MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V

K093358 · MicroVention, Inc. · HCG · Jan 15, 2010 · Neurology

Device Facts

• Record ID: K093358
• Device Name: MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jan 15, 2010
• 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.

Device Story

MicroPlex Coil System (MCS) - Cosmos consists of platinum alloy implant coils with 3D spherical structures. Coils attach to V-Trak delivery pusher via polymer filament; pusher features distal radiopaque markers. System includes hand-held, battery-powered V-Grip Detachment Controller. Physician inserts proximal end of pusher into controller; activation triggers detachment of implant segment. Used in neurovascular procedures to embolize aneurysms or occlude vessels. Provides permanent obstruction of blood flow to vascular malformations.

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 coils; 3D spherical structure. V-Trak delivery pusher with polymer filament attachment and radiopaque markers. V-Grip battery-powered detachment controller. Mechanical detachment mechanism.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae, and for vascular occlusion of neurovascular blood vessels to permanently obstruct blood flow.

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 (K090891)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

ي

K093358
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Trade Name: MicroPlex Coil System - Cosmos

Generic Name: Neurovascular Embolization Device, accessory

Classification: Class II, 21 CFR 882.5950 JAN 1 5 2010

Submitted By: MicroVention, Inc
1311 Valencia Avenue
Tustin, California 92780
U.S.A.

Contact: Laraine Pangelina

Predicate Device: MicroPlex Coil System (MCS) - Cosmos (K090891)

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-Trak™ 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™ Detachment Controller. The implant segment detaches
upon activation of the Detachment Controller.

Indications 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.

{1}------------------------------------------------

## Bench Test Summary:

i

-

| 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

{2}------------------------------------------------

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

Laraine Pangelina Regulatory Affairs Project Manager MicroVention, Inc. 1311 Valencia Ave. Tustin, CA 92780

JAN 1 6 2010

Re: K093358

Trade/Device Name: MicroPlex Coil System (MCS) - Cosmos 18 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: October 27, 2009 Received: October 28, 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your devices of the result offices/ucm115809.htm for a go to http://www.lua.gov/About/Drb Centers (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) colust retification" (21CFR the Center for Devices and Radiological Hound of Concernation of (21CFR Party of the MDP requirition (2) note the regulation entitled, "Misolanding by recents under the MDR regulation (21
807.97). For questions regarding the reporting of adverse events office of 807.97). For questions regarding the open and of 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 You may 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,

Kesia Alexander Jr

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

{4}------------------------------------------------

#### INDICATIONS FOR USE

| 510(k) Number (if known): | K093358 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |

Prescription Use _X (Per 21 CFR 801.109) 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)

Kristen Bowsher

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

510(k) Number_k 09 3358