HEADWAY 27 MICROCATHETER

K110813 · MicroVention, Inc. · DQY · Aug 5, 2011 · Cardiovascular

Device Facts

• Record ID: K110813
• Device Name: HEADWAY 27 MICROCATHETER
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Device Story

Headway 27 Microcatheter is a single-lumen percutaneous catheter for accessing small, tortuous vasculature. Device features semi-rigid proximal section transitioning to flexible distal tip; dual radiopaque markers for fluoroscopic visualization; hydrophilic coating for lubricity; luer fitting for accessory attachment. Operated by physicians in clinical settings (e.g., interventional radiology/cardiology). Device is introduced over a steerable guidewire to deliver contrast media or therapeutic agents like occlusion coils. Enables navigation through complex vascular anatomy to target sites; facilitates precise delivery of diagnostic/therapeutic materials; improves procedural access to peripheral, coronary, and neurovascular systems.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility verification. Bench testing included surface/physical attributes, tensile strength, leakage, burst pressure, simulated use, compatibility, flow rate, kink resistance, flexural fatigue, torque, and DMSO compatibility. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization/irritation (ISO 10993-10), hemocompatibility (ISO 10993-4), and systemic toxicity (ISO 10993-11). All tests passed.

Technological Characteristics

Single-lumen percutaneous catheter. Features hydrophilic coating. Radiopaque markers for visualization. Dimensions: 0.027" ID, 0.037" OD. Materials and sterilization processes are identical to predicate. Biocompatibility compliant with ISO 10993-4, 5, 10, 11.

Indications for Use

Indicated for general intravascular use in peripheral, coronary, and neurovasculature 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 21 Microcatheter (K093160)

Submission Summary (Full Text)

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# Killogi 3

| Trade Name: | Headway 27 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 |
| Date: | 2011Mar23 |
| Predicate Device: | Headway 21 Microcatheter (K093160) |

### 510(k) Summary

AUG - 5 2011

#### Device Description:

The Headway 27 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 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

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| 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 |
| Torque test | Pass |
| DMSO compatibility | Pass |

#### Verification and Test Summary Table

| Biocompatibility | Result |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxcitiy (ISO 10993-5)<br>- MEM elution assay<br>- Agarose overlay | Pass |
| Sensitization/Irritation (ISO 10993-10)<br>- Guinea pig maximization sensitization<br>- Intracutaneous reactivity | Pass |
| Hemocompatibility (ISO 10993-4)<br>- Hemolysis<br>- Prothrombin time assay<br>- Complement activation C3a and SC5b-9<br>- 4 hour thromboresistance in dogs | Pass |
| Systemic Toxicity (ISO 10993-11)<br>- Systemic toxicity<br>- Rabbit pyrogen test | Pass |

#### Technological Comparison

The Headway 27 utilizes the same fundamental technology, basic design, operating principle and intended use as the predicate device with the exception of the outer and inner diameter dimensions. The inner diameter was increased to 0.027" from 0.021" and the outer diameter was increased to 0.037" from 0.030".

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#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 27 Microcatheter when compared with the predicate device, Headway 21 Microcatheter (K093160).

The devices,

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

In summary, the Headway 27 Microcatheter described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/3/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 an abstract image of an eagle.

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 1311 Valencia Avenue Tustin, CA 92780

Re: K110813

Trade/Device Name: Headway 27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 20, 2011 Received: July 21, 2011

AUG - 5 2011

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 noté: 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.

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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 (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/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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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Headway 27 Microcatheter Device Name:

Indications For Use:

The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Prescription Use AND/OR X (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)

Cardiovascular Devices

510(k) Number K110813

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