The Azur Detachable 18 Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.

The coils are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.

Device Description

The Azur 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 provided text describes a 510(k) premarket notification for the Azur Detachable 18 Coil System, a vascular embolization device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing, rather than a clinical study evaluating device performance against specific acceptance criteria in a human patient population. Therefore, many of the requested elements for a study proving device meets acceptance criteria are not directly available in this document.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The acceptance criteria are generally "Met established criteria" for various bench tests. Specific quantitative thresholds for these criteria are not detailed in this summary document.

Bench Testing	Acceptance Criteria (Implied)	Reported Device Performance
Visual Inspection	Met established criteria	Met established criteria
Dimensional Measurement	Met established criteria	Met established criteria
Tracking	Met established criteria	Met established criteria
Repositioning- Deployment	Met established criteria	Met established criteria
Placement - Stability	Met established criteria	Met established criteria
Detachment Test	Met established criteria	Met established criteria

Note: The provided document is a 510(k) summary, which often omits the detailed quantitative acceptance criteria and raw data that would be present in the full 510(k) submission.

Study Information

The document describes bench testing, not a human clinical study. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial to prove safety and effectiveness against specific clinical endpoints.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: Not applicable as this is bench testing, not clinical data from a specific country or population. It's an in-vitro evaluation.
- Retrospective or Prospective: Not applicable as it's bench testing.
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. Bench testing does not involve human experts establishing a "ground truth" in the clinical sense. The "ground truth" for bench tests would be defined by engineering specifications and standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to bench testing. The evaluation is against engineering specifications.
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 diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in a clinical sense. The "ground truth" for the bench tests would be the established engineering specifications and performance parameters for the device, and comparison to the predicate device's known performance.
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable for the reasons stated above.

Summary

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K090168

MicroVention Inc.

Special 510(k), Azur Detachable 18

510(k) Summary

Trade Name:	Azur Detachable 18	MAR 1 2 2009
Generic Name:	Vascular Embolization Device
Classification:	Class II, 21 CFR 882.5950
Submitted By:	MicroVention, Inc75 ColumbiaAliso Viejo, California U.S.A.
Contact:	Florin Trusset

Predicate Device:

Number	Description	Clearance Date
K050954	MicroVention Inc., HydroCoil EmbolicSystem (HES)	June 28, 2005

Device Description

Indication For Use

The Azur Detachable 18 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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Verification and Test Summary Table

Bench Testing	Result
Visual Inspection	Met established criteria
Dimensional Measurement	Met established criteria
Tracking	Met established criteria
Repositioning- Deployment	Met established criteria
Placement - Stability	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 Detachable 18 line extension coils when compared with the predicate device MicroVention Azur Detachable 18 hydrocoil that was cleared to market under the MicroVention HydroCoil Embolic System (HES) K050954

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 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

MAR 1 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. % Florin Truuvert, RAC Senior Director, Worldwide Regulatory Affairs 75 Columbia, Suite A Aliso Viejo, California 92656

Re: K090168

Trade/Device Name: Azur Detachable 18 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: February 27, 2009 Received: March 2, 2009

Dear Florin Truuvert:

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.

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

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Page 2 - Florin Truuvert, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Lri Ahmed. for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Azur Detachable 18

Indications For Use:

The Azur Detachable Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Daniel Kuora for MXKM March 11, 2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K090118

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).