The ENROUTE .014” guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The very distal tip section is flattened to further reduce stiffness and enable the tip to be shaped.

The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in straight configuration

AI/ML Overview

This document describes the 510(k) premarket notification for the ENROUTE 0.014" Guidewire, which is intended for use in the peripheral vasculature. The device demonstrates substantial equivalence to predicate devices (Brivant Guidewire K060551 and Nitrex Nitinol Guidewire K040345) based on technological characteristics, performance testing, and intended use.

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 does not explicitly state numerical "acceptance criteria" in a table format for each test. Instead, it states that "The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices." This implies that the device's performance results were within acceptable ranges to demonstrate substantial equivalence to the predicate devices. The types of tests performed are listed, and for some, the new device had specific data generated ("X") or leveraged data from a predicate ("X").

Test	Acceptance Criteria (Implied: Met Predicate Performance/Specifications)	Reported Device Performance (Implied: Met Criteria)
Tensile Strength	Equivalent to predicate device	Met
Torque Strength	Equivalent to predicate device	Met
Dimensional measurements (Overall length)	Within range of predicate device	Met
Torque Response	Equivalent to predicate device	Met
Catheter Compatibility	Compatible with equivalent interventional devices	Met
Coating Adherence/Coating Integrity	Equivalent to predicate device	Met
Particulate Testing	Equivalent to predicate device	Met
Tip Stiffness/Flexibility	Equivalent to predicate device	Met
Radiopacity	Visible on x-ray equipment (radiopaque)	Met
Biocompatibility	In compliance with ISO 10993-1:2009 and G95-1	Met
Shelf Life	Established	Met

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

The document mentions "in vitro bench tests" but does not specify the sample sizes used for each test. The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from "Lake Region Medical" in "Galway, Ireland."

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 is a medical device submission, not an AI/software claim. Therefore, the concept of "ground truth established by experts" as typically understood in AI studies (e.g., radiologists labeling images) does not apply here. The "acceptance criteria" and "performance" are based on engineering specifications and bench testing, not expert consensus on diagnostic interpretations.

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

Not applicable as this is a medical device bench testing study, not an expert-driven AI study.

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 as this is a medical device bench testing study, not an AI comparative effectiveness study.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, FDA guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"), and established performance characteristics of the predicate devices. For biocompatibility, the ground truth is adherence to internationally recognized standards like ISO 10993-1:2009.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, layered on top of each other.

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

October 18, 2016

Lake Region Medical Mr. Michael Dunning QA/RA Manager Parkmore West Business Park Galway G07001 Ireland

Re: K160643

Trade/Device Name: ENROUTE 0.014" Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 7, 2016 Received: September 9, 2016

Dear Mr. Dunning:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (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.

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,

Brian D. Pullin -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) K160643

Device Name ENROUTE 0.014" Guidewire

Indications for Use (Describe) The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.

Contraindications:

ENROUTE 0.014" Guidewire is not intended for use in:

The cerebral or coronary vasculature
Patients judged not acceptable for percutaneous intervention

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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510(k) Summary – ENROUTE 0.014” Guidewire
K160643 - Traditional 510(k)

Device Name	ENROUTE 0.014" Guidewire
Submitters name	Brivant Ltd T/A Lake Region Medical International Research &Development Centre,Parkmore West Business Park,Co. Galway,Ireland.
ApplicationCorrespondent	Michael DunningQA/RA ManagerBrivant Ltd T/A Lake Region Medical International Research &Development CentreTel: +353 91 385391Fax: +353 91 766598
SummaryPreparation Date	7th September 2016
Device Name &Classification	Trade Name:	ENROUTE 0.014" Guidewire
	Common Name:	Guidewire
	Classification Name:	Catheter, Guidewire
	Device Classification:	Class II, 21 CFR §870.1330
	Product Code:	DQX
Intended Use	Intended Use:	The ENROUTE 0.014" Guidewire is intended for use in the peripheralvasculature.
		Contraindications:ENROUTE 0.014" Guidewire is not intended for use in:● The cerebral or coronary vasculature.● Patients judged not acceptable for percutaneous intervention.
Device Description	The ENROUTE .014” guidewire is a disposable medical device designed forsingle use only. It consists of a 95cm PTFE coated 0.014" diameterstainless steel core wire, one end of which is reduced in diameter overapproximately 9.5cm in a progressive fashion through a centrelessgrinding operation. The profile of this reduced section affords the productan area of reduced stiffness. The very distal tip section is flattened tofurther reduce stiffness and enable the tip to be shaped.The distal section is covered with a 5cm platinum tungsten spring coil. Thisprovides for greater visibility on x-ray equipment (radiopacity). Ahydrophilic coating is applied to the distal section to enhance lubricity. Theproduct is available in straight configuration

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Predicate Device	Manufacturer	510k	Date
	Brivant Guidewire (Rapidwire Plus variant –previously known as SLK)	K060551	06/07/2006
	Nitrex Nitinol Guidewire	K040345	03/02/2004
Principle of Operation	The ENROUTE 0.014" guidewire is operated manually by a manual process
Comparison of Technological Characteristics	The key technological and performance similarities examined between theapproved devices and the proposed ENROUTE 0.014" Guidewire deviceare as follows:- Indications for use - The Indications for use for the proposeddevice is a subset of indications for use of the predicate device asproposed device, ENROUTE 0.014" is for peripheral vasculatureonly- Contraindications – The contraindications for use are very similarto that of the predicate device Nitrex Nitinol Guidewire. TheENROUTE 0.014" device has an additional contraindication to thepredicate Rapidwire Plus against use in the Coronary Vasculature.- Fundamental scientific technology, including design - identical tothe predicate devices- Operating principle - identical to the predicate devices- Packaging materials - identical to the predicate device RapidwirePlus- Sterility assurance level and method of sterilization - identical tothe predicate devices- The length of the device is within the length range of the predicatedevice; Nitrex Nitinol Guidewire- The diameter of the proposed device is within the diameter rangeof the predicate devices (0.014")- The proposed device and that of the Rapidwire Plus device areidentical in that they are constructed with a stainless steel corewhich is reduced in diameter at the distal end to provide flexibility- The proposed device has equivalent tip stiffness characteristics tothat the Rapidwire Plus device- The proposed device has an identical hydrophilic coating to that ofthe Rapidwire Plus device at the distal tip- All devices have a PTFE coating on the guidewire shaft- The proposed device and that of the Rapidwire Plus device haveequivalent torque response properties

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Image /page/5/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized heart shape in red and gray, followed by the words "Lake Region" in a sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller, light gray font. The heart shape is made up of several geometric shapes, creating a modern and professional look.

Compatible with equivalent interventional devices

PerformanceTesting (non-clinical)	In vitro bench tests were utilized to demonstrate equivalence withreference to the FDAs guidance document "Coronary and CerebrovascularGuidewire Guidance, Jan 1995".
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The following bench tests support the proposed product:

Test	Leveraged fromPredicate510(k) Data	ENROUTE 0.014"510(k) data
Tensile Strength	X
Torque Strength		X
Dimensional measurements	X	X(Overall length)
Torque Response		X
Catheter Compatibility		X
Coating Adherence/CoatingIntegrity	X
Particulate Testing	X
Tip Stiffness/Flexibility	X
Radiopacity		X
Biocompatibility	X
Shelf Life	X

The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices.

Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

Conclusions Based on safety and performance testing, technological characteristics and the indications for use for the device, the ENROUTE 0.014" Guidewire has been demonstrated to be appropriate for its intended use and is considered to be 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.