HYDROCOIL EMBOLIC SYSTEM (HES)

K120908 · MicroVention, Inc. · HCG · Apr 25, 2012 · Neurology

Device Facts

• Record ID: K120908
• Device Name: HYDROCOIL EMBOLIC SYSTEM (HES)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Apr 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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) is a neurovascular embolization device; consists of platinum/tungsten alloy helical coil with hydrophilic copolymer hydrogel core; attached to V-Trak delivery pusher. Operated by physician in clinical setting; proximal end of pusher inserted into hand-held, battery-powered V-Grip Detachment Controller; activation of controller detaches implant segment. Device used for permanent obstruction of blood flow in intracranial aneurysms, vascular malformations, and peripheral vasculature. Provides mechanical occlusion and hydrogel-mediated expansion to fill space; benefits patient by reducing blood flow to pathological vascular structures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through comparative bench testing against predicate device, including simulated use, mechanical integrity (weld tensile, spring constant), and functional characteristics (gel expansion, advancement/retraction force).

Technological Characteristics

Implantable helical coil; platinum/tungsten alloy (92/8%) main wire; platinum/iridium (90/10%) coupler; hydrophilic copolymer hydrogel core; PET stretch-resistant filar; polyolefin elastomer implant-to-pusher interface. Dimensions: 2-24 mm diameter, 2-50 cm length. Delivery: V-Trak pusher with V-Grip battery-powered detachment controller. Sterile, single-use. MRI compatible.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels to obstruct blood flow to aneurysms or vascular malformations; and arterial/venous embolization 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 (K112226, K113457)

Submission Summary (Full Text)

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# K120908

APR 2 5 2012

#### MicroVention. Inc. Special 510(k) HydroCoil Embolic System (HES) -- Modification to HydroFill (formerly HydroSoft Plus)

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

HydroCoil Embolic System (HES) Trade Name: Neurovascular Embolization Device, accessory Generic Name: Class II, 21 CFR 882.5950 Classification: MicroVention, Inc Submitted By: 1311 Valencia Avenue Tustin, California 92780 U.S.A. Laraine Pangelina Contact: HydroCoil Embolic System (HES) (K112226, K113457) Predicate Device: Indications for Use: The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula. 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 embolization in the peripheral vasculature. The HES consists of implantable coil made of platinum alloy with inner Device Description: hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The modified HES is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

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## MicroVention, Inc.

Special 510(k)

Special Jro(K)
HydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)

| | Bench Test Summary: |
|--|---------------------|
|--|---------------------|

| Test | Result |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use<br>• Introduction<br>• Tracking<br>• Reposition / Deployment<br>• Detachment<br>• Overall Performance | Met same criteria as predicate |
| Spring Constant | Met same criteria as predicate |
| Gel Expansion | Met same criteria as predicate |
| Weld Tensile | Met same criteria as predicate |
| Advancement / Retraction Force | Met same criteria as predicate |

## Predicate / Subject Device Comparison:

| Feature | Predicate Device | Subject Device |
|-------------------------------------|-------------------------------------|----------------|
| Coil shape | Helical | Same |
| Implant diameter | 2 mm - 24 mm | Same |
| Implant restrained length | 2 cm - 50 cm | Same |
| Deliver pusher length | 185 cm | Same |
| Main coil wire material | Platinum/Tungsten<br>(92/8 %) alloy | Same |
| Coupler material | Platinum (90%) /<br>iridium (10%) | Same |
| Adhesive material | Dymax 1128-AM-<br>VT | Same |
| Implant to pusher material | Polyolefin<br>Elastomer | Same |
| Stretch resistant filar<br>material | Polyolefin<br>Elastomer | PET |
| Gel material | Hydrophilic<br>Copolymer | Same |
| MRI compatibility | Yes | Yes |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser, pouch,<br>carton | Same |

## Summary of Substantial Equivalence:

The HES coils that are the subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient equivalent to the productions as terrals, processes, and operating principal.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol, possibly an eagle, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 2 5 2012

MicroVention c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K120908

Trade/Device Name: HydroCoil Embolic System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 23, 2012 Received: March 26, 2012

Dear Ms. Pangelina:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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## Page 2 - Ms. Laraine Pangelina

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 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.

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/CDRH/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Image /page/3/Picture/8 description: The image shows a stylized signature in black ink. The signature appears to be a cursive "f" connected to another letter, possibly an "r" or a similar character. The overall impression is that of a quick, flowing signature.

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

Enclosure

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#### MicroVention, Inc. Special 510(k) BydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)

### INDICATIONS FOR USE

K120908

510(k) Number (if known):

Device Name:

Indications for Use:

HydroCoil Embolic System (HES)

The 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.

Prescription Use X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jeffrey Toy

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

510(k) Number k120908