The Fixed Core Wire Guides, subject of this submission, are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a core mandril, a spring coil anchored over the mandril, and an inner safety wire. The Fixed Core Wire Guides are available with outside diameters ranging from 0.015 inches to 0.052 inches and lengths ranging from 15 centimeters to 480 centimeters. The flexible tip portion of the wire guides is either straight or J-tipped. The Fixed Core Wire Guides will be uncoated or coated with Polytetrafluoro-ethylene (PTFE). The Fixed Core Wire Guides are packaged, sterile devices intended for single use.

AI/ML Overview

The document describes the premarket notification (510(k)) for the Fixed Core Wire Guides. However, it does not pertain to an AI/ML medical device. Therefore, much of the information requested in your prompt (e.g., patient data, training/test sets, expert consensus, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it is for a physical medical device (wire guides).

The "study that proves the device meets the acceptance criteria" refers to the various engineering and biological tests conducted on the physical device.

Here's an attempt to answer the prompt based on the provided document, acknowledging the non-AI nature of the device:

Device: Fixed Core Wire Guides (K171764)
Device Type: Physical Medical Device (Catheter Guide Wire)
Regulation: 21 CFR 870.1330 (Catheter Guide Wire)

Given that this is a 510(k) submission for a physical medical device (wire guide) and not an AI/ML-driven device, many of the standard questions regarding AI/ML acceptance criteria and study design are not relevant or applicable. The "acceptance criteria" here refer to the passing thresholds for various physical and biological performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria values or detailed performance results for each test. Instead, it states that "The pre-determined acceptance criteria were met" for all listed tests.

Test Category	Acceptance Criteria Description (as stated)	Reported Device Performance (as stated)
Biocompatibility	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 Annex G of ISO 11070:2014.	The pre-determined acceptance criteria were met.
Fracture Testing	Tested in accordance with Annex F of ISO 11070:2014.	The pre-determined acceptance criteria were met.
Tensile Testing	Tested in accordance with ISO 11070:2014, Annex H.	The pre-determined acceptance criteria were met.
Tip Flexibility	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	(No explicit statement of "met criteria," but characterization was successful)
Torque Strength Testing	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	(No explicit statement of "met criteria," but characterization was successful)
Acute Performance Evaluation	Evaluated in an animal model in accordance with an approved study protocol.	The pre-determined acceptance criteria were met.

2. Sample size used for the test set and the data provenance

For a physical device, "sample size" typically refers to the number of device units tested. The document does not specify the exact sample sizes (number of units) used for each of the performance tests (e.g., biocompatibility samples, number of wires for tensile testing, etc.).

Data Provenance: The tests are laboratory and animal studies, not human clinical data.
- Biocompatibility, Corrosion, Flexing, Fracture, Tensile, Tip Flexibility, Torque Strength: Performed in a laboratory setting.
- Acute Performance Evaluation: Performed in an animal model.
Retrospective or Prospective: These would be considered prospective tests performed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For physical device performance testing, "ground truth" is established by the test procedures themselves (e.g., measuring force, observing breakage, biological reactions) and assessed by qualified laboratory personnel and engineers, not clinical experts for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is relevant for human interpretation of data, not for material or mechanical performance testing of a physical device.

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 for AI/ML devices where human readers interact with AI. This device is a physical wire guide.

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

Not applicable. This pertains to AI/ML software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" for demonstrating performance is derived from:

Standardized industry and international test methods (e.g., ISO, FDA guidance documents).
Quantitative measurements (e.g., force, elongation, cycles to failure).
Qualitative observations (e.g., absence of corrosion, successful access in animal model).
Biocompatibility assessments based on established biological endpoints.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from patient data. The "training" for such a device would be the design and manufacturing processes.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 9, 2018

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

Re: K171764

Trade/Device Name: Fixed Core Wire Guides Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: February 7, 2018 Received: February 7, 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 (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171764

Device Name Fixed Core Wire Guides

Indications for Use (Describe)

Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The bottom left corner of the red background is cut off at an angle.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-048 WW.COOKMED

510(k) SUMMARY

Fixed Core Wire Guides K171764 21 CFR §807.92 Date Prepared: March 8, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Jennifer L. Allman
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104280
Contact Fax Number:	(812) 332-0281

Device Information:

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

Predicate Device:

The InQwire® Merit Medical Guide Wire (Merit Medical Inc., K133230) is a fixed core wire guide intended to facilitate placement of devices during diagnostic and interventional procedures.

Reference Devices:

The following devices were referenced in the substantial equivalence discussion for the subject device:

{4}------------------------------------------------

Mandrel Guidewires or M-Wires (Lake Region Medical, K140485) cleared for market on September 24, 2014.

Sunmed Guide Wires (Sunny Medical Device (Shenzhen Co., Ltd., K120119) cleared for market on May 11, 2012.

ASAHI SION Blue PTCA Guide Wire (Asahi Intecc Co., Ltd., K122468) cleared for market on March 8, 2013.

Predicate III Guidewire (Lake Region Medical, K142393) cleared for market on November 25, 2014.

Device Description:

Intended Use:

The Fixed Core Wire Guides are intended to facilitate placement of devices during diagnostic and interventional procedures.

Comparison to Predicates:

The proposed Fixed Core Wire Guides and the predicate device, the InQwire Merit Medical Guide Wire (K133230), are substantially equivalent in that these devices have identical indications for use. The proposed Fixed Core Wire Guides are similar in design, technological characteristics, and materials to the InQwire Merit Medical Guide Wire (K133230).

Technological Characteristics:

The following tests were performed to demonstrate that the Fixed Core Wire Guides met applicable design and performance requirements and their results support a determination of substantial equivalence.

Biocompatibility Testing Tested in accordance with ISO 10993-1:2009. The . pre-determined acceptance criteria were met.

{5}------------------------------------------------

. 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 ISO 11070:2014. The pre-determined acceptance criteria were met.
I Fracture Testing - Tested in accordance with Annex F of ISO 11070:2014. The pre-determined acceptance criteria were met.
. Tensile Testing - Tested in accordance with ISO 11070:2014, Annex H. The predetermined acceptance criteria were met.
. Tip Flexibility – Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Torque Strength Testing - Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
. Acute Performance Evaluation - The acute performance of the subject device was evaluated in an animal model in accordance with an approved study protocol. The pre-determined acceptance criteria were met.

Conclusion:

The results of these tests support a conclusion that the Fixed Core Wire Guides met the design input requirements based on the intended use and support the conclusion that these devices do not raise new issues of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the InQwire Merit Medical Guide Wire (K133230).

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.