HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

K091641 · MicroVention, Inc. · HCG · Jun 30, 2009 · Neurology

Device Facts

• Record ID: K091641
• Device Name: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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

HydroSoft and HyperSoft coils are neurovascular embolization implants; helical platinum alloy coils; HydroSoft includes inner hydrogel core. Coils attach to V-Trak delivery pusher via polymer filament; pusher features radiopaque markers for positioning. Physician operates device under fluoroscopic guidance; proximal end of pusher inserts into hand-held, battery-powered V-Grip Detachment Controller. Activation of controller triggers detachment of implant segment from pusher. Used in neurovascular and peripheral vascular procedures to permanently obstruct blood flow to aneurysms or malformations.

Clinical Evidence

Bench testing only. Testing included simulated use, detachment testing, detachment zone tensile testing, advancement/retraction force, coil-to-coupler weld tensile testing, and spring constant verification. All tests met established criteria.

Technological Characteristics

Platinum alloy helical coils; HydroSoft includes hydrogel core. Delivery via polymer filament to V-Trak pusher. Radiopaque markers for visualization. Battery-powered V-Grip Detachment Controller for electrical detachment. Sterilized using standard processes.

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

• HydroCoil Embolic System with the HES-HC-HS (10) (K070656)
• MicroPlex Coil System and HydroCoil Embolic System (K0509054)

Submission Summary (Full Text)

{0}------------------------------------------------

091641

# JUN 3 0 2009

## 510(k) Summary

| Trade Name: | HydroCoil Embolic System - HydroSoft<br>MicroPlex Coil System - HyperSoft |
|-----------------|---------------------------------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc<br>75 Columbia<br>Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |

#### Predicate Devices:

| Number | Description | Clearance Date |
|----------|--------------------------------------------------------------------------------------------|----------------|
| K070656 | HydroCoil Embolic System with the<br>HES-HC-HS (10) [marketed under the<br>HydroSoft name] | June 15, 2007 |
| K0509054 | MicroPlex Coil System and HydroCoil<br>Embolic System | June 28, 2005 |

## Device Description

The HydroSoft coils consist of an implant made of plantinum alloy with an inner hydrogel core. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-TrakTM delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip " Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

The HyperSoft coils consist of an implant coil made of platinum alloy. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

{1}------------------------------------------------

### Indications For Use

The HydroSoft and HyperSoft coils are members of the HydroCoil Embolic System (HES) and MicroPlex Coil System (MCS). The intended use as stated in the product . labeling is as follows:

The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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.

| Bench Testing | Result |
|------------------------------|--------------------------|
| Simulated Use | Met established criteria |
| Detachment Test | Met established criteria |
| Detachment Zone Tensile | Met established criteria |
| Advancement/Retraction Force | Met established criteria |
| Coil to Coupler Weld Tensile | Met established criteria |
| Spring Constant | Met established criteria |

## Verification and Test Summary Table

## Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the HydroSoft and HyperSoft coils when compared with the predicate devices (K070656 and K050954)

The devices,

- . Have the same intended use,
- Use the same operating principle, �
- . Incorporate the same basic design,
- . Use similar construction and material,
- . Are packaged and sterilized using same material and processes.

In summary, the HydroSoft and HyperSoft coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

{2}------------------------------------------------

### 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 features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

JUN 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager 75 Columbia Suite A Aliso Viejo, CA 92656

Re: K091641

Trade/Device Name: MicroVention HydroCoil® Embolic System (HES) - HydroSoft Coils and MicroPlex® Coil System (MCS) - HyperSoft Coils

Regulation Number: 21 CFR 882.5950

Regulation Name: Neurovascular Embolization Device

Regulatory Class: II Product Code: HCG Dated: June 3, 2009 Received: June 4, 2009

Dear Ms. Gong:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

K09164

510(k) Number (if known):

Device Name:

HydroSoft Embolic System (HES) - HydroSoft Coils MicroPlex Coil System (MCS) - HyperSoft Coils

Indications For Use:

The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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.

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

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)

Jeff Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091641

Page 1 of 1