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 Description

The AZUR CX Coil System - Detachable 18 Coils are made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths which have the gel on all the loops. The implant segment is then attached to the delivery 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

Here's an analysis of the provided text regarding the Azur CX Coil System, focusing on the acceptance criteria and supporting studies.

Based on the provided text, the device is a Class II Vascular Embolization Device and the submission is a 510(k) premarket notification for a line extension. This means the primary goal of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, rather than proving novel effectiveness or efficacy through extensive clinical trials.

Therefore, the "acceptance criteria" and "studies" are primarily focused on bench testing to show that the new device performs similarly and safely to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Bench Testing)	Reported Device Performance
Simulated Use	Met established criteria
Detachment	Met established criteria
Advancement / Retraction Force	Met established criteria

Note: The document states that the data demonstrates "technological similarity and equivalency" and that the device "is, in our opinion, substantially equivalent" to the predicate devices. The specific quantitative acceptance thresholds for "Met established criteria" are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document only mentions "Bench Testing" and does not provide details on the number of units tested for each criterion.
Data Provenance: The studies are described as "Bench Testing," implying in-vitro, laboratory-based testing conducted by the manufacturer, MicroVention, Inc. (located in Tustin, California, U.S.A.). The data is prospective in the sense that MicroVention performed these tests for the submission, but they are not clinical studies on human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. For a 510(k) submission based on bench testing for substantial equivalence, the "ground truth" is typically established by engineering specifications, validated test methods, and comparison against the performance of predicate devices. There is no mention of external human experts establishing ground truth for these bench tests in the provided document.

4. Adjudication Method for the Test Set

Not Applicable. As the “studies” are in-vitro bench tests, there is no clinical data or expert review process that would require an adjudication method like those used for clinical trials or image interpretation. The testing results are likely evaluated against predetermined engineering specifications and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is a type of clinical study typically used to evaluate the diagnostic accuracy of a medical imaging device when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a vascular embolization device, and the provided document only discusses bench testing for substantial equivalence, not a clinical effectiveness study of diagnostic image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a physical medical implant (a coil system for embolization), not an algorithm or AI software that would have a "standalone" performance. The "device" itself is the instrument being evaluated.

7. Type of Ground Truth Used

Engineering Specifications and Predicate Device Performance. For the bench tests ("Simulated Use," "Detachment," "Advanccment / Retraction Force"), the "ground truth" or standard for acceptance would be based on:
- Pre-defined engineering requirements and specifications for the device's mechanical and functional properties.
- Demonstrating performance comparable to the predicate devices identified (K120630 and K071939).

8. Sample Size for the Training Set

Not Applicable. This is not an AI or machine learning device that requires a "training set." The device is a physical medical implant.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (As above, no training set is relevant for this type of device submission.)

Summary

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K12338

Image /page/0/Picture/1 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 sans-serif font. Below "MicroVention" is the word "TERUMO" in a blocky, sans-serif font. The overall design is clean and professional.

· 510(K) Summary

Trade Name:	AZUR CX Coil System - Detachable 18
Generic Name:	Vascular Embolization Device	NOV 2 8 2012
Classification:	Class II, 21 CFR 870.3300
Submitted By:	MicroVention, Inc.1311 Valencia AvenueTustin, California U.S.A.
Contact:	Cunthia Valenziela

Predicate Device:

Number	Description	Clearance Date
K120630	AZUR Peripheral HydroCoilEndovascular Embolization System -Detachable 18	March 28, 2012
K071939	HydroCoil Embolic System (HES) -HydroFrame	April 22, 2010

Device Description

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Image /page/1/Picture/0 description: The image shows the logo for MicroVention TERUMO. The logo consists of a circular graphic on the left, followed by the text "MicroVention" in a serif font. Below "MicroVention" is the word "TERUMO" in a blocky, sans-serif font. The overall design is simple and professional.

Indication For Use

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

Verification and Test Summary Table

Bench Testing	Result
Simulated Use	Met established criteria
Detachment	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 CX Coil System - Detachable 18 line extension coils when compared with the predicate devices, MicroVention HydroCoil Embolic System -HydroFrame (K100454) and AZUR Detachable 18 (K120630).

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 CX 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

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

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

NOV 2 8 2012

Re: K123384

Trade/Device Name: AZUR CX Coil System - Detachable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 31, 2012 Received: November 2, 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.

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

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Page 2 – [Ms. Cynthia Valenzuela]

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 OF R 809), good maart 820); and if applicable, the electronic forth in the quality systems (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 17 you desire specific acrites to: your Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.fadi.gov/rroungov/ Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may other buner generers, 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,

Matthew G. Hillebrennér

for 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):

AZUR CX Peripheral Coil System (Detachable) Device Name:

Indications For Use:

The AZUR System is intended to reduce or block the rate of blood flow in vessels of the I w HDON byton is intended for use in the interventional radiologic management of perfoneral rasemand or it is a neverysms, and other lesions of the lesions of the peripheral vasculature.

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Prescription Use __ AND/OR X (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)

W.S. Heeler

(Division Sign-O Division of Cardiovascular Devices

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).