TRAXCESS DOCKING WIRE

K093647 · MicroVention, Inc. · DQX · Feb 24, 2010 · Cardiovascular

Device Facts

• Record ID: K093647
• Device Name: TRAXCESS DOCKING WIRE
• Applicant: MicroVention, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Traxcess Docking Wire is an accessory guidewire extension; used to extend Traxcess guidewires. Device consists of stainless steel shaft with nitinol pipe; coated with PTFE and silicone. Operated by clinicians in clinical settings to facilitate selective placement of diagnostic or therapeutic catheters within neuro and peripheral vasculature. Device provides mechanical support and steerability for catheter navigation. Benefits include improved procedural efficiency during catheter exchange or placement. Not for coronary artery use.

Clinical Evidence

Bench testing only. Testing included attachment strength, tensile strength, and simulated use testing (tracking, supportability, microcatheter compatibility/exchange, and repositioning). All tests passed.

Technological Characteristics

Stainless steel shaft with nitinol pipe; PTFE and silicone coating. Guidewire accessory. Sterilized using standard processes. No software or electronic components.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate 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

• Runthrough NS Extension Wire (K080563)

Submission Summary (Full Text)

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# FEB 2 4 2010 1093647

## 510(k) Summary

| Trade Name: | Traxcess Docking Wire |
|-----------------|------------------------------------------------------------------------|
| Generic Name: | Guidewire |
| Classification: | Class II, 21 CFR 870.1330 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|------------------------------|----------------|
| K080563 | Runthrough NS Extension Wire | March 20, 2008 |

### Device Description:

The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It consists of a stainless steel shaft with a nitinol pipe and is coated with PTFE and silicone.

#### Indication For Use:

The 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 |
|----------------------------------------------------------------------------------------------------------|--------|
| Attachment with docking wire | Pass |
| Docking wire tensile strength | Pass |
| Simulated use testing<br>- Tracking, supportability, microcatheter compatibility/exchange, repositioning | Pass |

#### Summary of Substantial Equivalence

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

The device

- Uses the same operating principle, .
- Incorporates the same basic design,
- Uses similar construction and material, ■
- Is packaged and sterilized using same material and processes. .

In summary, the 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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with medicine and healthcare.

#### Public Health Service

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

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

FEB 2 4 2010

Re: K093647

Trade/Device Name: Traxcess Docking Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2010 Received: January 15, 2010

#### 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. 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 - Ms. Gong

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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

R. hamer

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

Enclosure

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## Indications for Use

510(k) Number (if known):_Kuji5647

Device Name: Traxcess Docking Wire

Indications For Use:

ﺘﻨ ﺗ

The Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Traxcess Docking Wire can be used with Traxcess guidewires to facilitate the 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)

NURSERY Rhymes

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number k093647

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