AZUR PUSHABLE 18 & 35 SYSTEM

K130577 · MicroVention, Inc. · KRD · Jun 17, 2013 · Cardiovascular

Device Facts

• Record ID: K130577
• Device Name: AZUR PUSHABLE 18 & 35 SYSTEM
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Jun 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The AZUR Pushable 18 & 35 Coil System is a vascular embolization device used to reduce or block blood flow in peripheral vessels. The device consists of a platinum alloy (Pt/W: 92/8) coil coated with a hydrogel polymer and an additional over-coil. The implant is attached to a delivery pusher; a battery-powered detachment controller is used to release the coil from the pusher once positioned. The device is operated by interventional radiologists in a clinical setting. By inducing embolization, the coil helps manage conditions such as aneurysms and arteriovenous malformations. The healthcare provider uses fluoroscopic guidance to place the coil; the resulting occlusion reduces blood flow to the target lesion, providing therapeutic benefit.

Clinical Evidence

Bench testing only. Testing included simulated use and advancement/retraction force measurements, which met established criteria.

Technological Characteristics

Materials: Platinum alloy (Pt/W: 92/8) wire, hydrogel polymer, DYMAX adhesive. Principle: Mechanical embolization via coil deployment. Energy: Battery-powered electrical detachment controller. Form factor: Pushable coil system (18 & 35). Sterilization: Not specified (standard processes).

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in peripheral vasculature, specifically for the 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

• HydroCoil Embolic System (HES) – HydroFrame (K071939)
• AZUR Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 (K091882)
• MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) (K050954)

Submission Summary (Full Text)

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K130577

Image /page/0/Picture/1 description: The image contains the logo for MicroVention TERUMO. The logo consists of a stylized graphic on the left, resembling a series of curved lines or waves. To the right of the graphic is the text "MicroVention" in a clean, sans-serif font, with "TERUMO" appearing in a smaller font size directly below it.

#### 510(K) Summary

JUN 1 7 2013

Trade Name: AZUR Coil System - Pushable 18 & 35 Generic Name: Vascular Embolization Device Class II, 21 CFR 870.3300 Classification:

Submitted By: MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.

Contact: Cynthia Valenzuela

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|-------------------------------------------------------------------------------------|----------------|
| K071939 | HydroCoil Embolic System (HES) –<br>HydroFrame | 22APR2010 |
| K091882 | AZUR Peripheral HydroCoil<br>Endovascular Embolization<br>Coil System - Pushable 18 | 08JUL2009 |
| K050954 | MicroPlex Coil System (MCS) and<br>HydroCoil Embolic System (HES) | 28JUN2005 |

#### Device Description

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The AZUR Pushable 18 & 35 coils are made of platinum alloy (Pt/W: 92/8) with an outer layer of hydrogel polymer with an added over-coil. The over-coil is comprised of a 0.00125" platinum alloy (Pt/W: 92/8) wire which is wound over the hydrogel polymer and two ends are bonded to the main coil with the same DYMAX adhesive used in the existing AZUR Pushable 18 & 35 coils. The over-coil materials and manufacturing processes are also the same as those used in the manufacture of the HES (K0509054) coils.

The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery ousher

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Image /page/1/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo consists of a stylized graphic to the left of the text "MicroVention" in a sans-serif font. Below "MicroVention" is the word "TERUMO" in a bolder, sans-serif font. The overall design is simple and corporate.

#### Indication For Use

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

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

#### Verification and Test Summary Table

| Bench Testing | Result |
|--------------------------------|--------------------------|
| Simulated Use | Met established criteria |
| Advancement / Retraction Force | Met established criteria |

#### Summary of Substantial Equivalence . . . . . . . . .

The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Coil System - Pushable 18 & 35 line extension coils when compared with the predicate devices, MicroVention AZUR Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 & 35 (K071939, K091882) and HydroCoil Embolic System (K050954).

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 Coil System - Pushable 18 & 35 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

June 17, 2013

Microvention, Inc. Attention: Cynthia Valenzuela 1311 Valencia Avenue Tustin. CA 92780

Re: K130577

Trade/Device Name: Azur Pushable 18 and 35 System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: May 17, 2013 Received: May 22, 2013

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 adülteration." Please note: CDRH döes 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.

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

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#### Page 2 - [Cynthia Valenzuela]

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Bram D.亿元gKerman -S

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

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### Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: AZUR Peripheral Coil System (Pushable) 18 & 35 System

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 (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)

# Brai 2013