AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

K132083 · MicroVention, Inc. · KRD · Oct 28, 2013 · Cardiovascular

Device Facts

• Record ID: K132083
• Device Name: AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Oct 28, 2013
• 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

The AZUR PURE Peripheral Coil System is an implantable vascular embolization device. It consists of a hydrophilic copolymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The device is delivered to the treatment site via a standard guidewire. The subject device includes a PEEK overcoil modification. It is used by interventional radiologists to reduce or block blood flow in peripheral vessels. The device provides mechanical occlusion to manage vascular lesions, benefiting patients by reducing blood flow to malformations or aneurysms.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included simulated use (prep/insert, track/push, deployment, stability), advancement force, tensile strength at the glue joint, and expansion characteristics. All tests met the same criteria as the predicate device.

Technological Characteristics

Implantable coil system. Materials: Hydrophilic copolymer coil, PEEK overcoil, stainless steel stylet. Delivery: Pushable system via introducer and delivery catheter. Dimensions: Coil OD 3-16 mm, length 6-14 cm. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in peripheral vasculature for 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 PURE Peripheral Coil System, Pushable 35 (K122543)

Submission Summary (Full Text)

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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MicroVention

## 510(K) SUMMARY

Trade Name: AZUR PURE Peripheral Coil System, Pushable 35 Generic Name: Vascular Embolization Device, accessory Classification: Class II, 21 CFR 870.3300 Submitted By: MicroVention, Inc OCT 2 8 2013 1311 Valencia Avenue Tustin, California 92780 U.S.A. Contact: Laraine Pangelina Predicate Device: AZUR PURE Peripheral Coil System, Pushable 35 (K122543) The AZUR PURE is intended to reduce or block the rate of blood Indications for Use: 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. The AZUR PURE Peripheral Coil System, Pushable 35, consists of Device Description: 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.

| Verification & Validation<br>Test Summary: | Test | Result |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------|
| | Simulated Use<br>• Prep/Insert<br>• Track/Push<br>• Deployment<br>• Stability<br>• Overall Performance | Met same criteria as predicate |
| | Advancement Force | Met same criteria as predicate |
| | Tensile Strength at glue joint | Met same criteria as predicate |
| | Expansion Characteristics | Met same criteria as predicate |

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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil

| Predicate / Subject<br>Technological<br>Comparison: | Feature | Predicate Device | Subject Device |
|-----------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------|----------------|
| | Coil shape | Helical | Same |
| | Coil OD (mm) | 3 - 16 | Same |
| | Coil Length (cm) | 6 - 14 | Same |
| | Overcoil | None | PEEK |
| | Delivery Method | Coil housed in an introducer<br>with proximal hub. Pushable<br>delivery using guidewire. | Same |
| | Hydrogel Implant Material | Hydrophilic copolymer | Same |
| | Packaging Configuration | Placed in capped coil<br>introducer, placed on<br>packaging card, into pouch,<br>into box, 5/box | Same |

Summary of Substantial Equivalence: The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

October 28, 2013

MicroVention, Inc. c/o Laraine Pangelina 1311 Valencia Avenue Tustin, CA 92780

Re: K132083

Trade/Device Name: AZUR PURE Peripheral Coil System, Pushable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: September 10, 2013 Received: September 11, 2013

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 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.

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.

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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/CDRH/CDRHOffices/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,

## Bram D. Zuckerman -S

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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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MICH THE MICH CHIP THE MICH

## INDICATIONS FOR USE

K132083 510(k) Number (if known): Device Name: AZUR PURE Peripheral Coil System, Pushable 35 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.

Prescription Use _ X (Per 21 CFR 801.109)

AND/OR

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

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