HEADWAY 21 MICROCATHETER, MODEL: MC212150S

K093160 · MicroVention, Inc. · DQY · Nov 5, 2009 · Cardiovascular

Device Facts

• Record ID: K093160
• Device Name: HEADWAY 21 MICROCATHETER, MODEL: MC212150S
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Headway 21 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Device Story

Headway 21 Microcatheter is a single-lumen catheter designed for navigation through small, tortuous vasculature. Device features semi-rigid proximal section transitioning to flexible distal tip; dual radiopaque markers for fluoroscopic visualization; hydrophilic polymer coating for lubricity; luer fitting for accessory attachment. Operated by physicians in clinical settings (e.g., interventional radiology, cardiology, neurosurgery) under fluoroscopic guidance. Device is introduced over a steerable guidewire to access target vessels. Once positioned, it serves as a conduit for delivering diagnostic contrast media or therapeutic occlusion coils. Facilitates minimally invasive access to complex vascular anatomy; enables targeted delivery of agents/devices to treat vascular conditions.

Clinical Evidence

Bench testing only. Testing included surface and physical attributes, distal and hub tensile strength, leakage (liquid and air), static and dynamic burst pressure, simulated use, compatibility with other devices, flow rate, kink resistance, and catheter flexural fatigue. All tests passed.

Technological Characteristics

Single-lumen percutaneous catheter; semi-rigid proximal section with flexible distal tip; hydrophilic polymer coating; dual radiopaque markers; luer hub fitting. Sterilized device. No software or electronic components.

Indications for Use

Indicated for general intravascular use in peripheral, coronary, and neuro vasculature for infusion of diagnostic agents (contrast media) and therapeutic agents (occlusion coils).

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Headway 17 Microcatheter (K083343)

Submission Summary (Full Text)

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K093160

## 510(k) Summary

NOV - 5 2009

| Trade Name: | Headway 21 Microcatheter |
|-----------------|------------------------------------------------------------------------|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|--------------------------|------------------|
| K083343 | Headway 17 Microcatheter | December 4, 2008 |

## Device Description:

The Headway 21 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.

### Indication For Use:

The Headway 21 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

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#### Verification and Test Summary Table

| Bench Testing | Result |
|-----------------------------------|--------|
| Surface and physical attributes | Pass |
| Distal tensile strength | Pass |
| Hub tensile strength | Pass |
| Leakage (liquid and air) | Pass |
| Static and dynamic burst pressure | Pass |
| Simulated use | Pass |
| Compatibility with devices | Pass |
| Flow rate | Pass |
| Kink resistance | Pass |
| Catheter flexural fatigue | Pass |

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 21 Microcatheter when compared with the predicate device, Headway 17 Microcatheter (K083343).

The devices,

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

In summary, the Headway 21 Microcatheter 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 -WO66-G609 Silver Spring. MD 20993-0002

MicroVention Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 75 Columbia, Suite A Aliso Viejo, CA 92656

## NOV - 5 2009

Re: K093160

> Trade/Device Name: Headway 21 Microcatheter Common Name: catheter, percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: October 5, 2009 Received: October 6, 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.

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

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Page 2 - Ms. Naomi Gong

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 (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/CDRH0ffices/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 yours.

Duna R. bulmer

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

Enclosure

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MicroVention, Inc.

# Indications for Use

510(k) Number (if known):_K093/60

Device Name: Headway 21 Microcatheter

Indications For Use:

The Headway 21 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Donna R. Vachines
(Division City, or

(Division Sign-Off Division of Cardiovascular Devi

510(k) Number

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