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 Peripheral Coil System - Detachable 35 consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The detachment controller is activated by the user and this detached the coil. The detachment controller utilizes battery power to detach the coils from the delivery pusher.

AI/ML Overview

This 510(k) submission describes the AZUR Peripheral Coil System - Detachable 35, a vascular embolization device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study.

Here's an analysis of the provided information, addressing your specific points:

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

Test Category	Acceptance Criteria	Reported Device Performance
Dimensional Measurement	Established criteria (not specified)	Met established criteria
Simulated Use	Established criteria (not specified)	Met established criteria
Device Repositioning	Established criteria (not specified)	Met established criteria
Device Detachment	Established criteria (not specified)	Met established criteria
Advance / Retract Force	Established criteria (not specified)	Met established criteria

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

The document explicitly states "Bench Testing" for the verification and test summary. This indicates that the tests were conducted in a laboratory setting, not on human or animal subjects. Therefore, there is no "test set" in the context of clinical data, no country of origin of data, and it is neither retrospective nor prospective in the clinical sense. The sample sizes for each bench test are not specified in the provided document.

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)

Since the study involved bench testing and not clinical evaluation or human interpretation of data, there were no experts used to establish ground truth in the way you describe for a clinical test set. The acceptance criteria for the bench tests would have been pre-defined engineering or quality standards, likely set by the manufacturer's engineers and quality control personnel.

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

Not applicable. As this was bench testing, there was no adjudication method as typically applied to a clinical test set involving expert review. The performance was measured against pre-defined engineering specifications.

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

No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (vascular embolization coil), not an AI-powered diagnostic or decision support system. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm.

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

For the bench testing, the "ground truth" would be the established engineering specifications or performance parameters that the device was designed to meet. These criteria are not detailed in the summary but are implied to have been "established criteria" that the device "Met."

8. The sample size for the training set

Not applicable. This document describes the testing and regulatory submission for a physical medical device. The concept of a "training set" is relevant for machine learning or AI models, which are not involved here.

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

Not applicable, as there is no training set for this type of device.

Summary

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1223110

510(K) Summary

Trade Name:	AZUR Peripheral Coil System - Detachable 35	AUG 2 9 2012
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
K093002	AZUR Peripheral HydroCoilEndovascular Embolization System –Detachable 35	October 08, 2009

Device Description

Indication For Use

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

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.

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Image /page/1/Picture/0 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 larger font. Below "MicroVention" is the word "TERUMO" in a smaller, bolder font. The graphic is a series of curved lines that resemble a fingerprint or sound waves.

Verification and Test Summary Table

Bench Testing	Result
Dimensional Measurement	Met established criteria
Simulated Use	Met established criteria
Device Repositioning	Met established criteria
Device Detachment	Met established criteria
Advance / Retract Force	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 35 line extension coils when compared with the predicate devices, MicroVention AZUR Detachable 35 (K093002).

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 35 Coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

AUG 2 9 2012

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

Re: K122316

Trade/Device Name: AZUR Peripheral Coil System - Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: July 25, 2012 Received: August 1, 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.

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Page 2 -- Ms. Cynthia Valenzuela

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.

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/CDRH0ffices/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.G. Willen

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

K122316 510(k) Number (if known): __

Device Name: AZUR Peripheral Coil System - Detachable 35

Indications For Use:

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)

MR. Hillen

(Division Sign-Off) Division of Cardiovascular Devices

K 122316 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).