The Bandit 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 Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 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 Bandit guidewire, which is a medical device. This document describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

Crucially, this document describes a medical device (a guidewire), not a software or AI-powered medical device. Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of device and study. The "acceptance criteria" here refer to standard engineering and biocompatibility tests for a physical device, not performance metrics of a diagnostic or AI algorithm.

Here's a breakdown of the information that is available, and why other parts are not:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Bench Performance Testing	Met specified acceptance criteria	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Tensile Strength	Specific engineering standards (not fully detailed in this document)	Passed
Torque Strength	Specific engineering standards (not fully detailed in this document)	Passed
Torqueability	Specific engineering standards (not fully detailed in this document)	Passed
Tip Flexibility	Specific engineering standards (not fully detailed in this document)	Passed
Coating Adherence/Integrity	Specific engineering standards (not fully detailed in this document)	Passed
Catheter Compatibility	Specific engineering standards (not fully detailed in this document)	Passed
Dimensional Analysis	Specific engineering standards (not fully detailed in this document)	Passed
Radiopacity	Specific engineering standards (not fully detailed in this document)	Passed
Corrosion	Specific engineering standards (not fully detailed in this document)	Passed
Biocompatibility Testing (ISO 10993-1)	Various biological safety standards (e.g., non-cytotoxic, non-sensitizing)	Passing results
Cytotoxicity	(Acceptance criteria for non-toxicity)	Non-cytotoxic
Sensitization	(Acceptance criteria for non-sensitization)	Non-sensitizing
Irritation	(Acceptance criteria for non-irritation)	Non-irritating
Acute Systemic Toxicity	(Acceptance criteria for non-toxicity)	Non-systemically toxic
Material Mediated Pyrogenicity	(Acceptance criteria for non-pyrogenicity)	Non-pyrogenic
Hemolysis	(Acceptance criteria for non-hemolytic)	Non-hemolytic
Complement Activation	(Acceptance criteria for non-activation)	Not an activator of the complement system
Thrombogenicity	(Acceptance criteria for non-thrombogenicity)	Thromboresistant

The study that proves the device meets the acceptance criteria:

The study refers to a series of bench performance tests and biocompatibility tests. This is a pre-clinical study (laboratory-based testing), not a clinical trial involving human subjects for performance evaluation in the context of AI.

The document states: "The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests: [list of bench tests]. The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness."

For biocompatibility, it states: "The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1... The battery of tests included the following: [list of biocompatibility tests]. Passing results from biomaterial tests demonstrate that the Bandit guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant."

Information Not Applicable or Not Provided for this Device Type:

2. Sample sized used for the test set and the data provenance: Not applicable. These were laboratory bench and biocompatibility tests on physical device samples, not studies on "test sets" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical guidewire is established through engineering and biological testing standards and measurements, not expert consensus on medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device, in the spirit of your question, is established by engineering specifications and international standards (e.g., ISO 10993-1) for physical performance and biological safety.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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July 20, 2018

Vascular Solutions, Inc. Ms. Becky Astrup Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K181647

Trade/Device Name: Bandit Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: June 21, 2018 Received: June 22, 2018

Dear Ms. Astrup:

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

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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); 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 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,

Lydia S. Glaw -S 2018.07.20 15:51:10 -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)

K181647

Device Name Bandit guidewire

Indications for Use (Describe)

The Bandit 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)
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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 is a logo for Vascular Solutions. The logo features the word "Vascular" in a bold, serif font, with the word "Solutions" in a smaller, sans-serif font underneath. Above the text is a square shape with a gradient of black squares that fade out as they rise above the square. The square is a light tan color.

510(k) Summary

[As required by 21 CFR 807.92]

510(k) Number: _K181647

SUBMITTER AND DEVICE

Submitter:	Vascular Solutions, Inc.6464 Sycamore Court NorthMinneapolis, MN 55369 USA
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Date Prepared:	June 21st, 2018
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Name of Device:	Bandit guidewire
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Establishment Registration:	2134812
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Common or Usual Name:	Guidewire
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Phone:	763-656-4300
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Classification Name:	Catheter Guidewire(21 CFR 870.1330)
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Fax:	763-656-4253
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Regulatory Class:	II
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Contact Person:	Becky Astrup,Regulatory Product Specialist
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Product Code:	DQX
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PREDICATE DEVICE

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

Vascular Solutions Inc., Raider guidewire, K173532 cleared December 15, 2017.

The Asahi Intecc Co., LTD Fielder XT guidewire, K072431 cleared September 26, 2007 is included as a reference device for this submission.

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The Bandit 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 Bandit guidewire and the Raider guidewire predicate device.

Characteristic	Subject Device:Bandit	Predicate Device:Raider
Maximum Diameter	0.014"	Identical
Lengths	200 cm, 300 cm	Similar190cm, 300cm
Core Wire Material	Stainless Steel with DistalPolymer Jacket	Identical
Distal Tip	Radiopaque Coil	Identical
Lubricious Coatings	Distal: HydrophilicProximal: PTFE	Identical

PERFORMANCE DATA

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

Performance Testing - Bench

The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests:

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

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

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Biocompatibility Testing

The biocompatibility evaluation for the Bandit 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 Bandit 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:

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

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

CONCLUSION

The subject Bandit guidewire is substantially equivalent to the Raider guidewire predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The results of design verification tests do not raise new or different questions of safety and effectiveness; therefore, the Bandit 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.

Dear Ms. Astrup:

Lydia S. Glaw -S 2018.07.20 15:51:10 -04'00'

Indications for Use

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510(k) Summary

SUBMITTER AND DEVICE

PREDICATE DEVICE

Vascular Solutions Inc., Raider guidewire, K173532 cleared December 15, 2017.

DEVICE DESCRIPTION

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PERFORMANCE DATA

Performance Testing - Bench

Biocompatibility Testing

CONCLUSION

§ 870.1330 Catheter guide wire.

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