MICROPLEX COIL SYSTEM- COSMOS

K102365 · MicroVention, Inc. · KRD · Nov 18, 2010 · Cardiovascular

Device Facts

• Record ID: K102365
• Device Name: MICROPLEX COIL SYSTEM- COSMOS
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• 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 18) is a neurovascular embolization device consisting of a 3D spherical platinum/tungsten alloy coil attached to a V-Trak delivery pusher via a polyolefin elastomer filament. Used in clinical settings by physicians for endovascular procedures. The device is delivered via microcatheter to the target site; detachment is triggered by a hand-held, battery-powered V-Grip Detachment Controller. Radiopaque markers on the pusher aid positioning. The coil permanently obstructs blood flow to aneurysms or vascular malformations. Benefits include effective embolization and occlusion of neurovascular and peripheral vascular abnormalities.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional measurement, simulated use (tracking, deployment, frame tumbling, microcatheter manipulation, basket formation, shape retention), detachment zone tensile strength, advancement/retraction force, coil-to-coupler weld tensile strength, and spring constant. All tests met the same specifications as the predicate device.

Technological Characteristics

Implant coil: Platinum/tungsten (92/8%) alloy. Coupler: Platinum/iridium (90/10%). Attachment: Polyolefin elastomer. Adhesive: Ultraviolet curing adhesive (DYMAX 1128-AM-VT). 3D spherical structure. MRI compatible. Sterile, single-use. Detachment via external battery-powered controller.

Indications for Use

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

Regulatory Classification

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.

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 § 870.1(e).

Predicate Devices

• MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K090891)

Submission Summary (Full Text)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 1 8 2010

| Trade Name: | MicroPlex Coil System - Cosmos 18 |
|-------------------|------------------------------------------------------------------------------|
| 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 U.S.A. |
| Contact: | Laraine Pangelina |
| Predicate Device: | MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K090891) |

1102368#### Device Description:

The Cosmos coils 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™ 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 (sold separately). The implant segment detaches upon activation of the Detachment Controller.

#### 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.

#### Bench Test Summary:

| Visual Inspection | Met same specifications as predicate |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Dimensional Measurement | Met same specifications as predicate |
| Simulated Use:<br>Introduction, Tracking, Deployment, Frame tumbling,<br>Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, .<br>Basket formation, Shape retention, Overall performance | Met same specifications as predicate |
| Detachment Zone Tensile | Met same specifications as predicate |
| Advancement/Retraction Force | Met same specifications as predicate |
| Coil to Coupler Weld Tensile | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate |

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| Feature | Predicate Device | 510(k) Subject Device |
|------------------------------|---------------------------------------------------------|-----------------------|
| Design Attributes | | |
| Coil Shape | 3D- spherical | Same |
| Coil OD | 6-13 mm | 14-24 mm |
| Coil Length | 17-47 cm | 51-68 cm |
| Pusher length | 185 cm | Same |
| Materials | | |
| Main Coil Wire | Platinum/Tungsten (92/8%) alloy | Same |
| Coil to Pusher Coupler | Platinum (90%)/ iridium (10%) | Same |
| Adhesive | Ultraviolet curing adhesive<br>(DYMAX 1128-AM-VT) | Same |
| Implant to Pusher Attachment | Polyolefin elastomer | Same |
| General | | |
| MRI compatibility | Yes | Same |
| Method of Supply | Sterile, single use | Same |
| Package Configuration | Placed in dispenser coil, pouch, and<br>shipping carton | Same |

Technological comparison, subject and predicate device:

## Summary of Substantial Equivalence:

The MCS 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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### 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 features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

MicroVention, Inc. c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

1 8 2010 NOV

K102365 Re:

Trade/Device Name: MicroPlex Coil System - Cosmos 18 Regulation Number: 21 CFR 870.3300

·Regulation Name: Vascular-Embolization-Device Regulatory Class: Class II Product Code: KRD, HCG Dated: August 19, 2010 Received: August 20, 2010

### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Laraine Pangelina

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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

inna R. Vachner

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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## INDICATIONS FOR USE

| 510(k) Number (if known): | K102365 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 18 2010 |
| 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 (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)

Dune R. Vuchner
Division Sign-On

(Division Sign-Off) . Division of Cardiovascular Devices

510(k) Number_K102 36 رَدَهُ وَ