HEADWAY 17 ADVANCED MICROCATHETER

K101542 · MicroVention, Inc. · DQY · Aug 6, 2010 · Cardiovascular

Device Facts

• Record ID: K101542
• Device Name: HEADWAY 17 ADVANCED MICROCATHETER
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Headway 17 Advanced 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

Single lumen microcatheter designed for navigation through small, tortuous vasculature over a steerable guidewire. Features semirigid proximal section transitioning to flexible distal tip; dual radiopaque markers for fluoroscopic visualization; hydrophilic coating for lubricity. Physician-operated in clinical settings. Used to deliver diagnostic contrast media or therapeutic occlusion coils. Provides access to target anatomy; facilitates therapeutic intervention. Benefits patient by enabling minimally invasive access to complex vascular sites.

Clinical Evidence

Bench testing included surface/physical attributes, tensile strength, tip retention, leakage, burst pressure, simulated use, compatibility, kink resistance, flexural fatigue, stiffness, coating, particulate analysis, and flow rate. All bench tests met specifications. Acute animal study demonstrated performance comparable to predicate device. Biocompatibility testing (ISO 10993) passed for cytotoxicity, sensitization, irritation, hemocompatibility, and systemic toxicity.

Technological Characteristics

Single lumen catheter; polyether block amide (with barium sulfate), stainless steel, nylon, PTFE construction. Hydrophilic coating. Dual radiopaque Pt/Ir markers. Distal OD 1.7 Fr; proximal OD 0.031". Compatible with 0.014" guidewires. Sterile, single-use. Standards: ISO 10555-1, ISO 10993-1.

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

• MicroVention - Headway 17 Microcatheter (K083343)
• Boston Scientific, Excelsior SL-10 Preshaped Microcatheter (K042568)

Submission Summary (Full Text)

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### 510(k) Summary

| Product Name: | Headway 17 Advanced 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.<br>714-247-8000 |
| AUG 0 6 2010 | |
| Contact: | Naomi Gong |
| Date Prepared: | February 26, 2010 |

#### Predicate Devices:

| Number | Description | Clearance Date |
|---------|---------------------------------------------------------------|------------------|
| K083343 | MicroVention - Headway 17<br>Microcatheter | December 4, 2008 |
| K042568 | Boston Scientific, Excelsior SL-10<br>Preshaped Microcatheter | October 15, 2004 |

### Device Description:

The Headway 17 Advanced Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semirigid 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. The catheters are packaged individually with a variety of preshaped tips.

### Indication For Use:

The Headway 17 Advanced 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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## Standards Used for Device Testing:

- ISO 10555-1, Sterile, single-use, intravascular catheters .
- . ISO 10993-1, Biological evaluation of medical devices

## Testing Summary:

| Bench Testing | Result |
|-------------------------------------------------------------------------------------------|----------------------------------------------------|
| Surface and physical attributes | Met same specifications as predicate |
| Tensile strength | Met same specifications as predicate |
| Tip shape and retention | Met same specifications as predicate |
| Leakage (liquid and air) | Met same specifications as predicate |
| Static and dynamic burst pressure | Met same specifications as predicate |
| Simulated use | Met same specifications as predicate |
| Compatibility with devices | Met same specifications as predicate |
| Kink resistance | Met same specifications as predicate |
| Catheter flexural fatigue | Met same specifications as predicate |
| Catheter stiffness | Met same specifications as predicate |
| Hydrophilic coating | Met same specifications as predicate |
| Particulate measurement analysis | Met same specifications as predicate |
| Packaging testing | Met same specifications as predicate |
| Insertion tool performance | Met specification - previously tested on predicate |
| Flow rate | Met specification - previously tested on predicate |
| Hub testing | Met specification - previously tested on predicate |
| Corrosion resistance | Met specification - previously tested on predicate |
| Animal Testing | Result |
| Device performance was evaluated in an acute<br>animal study compared to predicate device | Comparable performance to predicate device |
| Biocompatibility Testing (ISO-10993-1) | Result |
| Cytotoxcitiy (ISO 10993-5) | Pass |
| Sensitization/Irritation (ISO 10993-10) | Pass |
| Hemocompatibility (ISO 10993-4) | Pass |
| Systemic Toxicity (ISO 10993-11) | Pass |

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## Technological comparison:

.

| | Predicate Device (K833434) | 510(k) Subject Device |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Headway 17 Advanced<br>microcatheter is intended for general<br>intravascular use, including the<br>peripheral, coronary and<br>neurovasculature- for the infusion of<br>diagnostic and therapeutic agents. | Same |
| Size | Proximal = 2.4Fr<br>Distal = 1.9Fr | Proximal = Same<br>Distal = 1.7 Fr |
| Material | Catheter body: polyether block amide,<br>stainless steel, nylon, PTFE<br>Marker band: Pt/Ir<br>Hub: nylon<br>Strain relief: polyether block amide<br>Introducer sheath: polyether block amide<br>Shaping mandrel: stainless steel | Same with barium sulfate<br>incorporated in polyether block<br>amide segment |
| Distal Shaft Length (Shapeable Length) | 11 cm | Same |
| Proximal ID/OD | ID = .0170" min<br>OD = .031" | Same |
| Distal ID/OD | ID = .0170" min<br>OD = .025" | ID = Same<br>OD = .022" |
| No. of Markers | 2 | Same |
| Coating | Hydrophilic Coating | Same |
| Effective Length | 150 cm | Same |
| Tip Configuration | Straight - Steam Shapeable by physician<br>prior to use | Same as K042568- Boston<br>Scientific Excelsior SL-10:<br>Preshaped tips -with the option<br>of secondary shaping for proper<br>adjustment to the anatomy prior<br>to use. |
| Guidewire compatibility | 0.014 " wires or smaller | Same |
| Method of supply | Sterile and single use | Same |

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### Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 17 Advanced Microcatheter when compared with the predicate devices, MicroVention-Headway 17 Microcatheter (K083343) and Boston Scientific-Excelsior SL-10 Preshaped Microcatheter (K042568).

The devices,

- Have the same intended use, 다
- 피 Use the same operating principle,
- 이 Incorporate the same basic design,
- . Use similar construction and material,
- Are sterilized using same methods and processes. ●

In summary, the Headway 17 Advanced Microcatheter as described in this submission is substantially equivalent to the predicate devices

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the eagle's feathers. The image is in black and white.

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

AUG 1 7 2010

MicroVention, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technologies Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K101542

Trade Name: Headway 17 Advanced Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: July 20, 2010 Received: July 21, 2010

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 6, 2010.

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 Foond, Or to 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 - Mr. Mark Job

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" (21 CFR 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/ReportalProblem/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,

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

K101542 510(k) Number (if known):

"Aug D 6 zono

Device Name: Headway 17 Microcatheter

Indications For Use:

The Headway 17 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)

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