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 Description

The AZUR Peripheral Coil System - Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. 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 pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).

AI/ML Overview

The sponsor, MicroVention, Inc., submitted an amendment to their 510(k) for the AZUR Peripheral Coil System - Detachable 18. This device is a vascular embolization device intended to reduce or block blood flow in peripheral vasculature. The device has the same indications for use as predicate devices, MicroVention AZUR Detachable 18 HydroCoil (K090168) and AZUR Pushable 35 (K071939). In conclusion, the AZUR Peripheral Coil System - Detachable 18 is substantially equivalent to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

Bench Testing	Acceptance Criteria	Reported Device Performance
Dimensional Measurement	Met established criteria	Met established criteria
Tracking	Met established criteria	Met established criteria
Repositioning / Deployment	Met established criteria	Met established criteria
Detachment Test	Met established criteria	Met established criteria

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The provided text details bench testing, not clinical studies with patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth for bench testing is typically based on engineering specifications and measurement standards, not expert clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This information is relevant for clinical studies with subjective assessments, not for bench testing.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a vascular embolization device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the bench testing was based on "established criteria," which likely refers to engineering specifications, design parameters, and established industry standards for dimensional accuracy, device tracking, repositioning/deployment functionality, and detachment effectiveness.

8. The sample size for the training set

Not applicable. This information is not relevant for the type of bench testing described.

9. How the ground truth for the training set was established

Not applicable. This information is not relevant for the type of bench testing described.

Summary

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K120630 page 1 of 2

MAR 2 8 2012

510(K) Summary of Safety and Effectiveness

Trade Name:	AZUR Peripheral Coil System - Detachable 18
Generic Name:	Vascular Embolization Device
Classification:	Class II, 21 CFR 870.3300
Submitted By:	MicroVention, Inc.1311 Valencia AvenueTustin, California U.S.A.
Contact:	Cynthia Valenzuela

Predicate Device:

Number	Description	Clearance Date
K090168	AZUR Peripheral HydroCoilEndovascular Embolization System -Detachable 18	March 12, 2009
K071939	AZUR Peripheral HydroCoilEndovascular Embolization System -Pushable 35	January 11, 2008

Device Description

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Indication For Use

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

Verification and Test Summary Table

Bench Testing	Result
Dimensional Measurement	Met established criteria
Tracking	Met established criteria
Repositioning / Deployment	Met established criteria
Detachment Test	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 18 line extension coils when compared with the predicate devices, MicroVention AZUR Detachable 18 HydroCoil (K090168) and AZUR Pushable 35 (K071939).

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 18 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 & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

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

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

MAR 2 8 2012

Re: K120630

Trade/Device Name: AZUR Peripheral Coil System – Detachable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device · Regulatory Class: Class II Product Code: KRD Dated: February 29, 2012 Received: March 1, 2012

Dear Ms. Valenzuela:

We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave reviewed your 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 assession to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered price to may 20, 1977, 11:5 accordance with the provisions of the Federal Food, Drug, de nees mat have been room 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, attreflers, visions 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 advised that I Driv issualles or our device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must of any I caerar statutes and regirements, including, but not limited to: registration and listing (21 Comply with an the Fee 5 requirements 801); medical device reporting (reporting of medical CI K I all 607), lucemig (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.S. Whilden

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

510(k) Number (if known): K120630

Device Name: AZUR Peripheral Coil System - Detachable 18

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)

Cuzhilleben

ision of Cardiovascular Devices

K120630 510(k) Number

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
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.(b)
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).