MERIDIAN GUIDEWIRE

K093681 · Ev3 Neurovascular · DQX · Jan 26, 2010 · Cardiovascular

Device Facts

• Record ID: K093681
• Device Name: MERIDIAN GUIDEWIRE
• Applicant: Ev3 Neurovascular
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.

Device Story

Meridian Guidewire is a stainless steel guidewire featuring a radiopaque distal coil and hydrophilic coating. Used by physicians during diagnostic or therapeutic intravascular procedures to facilitate selective catheter placement in peripheral, visceral, and cerebral vasculature. Includes a torque device for manipulation and an introducer for catheter hub/hemostasis valve insertion. Operates as a manual tool; no electronic or automated components.

Clinical Evidence

No clinical data. Evidence consists of non-clinical performance testing, including biocompatibility, extensive bench testing, in vitro design validation, shelf-life testing, and assessment of bioburden, pyrogen, EtO residuals, and sterility.

Technological Characteristics

Stainless steel core with soldered radiopaque distal coil. Distal portion features hydrophilic coating. Includes torque device and guidewire introducer. Manual operation; no energy source or software.

Indications for Use

Indicated for general intravascular use to aid in selective catheter placement within peripheral, visceral, and cerebral vasculature during diagnostic or therapeutic procedures.

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

• SilverSpeed Guidewire (K993257)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

・

### 510(k) Summary .

JAN 2 6 2010

KO93681

| 510(k) Owner: | Micro Therapeutics dba ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Deborah Baker-Janis<br>Senior Regulatory Affairs Specialist,<br>Regulatory Affairs<br>Telephone: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | 25 November 2009 |
| Trade Name of Device: | Meridian Guidewire |
| Common Name of Device: | Catheter Guidewire |
| Classification of Device: | DQX, Catheter Guidewire (21 CFR 870.1330), Class II |
| Predicate Device: | SilverSpeed Guidewire (K993257) |
| Device Description: | The Meridian Guidewire is a stainless steel guidewire with a<br>radiopaque, distal coil. The distal portion of the guidewire is<br>hydrophilically coated. Included within the sterile pouch is a torque<br>device to assist in guidewire manipulation and a guidewire introducer to<br>ease the introduction of the guidewire into the catheter hub and/or<br>hemostasis valve. |
| Intended Use: | The Meridian Guidewire is indicated for general intravascular use to aid<br>in the selective placement of catheters in the peripheral, visceral, and<br>cerebral vasculature during diagnostic and/or therapeutic procedures. |
| Summary of Technological Characteristics: | The Meridian Guidewire and the predicate device both consist of a core<br>guidewire with overlying soldered distal coil. The materials and<br>dimensions of the Meridian Guidewire are similar to those of the<br>predicate device. The packaging materials and materials comprising<br>the accessories are identical to those of the predicate device. |
| Non-Clinical Performance Data: | Biocompatibility testing, extensive bench testing, and an in vitro design<br>validation study were performed as well as shelf-life testing and an<br>assessment of bioburden, pyrogen, EtO residuals, and sterility. |
| Conclusion: | The Meridian Guidewire is substantially equivalent to the SilverSpeed<br>Guidewire based on the successful completion of non-clinical testing,<br>identical principles of operation and indications for use, similarities in<br>the design, materials, and dimensions of the device, identical<br>accessories and final packaging, and similar design specifications. |

3.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 bird, possibly an eagle or similar avian creature, with its wings spread in a dynamic, abstract form. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and the country it represents.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 6 2010

Micro Therapeutics, Inc. c/o Ms. Deborah Baker-Janis Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92681

Re: K093681

Trade/Device Name: Meridian Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: November 25, 2009 Received: November 27, 2009

Dear Ms. Baker-Janis: .

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.

{2}------------------------------------------------

Page 2 - Ms. Deborah Baker-Janis

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 forth in 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

vuna R. V. Muniz

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

#### 2. Indications for Use Statement

Indications for Use

510(k) Number (if known): KO9 368 |

Device Name: Meridian Guidewire

Indications for Use: The Meridian Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, and cerebral vasur ture during diagnostic and/or therapeutic 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)

| Dumar. Voondurmense of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------------|--|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |

510(k) Number_Ko.93681

Page 1 of 1

CONFIDENTIAL

PAGE 4