The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides have flexible distal and proximal ends. Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Double Flexible Tipped Wire Guides (K171912), to include an additional diameter of 0.015 inches to the uncoated configurations with lengths of 30, 40, and 60 centimeters. Additionally, the subject device has been modified from the predicate device to include coated configurations for the existing 0.021 and 0.025 inch diameter devices with lengths of 40, 50, and 60 centimeters.

The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior PTFE coating on the coils.

The modification to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single patient use and labeled with a five-year shelf life.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Double Flexible Tipped Wire Guides." The submission aims to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the level of detail required to answer all parts of your request, specifically regarding acceptance criteria and study design for AI/machine learning models in a medical context. The document describes a traditional medical device (wire guides) and the testing conducted relates to the physical and mechanical properties of this device, not to an AI algorithm's performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it does not involve an AI/ML device.

Below, I will extract the information that is present and explicitly state when information is not available or not applicable based on the content.

Description of Acceptance Criteria and Study Proving Device Meets Criteria

The device in question is a physical medical device (Double Flexible Tipped Wire Guides), not an AI/ML algorithm. The performance testing revolves around the mechanical and material integrity of the wire guide, not an algorithm's ability to interpret data or images.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each test, "The pre-determined acceptance criteria were met." However, it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only reports that the device passed.

Test Name	Acceptance Criteria (Not Detailed in Document)	Reported Device Performance
Corrosion Testing (BS EN ISO 11070:2014 Annex B)	(Pre-determined acceptance criteria)	Revealed no signs of corrosion that would affect functional performance. Met.
Flexing Test (BS EN ISO 11070:2014 Annex G)	(Pre-determined acceptance criteria)	Met.
Torque Strength Testing (FDA Coronary and Cerebrovascular Guidewire Guidance 1995)	(Characterization testing)	Performance characterized. (Implied to be acceptable for substantial equivalence).
Fracture Testing (BS EN ISO 11070:2014 Annex F)	(Pre-determined acceptance criteria)	Met.
Tensile Testing (BS EN ISO 11070:2014 Annex H)	(Pre-determined acceptance criteria)	Met.
Tip Flexibility (Tip Deflection) Testing (FDA Coronary and Cerebrovascular Guidewire Guidance 1995)	(Characterization testing)	Performance characterized. (Implied to be acceptable for substantial equivalence).
Catheter Compatibility Testing (BS EN ISO 11070:2014)	(Pre-determined acceptance criteria)	Met.
Performance Testing on Aged Devices (BS EN ISO 11070:2014)	(Pre-determined acceptance criteria)	Met.

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

Sample Size: Not specified in the provided text for any of the tests.
Data Provenance: Not applicable in the context of data for an AI/ML model. The tests are laboratory/benchtop tests of physical device properties, not data collected from patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. This device is hardware, not an AI/ML system that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device, there's no need for adjudication of readings or interpretations. The tests likely followed defined protocols with objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for assessing the impact of AI on human readers for diagnostic or interpretive tasks. Since this is a physical medical device, an MRMC study was not conducted and is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Specifications: The "ground truth" for this device's performance is compliance with established international standards (e.g., BS EN ISO 11070:2014) and FDA guidance documents (e.g., FDA Coronary and Cerebrovascular Guidewire Guidance 1995). The tests aim to demonstrate that the device's physical properties meet these pre-defined engineering requirements. This is sometimes referred to as "benchtop testing" or "performance testing."

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. This is a physical device; there is no training set or associated ground truth for an algorithm.

Summary

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June 14, 2018

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

Re: K181351

Trade/Device Name: Double Flexible Tipped Wire Guides Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 21, 2018 Received: May 22, 2018

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K181351

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 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,

Michael John -S 2018.06.14 14:46:55 -04'00'

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) K181351

Device Name Double Flexible Tipped Wire Guides

Indications for Use (Describe)

The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

Type of Use (Select one or both, as applicable)
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X 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: May 30, 2018
Submission:	Special 510(k) Premarket Notification
Device:
Trade Name:	Double Flexible Tipped Wire Guides
Common Name:	Catheter Wire Guide
Classification Name:	Wire, Guide, Catheter

Indications for Use:

The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

DQX (21 CFR §870.1330)

Predicate Device:

The predicate device, manufactured by Cook Incorporated, is the Double Flexible Tipped Wire Guides, cleared for commercial distribution under 510(k) number K171912, on March 19, 2018.

Reference Device:

The reference device, manufactured by Cook Incorporated, is the Fixed Core Wire Guides cleared for commercial distribution under 510(k) number K171764 cleared for market on March 9, 2018.

Comparison to Predicate Device:

It has been demonstrated that the Double Flexible Tipped Wire Guides are identical to the predicate device (K171912) in terms of intended use, principles of operation, basic technological characteristics, and materials of construction. The subject device packaging, sterilization method, and shelf life have not changed from the predicate device. An additional wire guide diameter has been included for the uncoated subject device configuration as compared to the predicate device and coating has been added to existing predicate device configurations. The substantial equivalence of the subject device modification is supported by performance testing.

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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 large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".

Device Description:

The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior PTFE coating on the coils.

The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single patient use and labeled with a five-year shelf life.

There are no prior submissions for the subject device.

Test Data:

The following tests were performed to demonstrate that the Double Flexible Tipped Wire Guides met applicable design and performance requirements and support a determination of substantial equivalence:

. 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.
Flexing Test Testing was performed in accordance with Annex G of BS EN ISO . 11070:2014. The pre-determined acceptance criteria were met.
Torque Strength Testing Characterization testing was performed in accordance with the . FDA Coronary and Cerebrovascular Guidewire Guidance (1995).

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Image /page/5/Picture/0 description: The image is a logo for Cook Medical. The logo is set on a red background. The word "COOK" is in white, sans-serif font in the upper portion of the logo, and the word "MEDICAL" is in white, sans-serif font in the lower portion of the logo.

I 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.
. Tip Flexibility (Tip Deflection) Testing – Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Catheter Compatibility Testing – Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
. Performance Testing on Aged Devices – Performance testing was repeated on aged devices in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.

Conclusion:

In conclusion, the results of these tests support a determination that the Double Flexible Tipped Wire Guides met the design input requirements based on the intended use and support the conclusion that the modifications to the device do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Double Flexible Tipped Wire Guides (K171912).

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.