AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610

K093002 · MicroVention, Inc. · KRD · Oct 28, 2009 · Cardiovascular

Device Facts

• Record ID: K093002
• Device Name: AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Azur Peripheral HydroCoil Endovascular Embolization Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

Device Story

Implantable endovascular embolization coil system; consists of coil attached to delivery pusher. Used in interventional radiology to reduce/block blood flow in peripheral vasculature lesions (aneurysms, AVMs, AV fistulae). Delivered via microcatheter to treatment site. Detachment performed by user via external Azur Detachment Controller. System provides mechanical occlusion and gel-based expansion to facilitate embolization. Benefits patient by managing peripheral vascular lesions through minimally invasive endovascular approach.

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspection, simulated use, repositioning time, detachment testing, advancement/retraction, tensile testing, and gel expansion. All tests met established criteria.

Technological Characteristics

Implantable embolization coil with delivery pusher. Operates via mechanical detachment controller. Materials and construction consistent with predicate Azur systems. Sterilized using established processes.

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in peripheral vasculature lesions, including arteriovenous malformations, arteriovenous fistulae, and aneurysms.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Azur Peripheral HydroCoil Endovascular Embolization System- Pushable 35 (K071939)
• Azur Peripheral Hydrocoil Endovascular Embolization System - Detachable 18 (K090168)

Submission Summary (Full Text)

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K093002

# OCT 2 8 2009

## 510(k) Summary

| Trade Name: | Azur Peripheral HydroCoil Endovascular Embolization System -<br>Detachable 35 |
|-----------------|-------------------------------------------------------------------------------|
| Generic Name: | Vascular Embolization Coil |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |

#### Predicate Devices:

| Number | Description | Clearance Date |
|---------|----------------------------------------------------------------------------------|------------------|
| K071939 | Azur Peripheral HydroCoil<br>Endovascular Embolization System-<br>Pushable 35 | January 11, 2008 |
| K090168 | Azur Peripheral Hydrocoil<br>Endovascular Embolization System -<br>Detachable 18 | March 12, 2009 |

### Device Description

The Azur Peripheral HydroCoil Endovascular Embolization System- Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the detachment controller. The detachment controller is activated by the user and this detaches the coil. The Azur coils are designed for use with the Azur Detachment Controller, specifically designed for coil detachment.

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#### Indication For Use

The intended use as stated in the product labeling is as follows:

The Azur Peripheral HydroCoil Endovascular Embolization Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

### Verification and Test Summary Table

| Bench Testing | Result |
|---------------------------------|--------------------------|
| Visual inspection | Met established criteria |
| Dimensional inspection | Met established criteria |
| Simulated use testing | Met established criteria |
| Reposition time | Met established criteria |
| Detachment test | Met established criteria |
| Advancement/Retraction test | Met established criteria |
| Detachment element tensile test | Met established criteria |
| Coil initial tension test | Met established criteria |
| Coil tensile test | Met established criteria |
| Gel expansion | Met established criteria |

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Azur Peripheral HydroCoil Endovascular Embolization System -Detachable 35 coils when compared with the predicate devices, MicroVention Azur Pushable 35 [K071939] and Azur Detachable 18 [K090168].

The devices,

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

In summary, the Azur Detachable 35 coils described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

OCT 2 8 2009

Re: K093002

Azur Peripheral HydroCoil Endovascular Embolization System-Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: September 25, 2009 Received: September 28, 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 such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

R. R. Erickson, M.D.

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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Special 510(k), Azur Detachable 35

# Indications for Use

510(k) Number (if known): ___

Device Name: Azur Peripheral HydroCoil Endovascular Embolization System -Detachable 35

Indications For Use:

The Azur Peripheral HydroCoil Endovascular Embolization Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

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)

Goncurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian/66

(Division Sign, Off) 610(k) Numbe

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