The Azur Peripheral HydroCoil Endovascular Embolization 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 HydroCoil® Endovascular Embolization System- Pushable 18 coils consist of an implantable coil packaged in an introducer along with a stylet. The stainless steel stylet is used to deploy the coil from the introducer into the delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. The Azur™ coil is platinum-based with a hydrogel polymer layer.

AI/ML Overview

The provided text describes a medical device, the Azur™ Peripheral HydroCoil® Endovascular Embolization System - Pushable 18, and its regulatory clearance process, specifically related to substantial equivalence to predicate devices. It does not contain information about a study that assesses the device's performance against specific quantitative acceptance criteria or its effectiveness in a clinical setting.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be inferred and what is not available based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Visual Inspection	Met established criteria
Dimensional Measurement	Met established criteria
Simulated Use	Met established criteria
Advancement force	Met established criteria
Distal tip tensile test	Met established criteria
Proximal tip tensile test	Met established criteria
Body coil tensile test	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)
This information is not provided in the document. The "Verification and Test Summary Table" lists various bench tests, but does not specify sample sizes or data provenance.

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)
This information is not provided as there is no mention of a clinical test set or human expert involvement in establishing ground truth. The tests listed are bench tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reviewed test set or adjudication.

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
This information is not provided. This document describes a medical device for embolization, not an AI-assisted diagnostic tool or an imaging device directly involving human readers for interpretation. Therefore, an MRMC study as described is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This device is not an algorithm but a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the listed bench tests would be the established engineering specifications or performance standards for each test. For example, for "Visual Inspection," the ground truth would be that the device has no visible defects according to a defined spec. For "Dimensional Measurement," the ground truth would be that the dimensions fall within a specified range. These are not clinical "ground truths" like pathology or expert consensus.

8. The sample size for the training set
This information is not provided. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
This information is not provided as there is no AI/ML training set.

Summary

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K091882 page 1 of 2

510(k) Summary

JUL - 8 2009

Trade Name:	Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18
Generic Name:	Vascular Embolization Coil
Classification:	Class II, 21 CFR 870.3300
Submitted By:	MicroVention, Inc75 ColumbiaAliso Viejo, California U.S.A.
Contact:	Naomi Gong

Predicate Devices:

Number	Description	Clearance Date
K071939	Azur™ Peripheral HydroCoil®Endovascular Embolization System-Pushable 18	January 11, 2008
K050954	HydroCoil Embolic System	June 28, 2005

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
Visual Inspection	Met established criteria
Dimensional Measurement	Met established criteria
Simulated Use	Met established criteria
Advancement force	Met established criteria
Distal tip tensile test	Met established criteria
Proximal tip tensile test	Met established criteria
Body coil tensile test	Met established criteria

Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18 coils when compared with the predicate devices, MicroVention Azur Pushable 18 coils [K071939] and HydroCoil Embolic System (HES) [K050954].

The devices,

Have the same intended use, 트
Use the same operating principle. 트
Incorporate the same basic design,
트 Use similar construction and material,
러 Are packaged and sterilized using same material and processes.

In summary, the Azur Pushable 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 seal of the Department of Health & Human Services (HHS). The seal is circular and features an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2009

MicroVention, Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 75 Columbia, Suite A Alison Viejo, CA 92656

Re: K091882

Azur Peripheral HydroCoil Endovascular Embolization Coil System - Pushable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II (two) Product Code: KRD Dated: June 22, 2009 Received: June 24, 2009

Dear Ms. Gong:

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.

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. Naomi Gong

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/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by (eference 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

una R. bachner

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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Special 510(k), Azur Pushable 18

MicroVention, Inc.

Indications for Use

6091882 510(k) Number (if known):

Device Name:

Azur™ Peripheral HydroCoil® Endovascular Embolization System -Pushable 18

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

sumer R. V.

(Division Sign-Off) (Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices 7 -

510(k) Number K09183

Page 1 of 1

Page 18 of 119

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).