MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V

K093919 · MicroVention, Inc. · HCG · Jan 21, 2010 · Neurology

Device Facts

• Record ID: K093919
• Device Name: MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is 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 embolizations in the peripheral vasculature.

Device Story

MicroPlex Coil System (Cosmos) is a neurovascular embolization device; consists of platinum alloy 3D spherical coils; attached to V-Trak delivery pusher via polymer filament; pusher features radiopaque markers for positioning. Operated by physician in clinical setting; proximal end of pusher connects to handheld, battery-powered V-Grip Detachment Controller; activation of controller detaches implant coil. Device used to permanently obstruct blood flow to aneurysms or vascular malformations; provides mechanical occlusion to benefit patients with neurovascular or peripheral vascular abnormalities.

Clinical Evidence

Bench testing only. Tests included visual inspection, dimensional measurement, simulated use, detachment testing, detachment zone tensile testing, advancement/retraction force, coil-to-coupler weld tensile testing, and spring constant. All tests met established criteria.

Technological Characteristics

Platinum alloy implant coils; 3D spherical structure; V-Trak delivery pusher with polymer filament attachment; radiopaque positioning markers; handheld battery-powered V-Grip Detachment Controller; Class II device.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion within the neurovascular system; and arterial/venous embolizations in the peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891)

Submission Summary (Full Text)

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K093919

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JAN 2 1 2010

| Trade Name: | MicroPlex Coil System - Cosmos |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California 92780<br>U.S.A. |
| Contact: | Laraine Pangelina |
| Predicate Device: | MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891) |
| Device Description: | The Cosmos consist of an implant coil made of platinum alloy.<br>The coils are designed in 3D spherical structure in various loop<br>sizes and lengths. The coil is attached to a V-Trak™ MCS<br>delivery pusher via a polymer filament. The delivery pusher<br>contains radiopaque positioning markers at the distal end. The<br>proximal end is inserted into a hand held battery powered V-<br>Grip™ Detachment Controller. The implant segment detaches<br>upon activation of the Detachment Controller. |
| Indications for Use: | The Cosmos is a member of the MicroPlex Coil System (MCS).<br>The intended use as stated in the product labeling is as follows:<br>The MicroPlex Coil System is intended for the endovascular<br>embolization of intracranial aneurysms and other neurovascular<br>abnormalities such as arteriovenous malformations and<br>arteriovenous fistulae. The MCS is also intended for vascular<br>occlusion of blood vessels within the neurovascular system to<br>permanently obstruct blood flow to an aneurysm or other vascular<br>malformation and for arterial and venous embolizations in the<br>peripheral vasculature. |

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Bench

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| Test | Result |
|------------------------------|--------------------------|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Detachment Test | Met established criteria |
| Detachment Zone Tensile | Met established criteria |
| Advancement/Retraction Force | Met established criteria |
| Coil to Coupler Weld Tensile | Met established criteria |
| Spring Constant | Met established criteria |

## Summary of Substantial Equivalence:

The Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

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

MicroVention Terumo c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Ave. Tustin, CA 92780

## JAN 2 1 2010

Re: K093919

Trade/Device Name: MicroPlex Coil System - Cosmos, Models: 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, and 101245CSSR-V

Regulation Number: 21 CFR 882.5950

Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: December 21, 2009 Received: December 22, 2009

Dear Ms. Pangelina:

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 elass 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 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.

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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/CDRHOffices/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/cdrl/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

| 510(k) Number (if known): | K093919 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroPlex Coil System (MCS) - Cosmos |
| Indications for Use: | The MicroPlex Coil System is intended for the endovascular<br>embolization of intracranial aneurysms and other<br>neurovascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae. The MCS is also<br>intended for vascular occlusion of blood vessels within the<br>neurovascular system to permanently obstruct blood flow to an<br>aneurysm or other vascular malformation and for arterial and<br>venous embolizations in the peripheral vasculature. |

Prescription Use _ X (Per 21 CFR 801.109)

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AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

.

Jeffrey Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k093919