Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

Device Description

The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called "Hi Torque Connect Guidewire." This document focuses on demonstrating the substantial equivalence of a modified device to a previously cleared predicate device, rather than presenting a study of an AI algorithm's performance or a diagnostic device.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific ground truth types) are not applicable to this type of regulatory submission, as it deals with a physical medical device and its mechanical/material properties.

However, I can extract the acceptance criteria and performance data related to the device's physical properties.

Here's an analysis based on the information provided:

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

The document states that a design change involved a new PTFE coating for the guidewire. The performance testing was conducted to demonstrate the equivalence of the modified design to the existing design and to ensure the new coating does not adversely affect performance.

Performance Test	Acceptance Criteria (Implicit)	Reported Device Performance
Tensile Strength	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Torque Strength	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Dimensional Verification	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Torque Response	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Catheter Compatibility	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Coating Adherence/Integrity	Improved coating adhesion properties; no adverse effects	Demonstrated improved coating adhesion properties of the new PTFE coating and that the new process for application of the PTFE coating does not adversely affect other performance characteristics of the wire. Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Particulate Testing	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Tip Flexibility	Met defined product specifications (compared to predicate)	Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
PTFE Coating Adhesion	Improved coating adhesion properties; no adverse effects	Demonstrated improved coating adhesion properties of the new PTFE coating and that the new process for application of the PTFE coating does not adversely affect other performance characteristics of the wire. Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
PTFE Coating Durability	Improved coating adhesion properties; no adverse effects	Demonstrated improved coating adhesion properties of the new PTFE coating and that the new process for application of the PTFE coating does not adversely affect other performance characteristics of the wire. Results demonstrated that the Hi-Torque Connect Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).
Biological Safety	Established through use of same materials and processes	Established through successful use of the same materials and manufacturing process in current 510(k) approved Lake Region Medical products.

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

Sample Size: The document does not specify the exact sample sizes (number of guidewires or test repetitions) for each bench test. It generally refers to "bench tests" being carried out.
Data Provenance: The tests were "In vitro bench tests." The company, Lake Region Medical Limited, is located in Ireland. Therefore, the testing was likely conducted in Ireland or by designated testing facilities on behalf of the Irish manufacturer. The data is prospective as it was generated specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The "ground truth" here is the performance of the guidewire against established engineering and material specifications, and comparison to the predicate device. This is determined by quantitative bench testing, not expert interpretation.

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

This is not applicable as the tests are quantitative bench tests, not qualitative assessments requiring adjudication.

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 is not applicable. This is a physical medical device (guidewire), not an AI algorithm for diagnostic imaging or similar application.

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

This is 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 medical device's performance is based on established engineering and material specifications, as well as the performance characteristics of the previously cleared predicate device (K112381, cleared Nov 3, 2011). The tests also referenced the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". This is a combination of:
* Engineering Specifications: Defined product specifications for the guidewire's physical and mechanical properties.
* Predicate Device Performance: Performance data from a legally marketed device used as a benchmark for substantial equivalence.
* Regulatory Guidance: Adherence to recognized testing methods and performance expectations outlined in FDA guidance.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable.

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 the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

December 17, 2014

Lake Region Medical Mr. Kenneth Walsh Quality Manager Parkmore West Business Park Galway, Ireland

Re: K140536

Trade/Device Name: Hi Torque Connect Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: October 28, 2014 Received: November 3, 2014

Dear Mr. Walsh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to

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proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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/Resourcesfor You/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,

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

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Indications for Use

510(k) Number (if known) K140536

Device Name

Hi Torque Connect Guidewire

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized graphic to the left of the words "Lake Region" in a bold, serif font. Below "Lake Region" is the word "Medical" followed by the registered trademark symbol.

Product: Hi Torque Connect Guidewire Submission Type: Traditional 510(k) Submission Date: March 28, 2014

510(k) Summary

Device Name	Hi Torque Connect Guidewire
Submitters name	Lake Region Medical Limited,
	Butlersland,
	New Ross,
	Co. Wexford,
	Ireland.
Application	Kenneth Walsh
Correspondent	Regulatory Affairs Group Leader
	Lake Region Medical Limited
	Tel: +353 91 385037
	Fax: +353 91 766598
Summary Preparation	28th March 2014
Date
Device Name &	Trade Name:	Hi Torque Connect Guidewire
Classification	Common Name:	Guidewire
	Classification Name:	Catheter, Guidewire
	Device Classification:	Class II, 21 CFR §870.1330
	Product Code:	DQX
Intended Use	Intended Use:
	Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices
	during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as
	femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with
	compatible stent devices during therapeutic procedures.
	Contraindications:
	Hi-Torque wires are not intended for use in the coronary and cerebral vasculature or in
	patients judged not acceptable for percutaneous intervention.
Device Description	The Hi-Torque Connect guidewire range are disposable medical devices designed for
	single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire,
	one end of which is reduced in diameter in a progressive fashion through a centreless
	grinding operation. The profile of this reduced section affords the product a reduced
	area of stiffness and is varied to produce 3 unique levels of support. Each of these 3
	levels of support are provided in 3 different length options (145cm - 300cm)
Predicate Devices	Manufacturer	510k	Date
	Hi Torque Connect Guidewire	K112381	03rd Nov 2011
Principle of Operation	The Hi-Torque Connect guidewire is operated manually by a manual process
Comparison of	This design change involves a change in the PTFE coating formulation applied to the
Technological	proximal shaft of the guidewire. No other changes are proposed to the device.
Characteristics
Performance Testing	In vitro bench tests were carried out to demonstrate equivalence of the existing design
(non-clinical)	to the modified design with reference to the FDAs guidance document "Coronary and
	Cerebrovascular Guidewire Guidance, Jan 1995".
	This testing demonstrates improved coating adhesion properties of the new PTFE coating
	and that the new process for application of the PTFE coating does not adversely affect
	other performance characteristics of the wire.
	The following bench tests were performed:
	- Tensile Strength

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ි Lake Regi Medical®

Product: Hi Torque Connect Guidewire Submission Type: Traditional 510(k) Submission Date: March 28, 2014

-	Torque Strength
-	Dimensional Verification
-	Torque Response
-	Catheter Compatibility
-	Coating Adherence/Coating Integrity
-	Particulate Testing
-	Tip Flexibility
-	PTFE Coating Adhesion
-	PTFE Coating Durability
The results from these performance evaluations demonstrated that the Hi-TorqueConnect Guidewire range met the acceptance criteria defined in the productspecification and performed comparably to the predicate device(s).
Biological Safety of the device has been established through successful use of the samematerials and manufacturing process in current 510(k) approved Lake Region Medicalproduct.
Conclusions	Based on safety and performance testing, technological characteristics and theindications for use for the device, the Hi-Torque Connect Guidewire has beendemonstrated to be appropriate for its intended use and is considered to be substantiallyequivalent 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.