MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE

K072552 · Merit Medical Systems, Inc. · DQX · Dec 14, 2007 · Cardiovascular

Device Facts

• Record ID: K072552
• Device Name: MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.

Device Story

Guide Wire Torque Device is a manual accessory for interventional procedures; assists in manipulation and placement of hydrophilic and other guide wires (.018 to .038 inches). Device features single-handed operation; user depresses actuator to thread wire through lumen; releasing actuator engages stainless steel spring to grip wire. Used by clinicians in interventional settings to provide torque and control during wire navigation. Benefits include improved handling and precise positioning of guide wires during vascular or other interventional access.

Clinical Evidence

Bench testing only. Biocompatibility testing for cytotoxicity was performed and passed.

Technological Characteristics

Materials: ABS plastic body, polypropylene core, stainless steel spring. Mechanism: Tension spring-based gripping. Dimensions: Accommodates .018 to .038 inch guide wires. Connectivity: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for facilitating guide wire manipulation during interventional procedures for patients requiring guide wire placement.

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

• MYSHELL, Alligatork Torque Device (K040498)

Submission Summary (Full Text)

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# SECTION 5: 510(k) SUMMARY

| SUBMITTER: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095 |
|----------------------------|----------------------------------------------------------------------------------|
| CONTACT: | William D. Jordan |
| DATE PREPARED: | September 7, 2007 |
| TRADE OR PROPRIETARY NAME: | Guide Wire Torque Device |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, 870.1330 |
| PREDICATE DEVICES: | MYSHELL, Alligatork Torque Device, K040498 |

K072552
P. Lot 1
DEC 1 4 2007### DEVICE DESCRIPTION:

The Guide Wire Torque Device is a guide wire accessory developed to assist in the manipulation and placement of hydrophilic and other typical guide wires during interventional procedures. It accomodates guide wires from .018 to .038 inches and is composed of three components: 1. An ABS plastic body; 2. A polypropylene "core" which grips the guide wire; and 3. A stainless steel spring which supplies the force to grip the guide wire.

The design of the Guide Wire Torque device allows single-handed operation. The wire gripping actuator is depressed while the guide wire is threaded through the device's lumen. When the Guide Wire Torque Device is located on the guide wire in the appropriate location, the actuator is released alllowing the device to grip the guide wire.

#### INTENDED USE:

The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.

#### TECHNOLOGICAL CHARACTERISTICS:

All of the component materials found in the Guide Wire Torque Device have been used in legally marketed Merit devices and were found safe for use. The Guide Wire Torque Device has been evaluated and passed appropriate biocompatibility testing for Cytotoxicity. Both the Guide Wire Torque Device and the predicate are mechanically similar. Both use a tension spring mechanism to provide a grip on the guide wire.

Merit believes that the prior use of the component materials of the Guide Wire Torque Device in legally marketed devices, the performance data provided, and the biocompatibility data provided demonstrate that the Guide Wire Torque Device is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

Merit Medical Systems, Inc. c/o Mr. William D. Jordan Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K072552

> Trade/Device Name: Guide Wire Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 12, 2007 Received: November 14, 2007

Dear Mr. Jordan:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. William D. Jordan

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Cls.K

Bram D. Zuckerman, M.D. દિશ 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Guide Wire Torque Device Device Name:

Indications for Use:

The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.

Prescription Use _ X (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)

LLS.M

diovascular Devices

510(k) Number_ 6072552