Tip Deflection)	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Torqueability Testing (Rotational Response)	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Torque Strength Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Radiopacity Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Surface Examination	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Dimensional Measurement Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Catheter Compatibility Testing	(Not explicitly stated as "met," but implied)	Performed in accordance with FDA guidance.
Acute Performance Evaluation (Animal Model)	Pre-determined acceptance criteria for all performance parameters were met	All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for any of the individual tests. It states that "All test articles evaluated" for the Acute Performance Evaluation met the criteria, implying all samples used in that test.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective for most tests. However, the Acute Performance Evaluation was conducted in an animal model, which is a prospective study design to simulate clinical use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and performance tests on the device itself, not assessments requiring human expert interpretation for "ground truth" in the way a diagnostic AI might.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The tests described are objective measurements of the device's physical properties and performance against pre-defined criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic devices that involve human interpretation of images or data, often comparing AI-assisted performance to unassisted human performance. The Mandril Wire Guide is a physical medical device (guidewire), and its evaluation focuses on its mechanical, material, and functional properties.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The Mandril Wire Guide is a physical medical device, not an algorithm or software that operates in a standalone manner. Its performance is inherent to its physical design and construction.

7. The Type of Ground Truth Used

For the various engineering and performance tests (biocompatibility, corrosion, flexing, fracture, tensile, tip flexibility, torqueability, torque strength, radiopacity, surface examination, dimensional measurement, catheter compatibility), the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and FDA guidance documents, along with an "approved study protocol" for dimensional measurements. These standards and protocols define the expected performance characteristics.

For the Acute Performance Evaluation, the ground truth is based on the device's performance in an animal model under simulated clinical conditions, against pre-determined acceptance criteria for various performance parameters. This is effectively an in-vivo performance assessment.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. A "training set" refers to data used to train machine learning algorithms. The Mandril Wire Guide is a physical device, and its development and testing do not involve machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in a larger font and 'ADMINISTRATION' in a smaller font, both in blue.

March 30, 2018

Cook Incorporated Ms. Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K171997

Trade/Device Name: Mandril Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: February 23, 2018 Received: February 26, 2018

Dear Ms. Allman:

We have reviewed vour 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

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,

Nicole G. Ibrahim -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) K171997

Device Name Mandril Wire Guide

Indications for Use (Describe)

To facilitate the placement of devices during diagnostic or interventional procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font in the upper portion of the logo, with a registered trademark symbol to the right. Below "COOK" is the word "MEDICAL" in white, sans-serif font.

5.0 510(k) SUMMARY

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-0489 U 39.2235 TOLLEREE: 800.457 WWW.COOKMEDICAL.COM

K171997 Page 1 of 3

Mandril Wire Guide 21 CFR §807.92 Date Prepared: February 23, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Jennifer L. Allman
Applicant Address:	Cook Incorporated
	750 Daniels Way
	Bloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104280
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Mandril Wire Guide
Common Name:	Wire, Guide, Catheter
Classification Name:	Catheter guide wire
Regulation:	21 CFR §870.1330
Product Code:	DQX

Predicate Device:

The predicate device is the Spring Coil Guidewire (Neometrics, Inc., K143135) cleared for market on February 20, 2015.

Reference Device:

The reference device is the ASAHI Peripheral Guide Wires (Asahi Intecc Co., LTD., K150445) cleared for market on June 30, 2015.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font. Below "COOK" is the word "MEDICAL" in white, bold, sans-serif font, set against a red background.

Page 2 of 3

Device Description:

Intended Use:

The intended use of the Mandril Wire Guide is to facilitate the placement of devices during diagnostic and interventional procedures.

Comparison to Predicate:

The Mandril Wire Guide, subject of this submission, is substantially equivalent to the predicate device, the Spring Coil Guidewire (K143135), in that these devices have identical indications for use. Although the Mandril Wire Guide utilizes a shorter coil configuration and additional coil materials as compared to the Spring Coil Guidewire (K143135), the subject device and the predicate device have similar technological characteristics and the same therapeutic effect.

Technological Characteristics:

The following tests were performed to demonstrate that the Mandril Wire Guide, subject of this submission, met applicable design and performance requirements and support a determination of substantial equivalence.

Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
. Corrosion Testing - Tested in accordance with Annex B of ISO 11070:2014. The pre-determined acceptance criteria were met.
. Flexing Test – Tested in accordance with the Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
. Fracture Testing - Tested in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".

Page 3 of 3

. Tensile Testing - Tested in accordance with the applicable values of BS EN ISO 11070:2014, Annex H. The pre-determined acceptance criteria were met.
. Tip Flexibility Testing (Tip Deflection) – Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
. Torqueability Testing (Rotational Response) – Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.
. Torque Strength Testing - Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
. Radiopacity Testing - Tested in accordance with ASTM F640-12. The predetermined acceptance criteria were met.
Surface Examination - Tested in accordance with BS EN ISO 11070:2014 Section 4.3. The pre-determined acceptance criteria were met.
. Dimensional Measurement Testing – Tested in accordance with an approved study protocol. The pre-determined acceptance criteria were met.
. Catheter Compatibility Testing - Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Acute Performance Evaluation - Evaluation of device performance in an animal model under conditions intended to simulate clinical use. All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.

Conclusion:

The results of these tests support a conclusion that the Mandril Wire Guide, subject of this submission, met the design input requirements based on the intended use and support the conclusion this device does not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Spring Coil Guidewire (K143135).

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.