AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

K122543 · MicroVention, Inc. · KRD · Nov 28, 2012 · Cardiovascular

Device Facts

• Record ID: K122543
• Device Name: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Nov 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZUR PURE 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

AZUR PURE Peripheral Coil System is an implantable all-polymer embolization coil; housed in an introducer; deployed via stainless steel stylet through a delivery catheter using a standard guidewire. Used in interventional radiology for peripheral vascular lesions (aneurysms, AVMs, AV fistulae). Device reduces/blocks blood flow to the target site. Operated by interventional radiologists in clinical settings. Benefits include effective vessel occlusion for management of peripheral vascular pathologies.

Clinical Evidence

No clinical data. Evidence consists of bench testing (simulated use, dimensional characteristics, tensile strength, advancement force, FTIR, hydrostability, MRI compatibility, electrical conductivity, packaging validation, sterilization validation, shelf life, biocompatibility) and acute/chronic animal testing. All tests met established criteria.

Technological Characteristics

Implantable all-polymer coil; hydrophilic copolymer hydrogel; stainless steel stylet; pushable delivery system. Dimensions: AZUR 18 (3-10mm OD, 2-20cm length), AZUR 35 (4-15mm OD, 4-14cm length). Sterilization and biocompatibility validated.

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in peripheral vasculature to manage 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 Coil System, Pushable 18 and 35 (K071939, K091882)

Submission Summary (Full Text)

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K122543 page 1 of 2 15 , MicroVention

# 510(K) SUMMARY

# NOV 2 8 2012

| Trade Name: | AZUR PURE Peripheral Coil System, Pushable 18 & 35 |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| Generic Name: | Vascular Embolization Coil |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California 92780 U.S.A. |
| Contact: | Laraine Pangelina |
| Predicate Device: | AZUR Peripheral HydroCoil Endovascular Embolization Coil System,<br>Pushable 18 and 35 (K071939, K091882) |

#### Device Description:

The AZUR PURE Peripheral Coil System, Pushable 18 & 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.

#### Indications for Use:

The AZUR PURE 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.

| Test | Result |
|--------------------------------|--------------------------|
| Simulated Use | Met established criteria |
| Dimensional Characteristics | Met established criteria |
| Tensile Strength | Met established criteria |
| Advancement Force | Met established criteria |
| FTIR | Met established criteria |
| HydroStability | Met established criteria |
| MRI Compatibility | Met established criteria |
| Electrical Conductivity | Met established criteria |
| Packaging Validation | Met established criteria |
| Sterilization validation | Met established criteria |
| Shelf Life | Met established criteria |
| Biocompatibility | Met established criteria |
| Acute & Chronic Animal Testing | Met established criteria |

### Verification and Validation Test Summary:

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MicroVentour
TERUMO

AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)

| | Predicate Devices (K071939, K091882 | AZUR PURE, 510(k) Subject Device |
|------------------------------|--------------------------------------------------------------------------------------------|------------------------------------|
| Coil Shape | Helical | Same |
| Coil OD (mm) | AZUR 18: 2 - 10<br>AZUR 35: 3 - 16 | AZUR 18: 3 - 10<br>AZUR 35: 4 - 15 |
| Coil Length (cm) | AZUR 18: 2 - 14<br>AZUR 35: 4 - 14 | AZUR 18: 2 - 20<br>AZUR 35: 4 - 14 |
| Delivery Method | Coil housed in an introducer with proximal<br>hub. Pushable delivery using guidewire. | Same |
| Hydrogel Implant<br>Material | Hydrophilic copolymer | Same |
| Packaging<br>Configuration | Placed in capped coil introducer, placed on<br>packaging card, into pouch, into box, 5/box | Same |

Technological comparison, subject and predicate device:

#### Summary of Substantial Equivalence:

The AZUR PURE Peripheral Coil System, Pushable 18 & 35 is substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal

#### CONFIDENTIAL

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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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 8 2012 -

Microvention, Inc. % Laraine Pangelina 1311 Valencia Ave Tustin, CA 92780 US

Re: K122543

Trade/Device Name: AZUR PURE peripheral coil system Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 2, 2012 Received: November 8, 2012

Dear Ms. Pangelina:

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 for ass stated or 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 r ou may a 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived a determination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or any I oderal statuation and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fat 607), fucemig (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Laraine Pangelina .

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 If you desire specific advice for your do riters offices/CDRH/CDRHOffices/ucm115809.htm for go to into://www.ida.gov/rt8odio.org/w/index.php?tice of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CDRH Ball the Center for Devices und Radionogicular by reference to premarket notification" (21CFR Part flore the regulation entined, "Miordinance 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 Tou thay obtain other generers, 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,

Matthew G. Hillebrenner

for Bram D. Zuckerman, M.D.

Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiològical Health

Enclosure

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AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)

## INDICATIONS FOR USE

510(k) Number (if known):

K122543 · ·

Device Name:

Indications for Use:

AZUR PURE Peripheral Coil System, Pushable 18 & 35

The AZUR PURE 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 (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. of Killeber

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K122543