HYDROCOIL EMBOLIC SYSTEMS (HES)

K071939 · MicroVention, Inc. · KRD · Jan 11, 2008 · Cardiovascular

Device Facts

• Record ID: K071939
• Device Name: HYDROCOIL EMBOLIC SYSTEMS (HES)
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.

Device Story

HydroCoil Embolic System (HES) consists of implantable embolic coil housed in introducer; stainless steel stylet used for deployment. Device delivered to peripheral vasculature treatment site via delivery catheter using standard guidewire (not included). Used by interventional radiologists to reduce/block blood flow in vessels; treats arteriovenous malformations, fistulae, aneurysms, and other peripheral lesions. Provides mechanical occlusion of target vessels; benefits patient by managing vascular lesions through minimally invasive endovascular approach.

Clinical Evidence

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

Technological Characteristics

Implantable embolic coil system; stainless steel stylet; introducer-based delivery; peripheral vasculature application; Class II device (Product Code KRD).

Indications for Use

Indicated for interventional radiologic management of peripheral vasculature lesions including arteriovenous malformations, arteriovenous fistulae, and aneurysms in patients requiring blood flow reduction or occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

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 § 870.1(e).

Predicate Devices

• Cordis Vascular Occlusion System (K983483)
• MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with a Modified Detachment System (K050954)
• MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (18) Coils (K032590)

Submission Summary (Full Text)

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K071939

# Section 2 - 510(k) Summary

### (1) Company Information

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

## (2) Contact Information

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

#### (3) Device Name

| Classification Name: | Device, Embolization, Arterial |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | HydroCoil ^® Embolic System (HES) |
| | AZUR ^TM Peripheral HydroCoil ^® Endovascular Embolization Coil System - Pushable 18 and 35 |
| Common/Usual Name: | Embolization Coil |
| Classification | Class II |

#### (4) Device Description

.

The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. Both the delivery catheter and guidewire are not included in the system.

JAN
1 2000

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## (5) Indications for Use

The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.

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

The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent to the Cordis Vascular Occlusion System that was determined to be substantially equivalent on March 24, 1999 (reference K983483), the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a Modified Detachment System that was determined to be substantially equivalent on June 28, 2005 (reference K050954) and the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (18) Coils that was determined to be substantially equivalent on October 22, 2003 (reference K032590)..

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

The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices.

#### (8) Performance Data Summary

Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is equivalent in performance to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

JAN 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention Inc. c/o Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance 75 Columbia, Suite A Aliso Viejo, CA 92656

Re: K071939

HydroCoil® Embolization System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 30, 2007 Received: November 2, 2007

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.

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Page 2 - Mr. Vincent Cutarelli

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Duna R. Vuchner

( ) Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(k) Number: __K071939

Device Name: HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils

Indications for Use: The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.

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

Duana R. Lechner
(Division Sign-Off)
Division of Cardiac

(1978) Sign-Oli)
Division of Cardiovascular Devices

510(k) Number_k © 7 193 9

Prescription Use: __X (Per 21 CFR 801.109)