MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)

K041551 · MicroVention, Inc. · HCG · Jul 7, 2004 · Neurology

Device Facts

• Record ID: K041551
• Device Name: MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

HydroCoil Embolic System (HES) consists of platinum helical coil coated with hydrophilic polymer (cross-linked copolymer of acrylamide and acrylic acid) attached to stainless steel delivery pusher. Device used by neurointerventionalists in clinical settings to treat intracranial aneurysms and vascular malformations. Coil delivered via standard neurointerventional micro-catheters; system de-aired and coil detached using syringes. Hydrophilic coating expands upon contact with blood to facilitate occlusion. Permanent obstruction of blood flow to target site achieved; reduces risk of aneurysm rupture or malformation perfusion. System includes introducer sheath for catheter placement.

Clinical Evidence

No clinical data. Performance testing demonstrated equivalence to predicate devices.

Technological Characteristics

Platinum helical coils with hydrophilic polymer coating (cross-linked copolymer of acrylamide and acrylic acid). Delivery system: stainless steel tube with PET tubing layers. Luer hub for de-airing/detachment. Delivered via standard micro-catheters.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels to obstruct flow to aneurysms or malformations; 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

• HydroCoil® Embolic System (HES) (K032590)
• HydroCoil® Embolic System (HES) (K033836)
• Matrix™ Stretch Resistant Detachable Coils (K031168)

Submission Summary (Full Text)

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JUL = 7 2004

K041551

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# 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: | HydroCoil® Embolic System (HES) |
| Common/Usual Name: | Embolization Coil |

### (4) Device Description

The HydroCoil® Embolic System (HES) consists 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 HES coils are platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the 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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# Indications for Use (ર)

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

The HES 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.

# Name of Predicate or Legally Marketed Device (6)

The modified HydroCoil® Embolic System (HES) is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590) and December 30, 2003 (reference K033836), and to the Matrix™ Stretch Resistant Detachable Coils that were determined to be substantially equivalent on May 14, 2003 (reference K031168).

# Technological Characteristics and Substantial Equivalence (7)

The modified HydroCoil® Embolic System (HES) is equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices.

#### Performance Data Summary (8)

Performance testing has demonstrated that the modified HydroCoil® Embolic System (HES) is equivalent in performance to the predicate devices.

Koultt

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes.

JUL - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vincent Cutarelli Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs MicroVention, Inc. 75 Columbia, Suite A Aliso Viejo, California 92656

Re: K041551

Trade/Device Name: HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Embolization coil Regulatory Class: III Product Code: HCG Dated: June 7, 2004 Received: June 9, 2004

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 for association 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), 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 yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D.
Director 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 (if known):

Device Name: HydroCoit® Embolic System (HES)

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

The HES is also intended for vascular occlusion of blood vessels within the neurovascular THE ITED is and intelling to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

X = AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

**510(k) Number** K041851