AZUR DETACHABLE 35

K122316 · MicroVention, Inc. · KRD · Aug 29, 2012 · Cardiovascular

Device Facts

• Record ID: K122316
• Device Name: AZUR DETACHABLE 35
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Aug 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZUR Peripheral 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 Coil System - Detachable 35 is a vascular embolization device consisting of an implantable coil attached to a delivery pusher. Used in interventional radiology, the device is delivered to the target site via a microcatheter. A battery-powered detachment controller, operated by the clinician, triggers the release of the coil from the pusher. The device functions to reduce or block blood flow in peripheral vessels to treat malformations, fistulae, aneurysms, and other lesions. The system provides a mechanical means for embolization, aiding in the management of vascular pathologies.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional measurement, simulated use, device repositioning, device detachment, and advance/retract force, all of which met established criteria.

Technological Characteristics

Implantable coil with delivery pusher; battery-powered detachment controller. Materials and construction are similar to the predicate device. Sterilization processes are identical to the predicate. No software or complex algorithm involved.

Indications for Use

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

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 – Detachable 35 (K093002)

Submission Summary (Full Text)

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# 1223110

## 510(K) Summary

| Trade Name: | AZUR Peripheral Coil System - Detachable 35 | AUG 2 9 2012 |
|-----------------|-------------------------------------------------------------------------|--------------|
| Generic Name: | Vascular Embolization Device | |
| Classification: | Class II, 21 CFR 870.3300 | |
| Submitted By: | MicroVention, Inc.<br>1311 Valencia Avenue<br>Tustin, California U.S.A. | |
| Contact: | Cynthia Valenzuela | |

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|----------------------------------------------------------------------------------|------------------|
| K093002 | AZUR Peripheral HydroCoil<br>Endovascular Embolization System –<br>Detachable 35 | October 08, 2009 |

#### Device Description

The AZUR Peripheral Coil 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 detachment controller is activated by the user and this detached the coil. The detachment controller utilizes battery power to detach the coils from the delivery pusher.

### Indication For Use

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

The AZUR Peripheral 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.

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Image /page/1/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo consists of a stylized graphic to the left of the text "MicroVention" in a larger font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder font. The graphic is a series of curved lines that resemble a fingerprint or sound waves.

#### Verification and Test Summary Table

| Bench Testing | Result |
|-------------------------|--------------------------|
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Device Repositioning | Met established criteria |
| Device Detachment | Met established criteria |
| Advance / Retract Force | Met established criteria |

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Peripheral Coil System - Detachable 35 line extension coils when compared with the predicate devices, MicroVention AZUR Detachable 35 (K093002).

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 AZUR Peripheral Coil System - Detachable 35 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

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

AUG 2 9 2012

MicroVention, Inc. c/o Ms. Cynthia Valenzuela International Regulatory Affairs 1311 Valencia Avenue Tustin, CA 92780

Re: K122316

Trade/Device Name: AZUR Peripheral Coil System - Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: July 25, 2012 Received: August 1, 2012

Dear Ms. Valenzuela:

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 note: 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. Cynthia Valenzuela

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/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,

M.G. Willen

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

K122316 510(k) Number (if known): __

Device Name: AZUR Peripheral Coil System - Detachable 35

Indications For Use:

The AZUR 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 AND/OR (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)

MR. Hillen

(Division Sign-Off) Division of Cardiovascular Devices

K 122316 510(k) Number