MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)

K032590 · MicroVention, Inc. · HCG · Oct 22, 2003 · Neurology

Device Facts

• Record ID: K032590
• Device Name: MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are 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

Implantable embolic coils delivered via fluid injection system; pusher consists of variable stiffness stainless steel tube with PET tubing layers. System includes luer hub for de-airing and coil detachment; coupler attaches coil to pusher. Delivered through standard neuro-interventional micro-catheters; introducer sheath assists placement. Syringes (1.0-cc for de-airing, 0.25-cc for detachment) used during procedure. Used by clinicians in neuro-interventional settings to permanently obstruct blood flow to aneurysms or vascular malformations. Benefits include minimally invasive treatment of neurovascular abnormalities.

Clinical Evidence

No clinical data. Performance evidence based on bench testing (tensile strength, coil detachment, simulated use) and animal testing referenced from previous submissions (K012145, K021914, K020434).

Technological Characteristics

Materials: stainless steel, PET tubing. Delivery: fluid injection system with variable stiffness pusher. Connectivity: none. Sterilization: not specified. Software: none.

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 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 (K020434)
• MicroCoil System (K031578)

Submission Summary (Full Text)

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OCT 2 2 2003

K032590
P/2

# Section 2 - Summary of Safety and Effectiveness

### Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: [phone] Fax: [phone] www.microvention.com

#### Contact Information (2)

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

#### Device Name (3)

| Classification Name: | Device, Artificial Embolization |
|-------------------------|-----------------------------------------------------------------|
| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS)<br>HydroCoil® Embolic System (HES) |
| Common/Usual Name: | Embolization Coil |

#### Device Description (4)

The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

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K032590
P2/2

#### (5) Indications for Use

The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The MCS and HES are 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.

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

The MicroVention MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are substantially equivalent to the MicroPlex™ Coil System that was determined to be substantially equivalent on July 29, 2002 (reference K020434) and the MicroCoil System that was determined to be substantially equivalent on August 1, 2003 (reference K031578).

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

The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are 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 documented in K012145, K021914 and K020434, including tensile strength, coil detachment, simulated use and animal testing, has demonstrated that the MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are equivalent in performance to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vincent Cutarelli Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656

Re: K032590

Trade/Device Name: MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 19, 2003 Received: August 22, 2003

Dear Mr. Cutarelli:

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 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 (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.

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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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Mark N Millkan

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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K 032590

## Indications For Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES)

Indications for Use: The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The MCS and HES are 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.

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

for Mark N. Melkner

vision Sign-Off) Division of General, Restorative nd Neurological Devices

Prescription Use: __ X_ (Per 21 CFR 801.109)