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

Device Description

The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.

AI/ML Overview

The provided text is a 510(k) summary for the Raider Guidewire. It outlines the device's indications, technological characteristics, and testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the kind of detailed information about acceptance criteria or a study design (like sample size for test sets, data provenance, expert demographics, adjudication methods, MRMC studies, or standalone algorithm performance) that you would typically find for an AI/ML medical device.

The Raider Guidewire is a physical medical device (a catheter guide wire), not an AI/ML software device. Therefore, the questions posed in the prompt, which are highly specific to the evaluation of AI/ML diagnostic or predictive algorithms, are not applicable to the information provided in this 510(k) summary.

The document discusses "acceptance criteria" in a general sense through performance testing for mechanical properties and biocompatibility.

Here's the information that can be extracted or inferred from the provided text, while acknowledging that many of your questions cannot be answered because they pertain to a different type of device:

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

The document doesn't provide specific numerical acceptance criteria for each test (e.g., "Tensile strength > X Newtons"). Instead, it states that "Device samples passed the following biocompatibility tests" and "The device design has been verified through the following tests." This implies that predefined acceptance criteria were met, but the specific values are not detailed.

Acceptance Criteria (Implied)	Reported Device Performance
Tensile Strength acceptable	Verified, Passed
Torque Strength acceptable	Verified, Passed
Torqueability acceptable	Verified, Passed
Tip Flexibility acceptable	Verified, Passed
Coating Adherence/Integrity acceptable	Verified, Passed
Catheter Compatibility acceptable	Verified, Passed
Dimensional Analysis acceptable	Verified, Passed
Radiopacity acceptable	Verified, Passed
Corrosion acceptable	Verified, Passed
Cytotoxicity acceptable	Passed
Sensitization acceptable	Passed
Irritation acceptable	Passed
Acute Systemic Toxicity acceptable	Passed
Material Mediated Pyrogenicity acceptable	Passed
Hemolysis acceptable	Passed
Complement Activation acceptable	Passed
Thrombogenicity acceptable	Passed

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. For mechanical and biocompatibility testing of a physical device, samples are typically manufactured batches tested in a lab setting, not "test sets" in the AI/ML sense. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of testing.

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/provided. "Ground truth" in the context of this device refers to objective measurements derived from physical and chemical tests, not expert interpretation of data.

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

This information is not applicable/provided. Adjudication methods are relevant for human interpretation tasks, not for the objective testing of physical device properties.

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/provided. MRMC studies and AI assistance are relevant for AI/ML diagnostic devices, not for a guidewire.

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

This information is not applicable/provided. This refers to AI algorithm performance, which is not relevant for this physical device.

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

The "ground truth" for this device's performance is based on objective measurements from standard mechanical, material, and biological tests (e.g., tensile strength testing, chemical assays for biocompatibility, dimensional measurements). It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic system would be evaluated.

8. The sample size for the training set:

This information is not applicable/provided. Training sets are for AI/ML models. This device is a physical product.

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

This information is not applicable/provided. (See #8).

Summary

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December 15, 2017

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

Re: K173532

Trade/Device Name: Raider Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: November 13, 2017 Received: November 15, 2017

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 Mav 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);

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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 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

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Indications for Use

510(k) Number (if known)

K173532

Device Name Raider guidewire

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart

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

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510(K) SUMMARY

[As required by 21 CFR 807.92]

Date Prepared: October 20, 2017

510(k) Number: __K173532

Submitter's Name / Contact Person

Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person

Beka Vite Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Raider guidewire
Common / Usual Name	Guidewire
Classification Name	21 CFR 870.1330
Predicate Device	Spectre Guidewire (K163444 - Vascular Solutions, Inc.; January 6, 2017)
Reference Device	Hi-Torque Pilot 200 (K101116 – Abbott Vascular; June 23, 2010)R350 Guidewire (K151234 - Vascular Solutions, Inc.; November 18, 2015)

Device Description

Intended Use

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

Technological Characteristics Comparison

The table below compares the technological characteristics of the Raider guidewire and the predicate device.

Characteristic	Raider Guidewire	Predicate Device
Maximum Diameter	0.014"	Same
Lengths	190 cm, 300 cm	Same
Core Wire Material	Stainless Steel with DistalPolymer Jacket	Nitinol and Stainless Steel
Distal Tip	Radiopaque Coil	Same

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Characteristic	Raider Guidewire	Predicate Device
Lubricious Coatings	Hydrophilic (Distal)PTFE (Proximal)	Same

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence for the Raider guidewire. The device design has been verified through the following tests:

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

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

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

The Raider guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The minor technological and material differences between the Raider guidewire and the predicate device raise no new questions of safety or effectiveness. Performance data demonstrate that the Raider guidewire is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Raider 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.