TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

K093397 · MicroVention, Inc. · DQX · Dec 17, 2009 · Cardiovascular

Device Facts

• Record ID: K093397
• Device Name: TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
• Applicant: MicroVention, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

Device Story

Traxcess 14EX Guidewire and Traxcess Docking Wire are intravascular devices used to facilitate placement of diagnostic or therapeutic catheters. Guidewire features 0.014" stainless steel shaft, tapered distal tip, and stainless steel coils; distal coil has lubricious hydrophilic coating; proximal shaft coated with PTFE and silicone. Docking wire is an accessory used to extend guidewire, featuring nitinol core with PTFE and silicone coating. Used by clinicians in neuro and peripheral vasculature procedures. Device provides steerability for catheter navigation. Bench testing confirms physical attributes, tensile strength, flexibility, torqueability, and attachment integrity.

Clinical Evidence

Bench testing only. Testing included physical attributes, distal tip tensile strength, tip flexibility, distal tip torque strength, coating adherence, torqueability, attachment with docking wire, and docking wire tensile strength. All tests passed.

Technological Characteristics

0.014" stainless steel shaft; stainless steel coils; nitinol core (docking wire); hydrophilic coating (distal tip); PTFE and silicone coating (proximal shaft). Mechanical device; no energy source or software.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate selective placement of diagnostic or therapeutic catheters. Contraindicated for use in coronary arteries.

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

• Traxcess 0.014" Hydrophilic Guidewire (K080863)
• Runthrough NS Extension Wire (K080563)

Submission Summary (Full Text)

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1093397

# 510(k) Summary

# DEC 1 7 2009

| Trade Name: | Traxcess 14EX Guidewire and Traxcess Docking Wire |
|-----------------|------------------------------------------------------------------------|
| Generic Name: | Guidewire |
| Classification: | Class II, 21 CFR 807.1330 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |

#### Predicate Devices:

| Number | Description | Clearance Date |
|---------|---------------------------------------|----------------|
| K080863 | Traxcess 0.014" Hydrophilic Guidewire | April 7, 2008 |
| K080563 | Runthrough NS Extension Wire | March 20, 2008 |

### Device Description:

The Traxcess 14EX Guidewire consists of a 0.014" stainless steel shaft and a tapered The Traxcess 14EA Guidewire consisted organism and stainless steel coils. The distal coil minton the contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE and silicone.

The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It The Traxess Docking Which an use assist with a nitinol pipe and is coated with PTFE and silicone.

## Indication For Use:

The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

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## Verification and Test Summary Table

| Bench Testing | Result |
|-------------------------------|--------|
| Physical attributes | Pass |
| Distal tip tensile strength | Pass |
| Tip flexibility | Pass |
| Distal tip torque strength | Pass |
| Coating adherence | Pass |
| Torqueability | Pass |
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Traxcess 14EX Guidewire and Traxcess Docking Wire when compared with the predicate devices.

The devices,

- I Have the same intended use,
- 트 Use the same operating principle,
- 메 Incorporate the same basic design,
- I Use similar construction and material,
- Are packaged and sterilized using same material and processes.

In summary, the Traxcess 14EX Guidewire and Traxcess Docking Wire described in this submission is, in our opinion, substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Microvention Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

DEC 1 7 2009

Re: K093397

Trade Device Name: Traxcess 14EX Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 11, 2009 Received: December 14, 2009

#### Dear Ms. Gong:

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.

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### Page 2 - Ms. Naomi Gong

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k), Traxcess EX

MicroVention, Inc.

# Indications for Use

510(k) Number (if known): _ K 0 93397

Traxcess 14EX Guidewire and Traxcess Docking Wire Device Name:

Indications For Use:

The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kog 3397

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