MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT

K022735 · MicroVention, Inc. · HCG · Sep 6, 2002 · Neurology

Device Facts

• Record ID: K022735
• Device Name: MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit are 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 and HES are 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 coils (complex/helical) and hydrophilic polymer-coated coils; delivered via fluid injection delivery system (Delivery Pusher) through standard neurointerventional microcatheters. HydroLink Syringe Kit used for system de-airing and coil detachment. Used by neurosurgical teams in clinical settings for embolization of intracranial aneurysms, AVMs, AV fistulae, and peripheral vasculature. Physician operates delivery system to place coils, creating framework or filling space to occlude vascular abnormalities. Benefits include minimally invasive alternative to traditional operative techniques for high-risk or inoperable patients.

Clinical Evidence

Bench testing only. Performance testing included tensile strength, coil detachment, and simulated use. Results demonstrated equivalent performance to predicate devices.

Technological Characteristics

Implantable platinum coils; some models include hydrophilic acrylic polymer coating. Delivery system consists of variable stiffness tube with retention sleeve. Includes syringes for de-airing and detachment. Manual operation; no software or electronic components.

Indications for Use

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

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

• MicroVention MicroPlex Coil System (MCS) (K012145)
• MicroVention MicroPlex Coil System (MCS) (K021914)
• MicroVention MicroPlex Coil System (MCS) (K020434)
• Merit Medical Piston Syringe (K875196)

Submission Summary (Full Text)

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K022735

# 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

#### (2) Contact Information

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

#### (3) Device Name

| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS) and<br>HydroCoil™ Embolic System (HES) with the<br>HydroLink™ Syringe Kit |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Embolization Coil |
| Classification Name: | Device, Artificial Embolization |

#### (4) Device Description

The MicroVention 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 coil is delivered on the Delivery Pusher through standard neurointerventional microcatheters. 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 coil into the microcatheter. The HydroLink Syringe Kit is packaged separately and includes a 1.0-cc syringe for system de-airing and a 0.25-cc and/or 0.5-cc syringe for coil detachment. An introducer needle is also included for use with the 0.25-cc or 0.5-cc syringe to fill the hub of the Delivery Pusher with contrast agent and eliminate any air.

The MicroPlex Coil System (MCS) is marketed in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that are used

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K022735

to establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide additional filling once the initial framework has been established by one or more complex coils. The MCS-CC-2D, MCS-CC-1D, MCS-HC-R and MCS-HC-S platinum coils were determined to be substantially equivalent on October 29, 2001 (reference K012145). The MCS-HC-SX platinum coils were determined to be substantially equivalent on July 9, 2002 (reference K021914). The complex and helical coils are provided in a number of diameters and lengths to meet the needs of the physician.

The MCS-HCP are platinum helical coils 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 platinum complex coils. The MCS-HCP coils were determined to be substantially equivalent on July 29, 2002 (reference K020434) and were originally included as part of the MicroPlex Coil System (MCS). In order to differentiate the platinum/polymer coils from the platinum coils, the system trade name has been changed to HydroCoil Embolic System (HES) and the coils are denoted as HES-HC-R.

#### (5) Indications for Use

The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit are 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 and HES are 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.

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

MicroVention MicroPlex Coil System (MCS) - K012145 (October 29, 2001) MicroVention MicroPlex Coil System (MCS) - K021914 (July 9, 2002) MicroVention MicroPlex Coil System (MCS) - K020434 (July 29, 2002) Merit Medical Piston Syringe - K875196 (February 11, 1988)

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

The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit is substantially equivalent to the MicroPlex Coil System (MCS) that was determined to be substantially equivalent per K012145, K021914 and K020434 and the Merit Medical Piston Syringe that was determined to be substantially equivalent per K875196. The operating principles, method of application, indications for use and technological characteristics are the same as the predicate devices.

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#### (8) Performance Data Summary

Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit has equivalent performance to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

#### 6 2002 SEP

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, CA 92656

Re: K022735

Trade/Device Name: MicroPlex™ Coil System (MCS) and HydroCoil™ Embolic System with the HydroLink™ Syringe Kit.

Regulation Number: 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 14, 2002 Received: August 19, 2002

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 (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 vours.

Stupt Riwola

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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K022735

## Indications For Use

510(k) Number:

Device Name: MicroPlex™ Coil System (MCS) and HydroCoil™ Embolic System with the HydroLink™ Syringe Kit

Indications for Use: The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit are 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 and HES are 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):

Stupt Roody

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO22735 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use: _ X_ (Per 21 CFR 801.109)