MICROPLEX COIL SYSTEM-COSMOS

K090891 · MicroVention, Inc. · HCG · Jun 22, 2009 · Neurology

Device Facts

• Record ID: K090891
• Device Name: MICROPLEX COIL SYSTEM-COSMOS
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 22, 2009
• Decision: SESE
• Submission Type: Traditional
• 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

Cosmos is a platinum alloy implant coil with 3D spherical structure; used for endovascular embolization of intracranial aneurysms and neurovascular abnormalities. Coil attaches to V-Tracker MCS delivery pusher via polymer filament; pusher features radiopaque markers for positioning. Proximal end connects to handheld, battery-powered V-Grip 10 Detachment Controller; activation triggers coil detachment. Used by physicians in clinical settings. Device provides permanent blood flow obstruction to aneurysms or vascular malformations, benefiting patients by reducing risk of rupture or hemorrhage.

Clinical Evidence

Bench testing only. Testing 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 verification. All tests met established criteria.

Technological Characteristics

Platinum alloy implant coil; 3D spherical structure. Delivery system includes V-Tracker pusher with radiopaque markers and V-Grip 10 battery-powered detachment controller. Polymer filament attachment. No software or electronic algorithms involved in device function.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels; and arterial and 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 - Bare Platinum Framing Coil (K082461)

Submission Summary (Full Text)

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# K09089

# 510(k) Summary

JUN 2222009

| Trade Name: | MicroPlex Coil System – Cosmos |
|-----------------|--------------------------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc<br>75 Columbia<br>Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |

# Predicate Device:

な

| Number | Description | Clearance Date |
|---------|-------------------------------------------------------|-----------------|
| K082461 | MicroPlex Coil System - Bare Platinum<br>Framing Coil | October 2, 2008 |

## Device Description

The Cosmos consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Traker MCS delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip 10 Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

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#### Indication For Use

The Cosmos is a member of the MicroPlex Coil System (MCS). The intended use as stated in the product labeling is as follows:

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.

#### Verification and Test Summary Table

| Bench Testing | 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 data presented in this submission demonstrates the technological similarity and equivalency of the Cosmos coils when compared with the predicate device MicroVention MicroPlex Bare Platinum Framing Coils (K082461).

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 Cosmos coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 22 2009

. Ja

Re: K090891

Trade Name: MicroPlex Coil System (MCS) - Cosmos Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: May 15, 2009 Received: May 18, 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.

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/cdrh/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 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):_ K090891

Device Name: MicroPlex Coil System (MCS) - Cosmos

Indications For 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.

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)

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

K09089

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