SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY

K124007 · Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · DQX · Mar 7, 2013 · Cardiovascular

Device Facts

• Record ID: K124007
• Device Name: SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
• Applicant: Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SilverSpeed™, Mirage™, X-celerator™ Exchange, and X-pedion™ Hydrophilic Guidewires are 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

Stainless steel guidewire with radiopaque platinum distal coil; distal portion features hydrophilic coating. X-celerator Exchange model includes proximal PTFE coating to facilitate interventional device exchange while maintaining anatomical position. Used by physicians in clinical settings for catheter placement in peripheral, visceral, and cerebral vasculature. Device aids navigation through vasculature to support diagnostic or therapeutic interventions. Modifications include changes to base coat polymerization and removal of Brown Oxide pigment.

Clinical Evidence

No clinical or animal testing performed. Evidence consists of biocompatibility testing (USP Physiochemical, ISO MEM Elution, ISO Sensitization, ISO Intracutaneous Reactivity, ISO Acute Systemic Injection, Material Mediated Rabbit Pyrogen, ASTM Hemolysis, Complement Activation) and bench testing (visual inspection, tip buckling, tip shapeability, tip retention, coating adherence, friction, torque response) and 36-month accelerated aging shelf-life testing.

Technological Characteristics

Stainless steel core; radiopaque platinum distal coil; hydrophilic distal coating; PTFE proximal coating (Exchange model). Biocompatibility per ISO 10993 standards. Bench testing for mechanical performance (torque, friction, tip flexibility).

Indications for Use

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.

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.

Submission Summary (Full Text)

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#### Device Description:

The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

- Change in the degree of polymerization with the base coat . material.
- . Elimination of Brown Oxide pigment from base coat material.

Intended Use:

### Non-Clinical Performance Data:

The Hydrophilic 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.

The following tests were performed to support the changes to the Hydrophilic Guidewires:

#### Biocompatibility Testing

- USP Physiochemical Extraction .
- Cytotoxicity: ISO MEM Elution Using L-929 Mouse Fibroblast Cells
- Sensitization: ISO Guinea Pig Maximization Sensitization . Test
- ISO Intracutaneous Reactivity Test .
- ISO Acute Systemic Injection Test .
- Material Mediated Rabbit Pyrogen Test .
- ASTM Hemolysis Assay Direct Contact Method .
- Complement Activation C3a and SC5b-9 Assay .

Four Hour Thromboresistance Evaluation in Dogs . Bench Testing

- Visual Inspection .
- Tip Buckling (Flexibility) .
- Tip Shapeability .
- Tip Retention .
- . Coating Adherence.
- Friction Test .
- Torque Response

Shelf-life Testing

- 36-month Accelerated Aging .
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.

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## Substantial Equivalence Determination

The information presented in the 510(k) shows that the Hydrophilic Guidewires are substantially equivalent to the predicate devices previously in regards to the identical indications for use, device design, similar device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

March 7,2013

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

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Analia Staubly Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K124007

Trade/Device Name: SilverSpeed™, Mirage™, X-celerator™ Exchange, and X-pedion™ Hydrophilic Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 21, 2012 Received: December 26, 2012

Dear Ms. Staubly:

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.

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 - Analia Staubly

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 yours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K124007

SilverSpeed™, Mirage™, X-celerator™ Exchange, and Device Name: X-pedion™ Hydrophilic Guidewires

Indications For Use:

The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are 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.

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)

Victor Krauthamer -S 2013.03.05 18:38:20 -05'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number _ K124007

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