The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

Device Description

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.

AI/ML Overview

The provided document is a 510(k) summary for the Warrior 14 guidewire, a medical device. It does not describe an AI/ML device or a study comparing AI performance against acceptance criteria. Instead, it details the substantial equivalence determination process for a traditional medical device (a guidewire) based on biocompatibility and bench testing.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI is not applicable to this document. The document focuses on the physical and material properties of the guidewire and its comparison to a predicate device.

However, I can extract the acceptance criteria and performance data for the guidewire as presented in the document, which are primarily related to safety and performance through bench and biocompatibility testing.

Here's a summary of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance

Test Category	Acceptance Criteria (Implied by testing)	Reported Device Performance
Biocompatibility	Device must be non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant. (Based on ISO 10993-1)	Passing results from biomaterial tests demonstrate that the Warrior 14 guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant.
Performance - Bench	Device must meet specified criteria for catheter compatibility, coating adherence/integrity, corrosion resistance, dimensional analysis, radiopacity, tensile strength, tip flexibility, tip shapeability, torqueability, and torque strength, and not raise different questions of safety or effectiveness.	The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.
Substantial Equivalence	The device should not raise different questions of safety and effectiveness compared to the predicate device, and be substantially equivalent in technology, materials, and performance.	The technological differences do not raise different questions of safety and effectiveness. The Warrior 14 guidewire is identical to the predicate device in its indications for use and substantially equivalent in technology, materials, and performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "biomaterial tests" and "verification tests" but does not specify the sample sizes (e.g., number of guidewires tested for each bench test) or data provenance. These are typically internal lab tests conducted by the manufacturer.

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)

This information is not applicable as the document describes a physical medical device (guidewire) and its bench/biocompatibility testing, not an AI device requiring expert ground truth for image or data interpretation.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI algorithm.

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

For the biocompatibility tests, the "ground truth" is established by the specified standards (ISO 10993-1) and the observed biological responses. For the bench performance tests, the "ground truth" is the established engineering specifications and measurement results. These do not involve expert consensus in the typical sense of diagnostic interpretation.

8. The sample size for the training set

This information is not applicable as the document describes the testing of a physical medical device (guidewire), not an AI/ML model that requires a training set.

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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February 16, 2018

Vascular Solutions. Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K180128

Trade/Device Name: Warrior 14 guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2018 Received: January 17, 2018

Dear Mark Job:

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. Iisting 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);

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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 medical devices and radiation-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)

K180128

Device Name Warrior 14 guidewire

Indications for Use (Describe)

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

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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Image /page/3/Picture/0 description: The image shows the logo for Vascular Solutions. The logo features a tan square with a series of black squares above it that decrease in size as they move upwards, creating a visual effect similar to smoke or a rising pattern. Below the square is the word "Vascular" in a bold, serif typeface, with the word "SOLUTIONS" underneath in a smaller, sans-serif font.

510(k) Summary

[As required by 21 CFR 807.92]

K180128 510(k) NUMBER:

SUBMITTER

Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Phone: 763-656-4300 Fax: 763-656-4253 Contact Person: Becky Astrup, Regulatory Product Specialist Date Prepared: December 8, 2017

DEVICE

Name of Device: Warrior 14 guidewire Common or Usual Name: Catheter Guidewire Classification Name: Catheter Guidewire (21 CFR 870.1330) Regulatory Class: II Product Code: DQX

PREDICATE/REFERENCE DEVICES

The legally marketed devices to which substantial equivalence is claimed is:

Vascular Solutions Spectre guidewire, K163444 (cleared January 6, 2017)

The Asahi Confianza Pro 12 guidewire, K041531 (cleared August 3, 2004) and the Vascular Solutions R350 guidewire, K151234 (cleared November 18, 2015) are included as reference devices for this submission.

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DEVICE DESCRIPTION

INDICATIONS FOR USE

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the technological characteristics of the Warrior 14 guidewire and, Spectre guidewire predicate.

Characteristic	Subject Device:Warrior 14	Predicate Device:Spectre
Maximum Diameter	0.014''	Identical
Lengths	190cm, 300cm	Identical
Tip Configuration	Straight, Shapeable	Identical
Lubricious Coating- Distal	Hydrophilic	Identical
Lubricious Coating- Proximal	PTFE	Identical
Core Wire Material	Stainless Steel	SimilarNitinol and Stainless Steel
Radiopaque Material	Platinum, Tungsten	Identical
Radiopaque Tip Length	2.5cm	Equivalent3cm
Tip O.D.	0.009"	Similar0.014"
Tip Load	14g	Similar< 1.5g

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Warrior 14 guidewire was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Warrior 14 guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (<24 hours) during use. The battery of tests included the following:

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Cytotoxicity
Sensitization .
Irritation
Acute Systemic Toxicity ●
Material Mediated Pyrogenicity
Hemolysis
Complement Activation ●
Thombogenicity ●

Passing results from biomaterial tests demonstrate that the Warrior 14 guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant.

Performance Testing- Bench

The device design was verified through the following tests:

Catheter Compatibility ●
Coating Adherence/Integrity .
Corrosion Resistance .
Dimensional Analysis ●
Radiopacity ●
Tensile Strength ●
Tip Flexibility ●
Tip Shapeability .
Torqueability ●
Torque Strength .

The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.

CONCLUSIONS

In summary, the technological differences between the Warrior 14 guidewire, subject of this 510(k) and the predicate device do not raise different questions of safety and effectiveness. The Warrior 14 guidewire is identical to the predicate device in its indications for use and substantially equivalent in technology, materials, and performance to the predicate device. Performance data demonstrate that the Warrior 14 guidewire is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Warrior 14 guidewire 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.