HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE

K140536 · Lake Region Medical · DQX · Dec 17, 2014 · Cardiovascular

Device Facts

• Record ID: K140536
• Device Name: HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
• Applicant: Lake Region Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

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.

Device Story

The Hi-Torque Connect Guidewire is a disposable, single-use device designed to facilitate the placement of percutaneous devices and stents during peripheral artery PTA procedures. It consists of a 0.018" diameter stainless steel core wire with a PTFE coating. The core wire undergoes centerless grinding to create a tapered profile, providing three distinct levels of support and varying stiffness. The device is operated manually by a clinician in a clinical setting. By providing a track for interventional devices, it assists in navigating peripheral vasculature, potentially improving procedural success and patient outcomes. The current iteration features a modified PTFE coating formulation on the proximal shaft to improve coating adhesion properties.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluations included tensile strength, torque strength, dimensional verification, torque response, catheter compatibility, coating adherence/integrity, particulate testing, tip flexibility, and PTFE coating durability. Results demonstrated that the device met all product specifications and performed comparably to the predicate device.

Technological Characteristics

Disposable 0.018" diameter stainless steel core wire; PTFE-coated proximal shaft; centerless ground tapered profile for variable stiffness/support. Available in lengths 145cm–300cm. Manual operation. Biocompatibility established via materials and processes identical to previously cleared Lake Region Medical products.

Indications for Use

Indicated for patients undergoing percutaneous transluminal angioplasty (PTA) in peripheral arteries (femoral, popliteal, infra-popliteal) to facilitate placement of percutaneous devices or stents. Contraindicated for use in coronary or cerebral vasculature or in patients not acceptable for percutaneous intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hi Torque Connect Guidewire (K112381)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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#### FOR FDA USE ONLY

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

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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: [phone] | | |
| | Fax: [phone] | | |
| 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-Torque<br>Connect Guidewire range met the acceptance criteria defined in the product<br>specification and performed comparably to the predicate device(s). | |
| Biological Safety of the device has been established through successful use of the same<br>materials and manufacturing process in current 510(k) approved Lake Region Medical<br>product. | |
| Conclusions | Based on safety and performance testing, technological characteristics and the<br>indications for use for the device, the Hi-Torque Connect Guidewire has been<br>demonstrated to be appropriate for its intended use and is considered to be substantially<br>equivalent to the predicate devices. |