MERIT LAUREATE HYDROPHILIC GUIDE WIRE

K092303 · Merit Medical Systems, Inc. · DQX · Oct 27, 2009 · Cardiovascular

Device Facts

• Record ID: K092303
• Device Name: MERIT LAUREATE HYDROPHILIC GUIDE WIRE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.

Device Story

The Merit Hydrophilic Guide Wire is a medical device used to facilitate the placement of other devices during diagnostic and interventional procedures. It consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The device is available in various lengths with straight or angled tip configurations. It is intended for use by clinicians in clinical settings. The device functions as a mechanical aid to navigate vasculature or anatomical pathways, allowing for the subsequent delivery of diagnostic or therapeutic devices. It provides a low-friction surface to assist in smooth insertion and positioning.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy were demonstrated through performance testing based on industry standards and protocols.

Technological Characteristics

Jacketed core wire with hydrophilic coating. Available in straight and angled tip configurations in various lengths. Class II device (21 CFR 870.1330).

Indications for Use

Indicated for facilitating device placement during diagnostic and interventional procedures in patients requiring such clinical interventions.

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

• Radiofocus® Glidewire® (K863138)
• Hydrophilic Coated Guide Wire (K000011)

Submission Summary (Full Text)

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K092303

Merit Medical Systems, Inc.
Merit Hydrophilic Guide Wire Traditional Premarket Notification 510(k) Section 5
510(k) Summary

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| Section 5 | | |
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| 510(k) Summary | | OCT 2 7 2009 |
| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Contact Person: | Susan Christensen |
| | Date of Preparation: | July 28, 2009 |
| | Registration Number: | 1721504 |
| Subject<br>Device | Trade Name: | Merit Hydrophilic Guide Wire |
| | Common/Usual Name: | Guide Wire |
| | Classification Name: | Catheter Guide Wire |
| Predicate<br>Devices | Trade Name: | Radiofocus® Glidewire® |
| | Classification Name: | Catheter Guide Wire |
| | Premarket Notification: | K863138 |
| | Manufacturer: | Terumo Medical Corporation |
| | Trade Name: | Hydrophilic Coated Guide Wire |
| | Classification Name: | Catheter Guide Wire |
| | Premarket Notification: | K000011 |
| | Manufacturer: | Lake Region Medical |
| Classification | Class II<br>21 CFR § 870.1330, 74 DQX<br>Division of Cardiovascular Devices | |
| Intended Use | The Merit Hydrophilic Guide Wire is intended to facilitate the<br>placement of devices during diagnostic and interventional<br>procedures. | |
| Device<br>Description | The Merit Hydrophilic Guide Wire consists of a jacketed core wire<br>with a hydrophilic coating applied to the jacket.<br>The wire will be offered with straight and angled tip<br>configurations in various lengths. | |
| Technological<br>Characteristics | Technological characteristics of the subject Merit Hydrophilic Guide<br>Wire are substantially equivalent to those of the predicate, the<br>currently marketed Terumo Radiofocus® Glidewire® [K863138], and<br>the Lake Region Medical Hydrophilic Coated Guide Wire [K000011]. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514<br>of the Food, Drug and Cosmetic Act for these devices. However, a<br>battery of tests was performed according to protocols based on the<br>requirements of industry standards and guidances and were shown<br>to meet the acceptance criteria that were determined to demonstrate<br>the safety and efficacy of the device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety, and performance<br>testing, the subject Merit Hydrophilic Guide Wire meets the<br>requirements that are considered essential for its intended use and is<br>substantially equivalent to the predicate devices, the currently<br>marketed Radiofocus® Glidewire® manufactured by Terumo Medical<br>Corporation and the Hydrophilic Coated Guide Wire manufactured by<br>Lake Region Medical. | |

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Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Traditional Premarket Notification 510(k)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## OCT 2 7 2009

Merit Medical Systems, Inc. c/o Ms. Susan Christensen 1600 West Merit Parkway South Jordan, UT 84095

Re: K092303

> Trade/Device Name: Merit Hydrophilic Guide Wire Common Name: Catheter Guidewire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: July 28, 2009 Received: July 29, 2009

Dear Ms. Christensen:

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.

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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Page 2 - Ms. Susan Christensen

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wmat.

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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## Section 4

## Indications for Use Statement

510(k) Number (if known):

长092303

Device Name: Merit Hydrophilic Guide Wire

Indications for Use:

The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.F.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k092303