AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM

K091882 · MicroVention, Inc. · KRD · Jul 8, 2009 · Cardiovascular

Device Facts

• Record ID: K091882
• Device Name: AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Jul 8, 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

The Azur Peripheral HydroCoil Endovascular Embolization System-Pushable 18 is an implantable vascular embolization device. It consists of a platinum-based coil with a hydrogel polymer layer, packaged with an introducer and a stainless steel stylet. The device is used in interventional radiology to reduce or block blood flow in peripheral vessels. The coil is delivered to the target site via a delivery catheter using a standard guidewire; the stylet facilitates deployment from the introducer. By physically occupying the vessel space and inducing flow reduction, the device aids in the management of malformations, fistulae, and aneurysms. It is intended for use by trained clinicians in a clinical setting.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual inspection, dimensional measurement, simulated use, advancement force, and tensile testing (distal tip, proximal tip, and body coil), all of which met established criteria.

Technological Characteristics

Platinum-based coil with hydrogel polymer layer; stainless steel stylet; delivery via catheter/guidewire; mechanical embolization principle; sterile, single-use device.

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 18 (K071939)
• HydroCoil Embolic System (K050954)

Submission Summary (Full Text)

{0}------------------------------------------------

K091882 page 1 of 2

## 510(k) Summary

# JUL - 8 2009

| Trade Name: | Azur™ Peripheral HydroCoil® Endovascular Embolization System -<br>Pushable 18 |
|-----------------|-------------------------------------------------------------------------------|
| Generic Name: | Vascular Embolization Coil |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc<br>75 Columbia<br>Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |

### Predicate Devices:

| Number | Description | Clearance Date |
|---------|---------------------------------------------------------------------------------|------------------|
| K071939 | Azur™ Peripheral HydroCoil®<br>Endovascular Embolization System-<br>Pushable 18 | January 11, 2008 |
| K050954 | HydroCoil Embolic System | June 28, 2005 |

## Device Description

The Azur™ Peripheral HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.

{1}------------------------------------------------

#### 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 Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Advancement force | Met established criteria |
| Distal tip tensile test | Met established criteria |
| Proximal tip tensile test | Met established criteria |
| Body coil tensile test | 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 -Pushable 18 coils when compared with the predicate devices, MicroVention Azur Pushable 18 coils [K071939] and HydroCoil Embolic System (HES) [K050954].

The devices,

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

In summary, the Azur Pushable 18 coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and features an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 8 2009

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

Re: K091882

Azur Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II (two) Product Code: KRD Dated: June 22, 2009 Received: June 24, 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.

{3}------------------------------------------------

## 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/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by (eference 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/cdrb/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

una R. bachner

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

Enclosure

{4}------------------------------------------------

Special 510(k), Azur Pushable 18

MicroVention, Inc.

# Indications for Use

6091882 510(k) Number (if known):

Device Name:

Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sumer R. V.

(Division Sign-Off) (Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices 7 -

510(k) Number K09183

Page 1 of 1

Page 18 of 119