MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX

K111451 · MicroVention, Inc. · HCG · Sep 20, 2011 · Neurology

Device Facts

• Record ID: K111451
• Device Name: MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Sep 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula. 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 embolization in the peripheral vasculature.

Device Story

MicroPlex Coil System (MCS) Vector is an implantable neurovascular embolization device. System comprises bare platinum/tungsten alloy 3D coils attached to V-Trak delivery pushers. Operated by physicians in clinical settings; proximal end of pusher connects to hand-held, battery-powered V-Grip Detachment Controller. Upon activation, coil detaches from pusher to occlude blood flow in aneurysms or vascular malformations. Device provides permanent obstruction of blood flow; MRI compatible. Benefits include minimally invasive treatment of intracranial aneurysms and other neurovascular abnormalities.

Clinical Evidence

Bench testing only. Testing included dimensional measurements, simulated use (introduction, tracking, deployment, detachment), spring constant, and tensile strength (weld and detachment zone). All results met the same criteria as the predicate devices.

Technological Characteristics

Implantable 3D coil made of platinum/tungsten alloy. Coupler: platinum/iridium. Adhesive: ultraviolet cure. Stretch-resistant filar and implant-to-pusher material: polyolefin elastomer. Delivery pusher length: 185cm. MRI compatible. Sterile, single-use. Detachment via battery-powered electrical controller.

Indications for Use

Indicated for patients requiring endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and vascular occlusion of blood vessels within the neurovascular system or 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 - Cosmos 10 (K082461, K093919, K103758)
• MicroPlex Coil System - Cosmos 18 (K090891, K093358)

Submission Summary (Full Text)

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K///451

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Trade Name: | MicroPlex Coil System - Vector | SEP 2 0 2011 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|--------------|
| Generic Name: | Neurovascular Embolization Device | |
| 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 - Cosmos 10 (K082461, K093919, K103758)<br>MicroPlex Coil System - Cosmos 18 (K090891, K093358) | |

## Device Description:

The MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. 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.

The table below provides information about the physical properties of the MCS Vector with a comparison to the predicate devices.

| Feature | MCS - Cosmos 10 | MCS - Cosmos 18 | MCS - Vector |
|-------------------------------------|----------------------------------------------|-----------------|--------------|
| Coil shape | 3D | Same | Same |
| Coil implant diameter | 2-12mm | 6-24mm | 3-15mm |
| Coil restrained length | 2-45cm | 17-68cm | 6-60cm |
| Deliver pusher length | 185cm | Same | Same |
| Main coil wire material | Platinum/Tungsten<br>alloy | Same | Same |
| Coupler material | Platinum/Iridium | Same | Same |
| Adhesive material | Utraviolet cure | Same | Same |
| Implant to pusher material | Polyolefin elastomer | Same | Same |
| Stretch resistant filar<br>material | Polyolefin elastomer | Same | Same |
| MRI compatibility | Yes | Yes | Yes |
| Method of supply | Sterile, single use | Same | Same |
| Packaging configuration | Dispenser coil;<br>pouch, shipping<br>carton | Same | Same |

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្រុក

| Indications for Use: | Intended for the endovascular embolization of intracranial<br>aneurysms and other neurovascular abnormalities such as<br>arteriovenous malformations and artiovenous fistula. The MCS<br>is also intended for vascular occlusion of blood vessels within<br>the neurovascular system to permanently obstruct blood flow to<br>an aneurysm or other vascular malformation and for arterial and<br>venous embolization in the peripheral vasculature. | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Bench Test Summary: | Test | Result |
| | Dimensional Measurement | Met same criteria as predicate |
| | Simulated Use:<br>Introduction, Tracking,<br>Deployment, Frame movement,<br>Microcatheter movement,<br>Microcatheter manipulation,<br>Compartmentalization,<br>Detachment, Overall performance | Met same criteria as predicate |
| | Spring Constant | Met same criteria as predicate |
| | Weld Tensile Strength | Met same criteria as predicate |
| | Detachment Zone Tensile Strength | Met same criteria as predicate |

.

.

Summary of Substantial Equivalence:

The MCS Vector is substantially equivalent to the predicate devices with regard to intended use, patient population, device design, materials, processes, and operating principal.

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11:00:22 Ad: 0 10963 New Hampsince Acenne Documents online Room Welodsono Silver Spring, MD 20003-0000

Microvention, Inc. c/o Ms. Laraine Pangelina 1311 Valencia Ave Tustin. CA 92780

SEP 2 0 2011

Re: K111451

Trade/Device Name: Microplex Coil System-Vector Regulation Number: 21 CFR 882.5950 Regulation Name: Device. Neurovascular embolization Regulatory Class: Class II Product Code: HCG Dated: August 9, 2011 Received: August 10. 2011

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. Ilisting 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.

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 -

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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 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html 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.lda.gov/MedicalDevices/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eaton m. f.

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):

Device Name:

Indications for Use:

KIII45|

MicroPlex Coil System - Vector

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)

Jeffrey Toy

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

510(k) Number K111451