MICROPLEX COIL SYSTEM (MCS)

K020434 · MicroVention, Inc. · HCG · Jul 29, 2002 · Neurology

Device Facts

• Record ID: K020434
• Device Name: MICROPLEX COIL SYSTEM (MCS)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

Device Story

Implantable platinum embolization coil system; includes delivery pusher with retention sleeve and peel-away introducer sheath. Used by neurosurgical teams in clinical settings for endovascular treatment. Complex coils (MCS-CC) establish initial aneurysm framework; helical coils (MCS-HC) and hydrophilic polymer-coated helical coils (MCS-HCP) provide additional filling. Delivered via microcatheter to target site. Provides mechanical occlusion of vascular abnormalities; benefits patients by offering minimally invasive alternative to traditional open surgery for high-risk or inoperable lesions.

Clinical Evidence

Bench testing including tensile strength, coil detachment, and simulated use; biocompatibility testing; animal testing. No human clinical trial data provided.

Technological Characteristics

Platinum complex and helical coils; MCS-HCP includes hydrophilic acrylic polymer coating. Delivery system uses variable stiffness tube with retention sleeve. Compatible with 10-, 14-, and 18-type microcatheters. Sterilized device.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable via traditional surgery, and for patients with neuro-vascular abnormalities (arteriovenous malformations, arteriovenous fistulae) or peripheral vascular conditions requiring embolization.

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

• Guglielmi Detachable Coil (GDC) (K993417)
• MicroPlex Coil System (MCS) (K012145)
• Matrix Detachable Coil System (K012985)

Submission Summary (Full Text)

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# Section 2 - Summary of Safety and Effectiveness

### Company Information (1)

MicroVention, Inc. 72 Argonaut Aliso Viejo, CA 92656 Telephone: [phone] Fax: [phone] www.microvent.com

#### Contact Information (2)

Vincent Cutarelli Telephone: [phone] ext. 105 Fax: [phone] E-mail: [e-mail]

#### (3) Device Name

| Classification Name: | Device, Artificial Embolization |
|-------------------------|---------------------------------|
| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS) |
| Common/Usual Name: | Embolization Coil |

#### (4) Device Description

The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the implantable coil into the microcatheter.

The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS-CC complex coils.

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The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.

### Indications for Use (5)

The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

#### Name of Predicate or Legally Marketed Device (0)

The MicroPlex Coil System (MCS) with the expanded indications for use and the additional model numbers is substantially equivalent to the Guglielmi Detachable Coil (GDC) that was determined to be substantially equivalent on January 21, 2000 (reference K993417), the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29, 2001 (reference K012145) and the Matrix Detachable Coil System that was determined to be substantially equivalent on February 1, 2001 (reference K012985).

#### (7) Technological Characteristics and Substantial Equivalence

The MicroPlex Coil System (MCS) is substantially equivalent in operating principle, method of application, indications for use, design, packaging and sterilization to the predicate devices.

## Performance Data Summary

(8)

Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices.

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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

MicroVention, Inc. Vincent Cutarelli 72 Argonaut Aliso Viejo, California 92656

Re: K020434

Trade Name: MicroPlex™ Coil System (MCS) Regulation Number: 887.5950 Regulation Name: Artificial Embolization Device : 2002 Regulatory Class: III Product Code: HCG Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Cutarelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 such 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); 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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## Page 2 - Mr. Vincent Cutarelli

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

for Mark N. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: MicroPlex™ Coil System (MCS)

Indications for Use: The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

Concurrence of CDRH, Office of Device Evaluation (ODE):

for Mark N. Milkersen

Division Sign-Off) Division of General. Restorative and Neurological Devic

510(k) Number K020434

Prescription Use: X (Per 21 CFR 801.109)