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- 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 proximal end of the delivery pusher is inserted to the detachment controller. The detachment controller is activated by the user and this detaches the coil. The Azur coils are designed for use with the Azur Detachment Controller, specifically designed for coil detachment.

AI/ML Overview

Here's an analysis of the provided text regarding the Azur Peripheral HydroCoil Endovascular Embolization System - Detachable 35, specifically focusing on acceptance criteria and study details.

Based on the provided 510(k) summary, this submission is for a medical device (vascular embolization coil), not a software or AI-based diagnostic tool. Therefore, many of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and submission.

The "study" described is a bench testing verification, which is typical for physical medical devices to demonstrate safety and performance against established criteria, typically in a laboratory setting. There is no mention of clinical trials, patient data, or expert consensus being used for this specific 510(k) submission.

Here's the breakdown of the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Visual inspection	Met established criteria
Dimensional inspection	Met established criteria
Simulated use testing	Met established criteria
Reposition time	Met established criteria
Detachment test	Met established criteria
Advancement/Retraction test	Met established criteria
Detachment element tensile test	Met established criteria
Coil initial tension test	Met established criteria
Coil tensile test	Met established criteria
Gel expansion	Met established criteria

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in the provided text for each specific bench test. The phrase "Met established criteria" implies that a sufficient number of tests were performed according to a pre-defined protocol.
Data Provenance: The tests are "Bench Testing," implying a laboratory or engineering environment. There is no indication of country of origin for data or if it's retrospective/prospective, as it's not based on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of expert consensus or pathology, is not relevant for the bench testing of a physical medical device. The "ground truth" here is the engineering specifications and performance standards established for the device.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers/experts, which is not relevant for bench testing of a device's physical and functional properties.

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 physical embolization coil, not an AI software. No MRMC study was performed or is relevant for this submission.

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

Not Applicable. This device is a physical embolization coil, not an algorithm. No standalone performance evaluation for an algorithm was performed.

7. The type of ground truth used

Engineering Specifications and Performance Standards: For bench testing, the "ground truth" is defined by pre-established engineering specifications, performance requirements, and established industry standards for vascular embolization coils. The device's performance is measured against these objective, quantifiable criteria.

8. The sample size for the training set

Not Applicable. This pertains to machine learning models. This submission describes a physical device, not an AI system.

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

Not Applicable. This pertains to machine learning models.

Summary

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K093002

OCT 2 8 2009

510(k) Summary

Trade Name:	Azur Peripheral HydroCoil Endovascular Embolization System -Detachable 35
Generic Name:	Vascular Embolization Coil
Classification:	Class II, 21 CFR 870.3300
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.
Contact:	Naomi Gong

Predicate Devices:

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

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 inspection	Met established criteria
Simulated use testing	Met established criteria
Reposition time	Met established criteria
Detachment test	Met established criteria
Advancement/Retraction test	Met established criteria
Detachment element tensile test	Met established criteria
Coil initial tension test	Met established criteria
Coil tensile test	Met established criteria
Gel expansion	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 -Detachable 35 coils when compared with the predicate devices, MicroVention Azur Pushable 35 [K071939] and Azur Detachable 18 [K090168].

The devices,

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

In summary, the Azur Detachable 35 coils described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. The text is in uppercase letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MicroVention, Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

OCT 2 8 2009

Re: K093002

Azur Peripheral HydroCoil Endovascular Embolization System-Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: September 25, 2009 Received: September 28, 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 such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. R. Erickson, M.D.

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 Detachable 35

Indications for Use

510(k) Number (if known): ___

Device Name: Azur Peripheral HydroCoil Endovascular Embolization System -Detachable 35

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)

Goncurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian/66

(Division Sign, Off) 610(k) Numbe

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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).