The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Device Description

The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the R350 Guidewire. The content focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria through a trial. As such, information regarding clinical study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is largely not applicable in the context of this 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the "results of the design verification and validation tests met the specified acceptance criteria" for a series of mechanical and biocompatibility tests. However, the specific quantitative acceptance criteria and the numerical reported device performance for each test are not provided in this summary. Only the types of tests conducted are listed.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Hydrophilic Coating Particulate	Passed
Hydrophilic Coating Delamination Inspection (after Fracture Test)	Passed
Fluoroscopy Visualization	Passed
Guidewire O.D.	Passed
Guidewire Length	Passed
Component Alignment	Passed
Interface with Other Devices	Passed
Torqueability	Passed
Torque	Passed
Flex	Passed
Fracture	Passed
Tip Deflection Force	Passed
Tip Load	Passed
Distal Solder Joint Tensile	Passed
Proximal Solder Joint Tensile	Passed
Corrosion	Passed
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, ASTM Hemolysis, Complement Activation, ASTM Platelet and Leukocyte Count Assay, Partial Thromboplastin Time, In Vivo Thrombogenicity)	Passed (per ISO 10993-1)

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

Sample Size for Test Set: Not specified for any of the listed tests. The document only mentions "device samples."
Data Provenance: Not specified. Given that these are design verification and validation tests, they are likely performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc. in Minneapolis, USA) during device development, which would make them prospective tests, but this is an inference.

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)

Not Applicable. The ground truth for these engineering and biocompatibility tests is established by standardized testing methods and quantifiable metrics, not by expert consensus in a clinical context.

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

Not Applicable. As these are performance tests against engineering specifications and international standards, there is no adjudication by human experts in the way clinical studies are adjudicated. Results are determined by test equipment and adherence to predefined protocols.

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 device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

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

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

The "ground truth" for the tests performed is based on:

Engineering Specifications: For mechanical tests like guidewire dimensions, torque, flex, fracture, etc.
International Standards: Specifically, ISO 10993-1 for biocompatibility tests.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI algorithm.

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2015

Vascular Solutions, Inc. Beka Vite Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55639

Re: K151234

Trade/Device Name: R350 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: October 16, 2015 Received: October 19, 2015

Dear Ms. Vite:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Hillebrenner
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) K151234

Device Name R350 Guidewire

Indications for Use (Describe)

The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature

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)

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510(k) Summary [As required by 21 CFR 807.92] Date Prepared: May 06, 2015 510(k) Number: K151234

Submitter's Name / Contact Person

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

Contact Person

Beka Vite Regulatory Product Specialist Tel: 763-657-5732 Fax: 763-656-4253

General Information

Trade Name	R350 guidewire
Common / Usual Name	Guidewire
Classification Name	21 CFR 870.1330, DQX – catheter guidewire
Predicate Devices	K021990 – R350 guidewire (Galt Medical Corp.)K141339 - Asahi RG3 guidewire (Asahi Intecc Co., Ltd.)

Device Description

Indications for Use

The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Technological Characteristics Comparison

The R350 guidewire is similar in design and intended use to the predicate devices as they are all guidewires intended for use in percutaneous procedures. The R350 guidewire and predicate devices are similar in size, and all have a radiopaque tip and lubricous coating.

Substantial Equivalence and Summary of Studies

The technological differences between the R350 guidewire and predicate devices were evaluated through biocompatibility and mechanical tests, and results did not raise new questions of safety or effectiveness.

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The R350 guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The R350 guidewire design has been verified through the following tests and inspections:

Hydrophilic Coating Particulate ●
Hydrophilic Coating Delamination Inspection (after Fracture Test) .
Fluoroscopy Visualization ●
Guidewire O.D. ●
Guidewire Length
Component Alignment .
Interface with Other Devices .
Torqueability
Torque ●
Flex .
. Fracture
Tip Deflection Force ●
Tip Load
Distal Solder Joint Tensile ●
. Proximal Solder Joint Tensile
Corrosion

Device samples passed the following biocompatibility tests per ISO 10993-1:

. Cytotoxicity
. Sensitization
Irritation ●
Acute Systemic Toxicity ●
Material Mediated Pyrogenicity .
ASTM Hemolysis
Complement Activation .
ASTM Platelet and Leukocyte Count Assay ●
Partial Thromboplastin Time .
In Vivo Thrombogenicity

The results of the design verification and validation tests met the specified acceptance criteria and did not raise new questions of safety and effectiveness. Therefore, the R350 guidewire is substantially equivalent to the predicate devices.

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.