HYDROFRAME (HES)

K090357 · MicroVention, Inc. · HCG · Apr 10, 2009 · Neurology

Device Facts

• Record ID: K090357
• Device Name: HYDROFRAME (HES)
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Apr 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

HydroFrame consists of platinum alloy implant coil with inner hydrogel core; 3D spherical structure. Delivered via V-Trak MCS pusher; connected to hand-held battery-powered V-Grip Detachment Controller. Used in neurovascular/peripheral procedures by physicians. Controller triggers detachment of coil from pusher. Hydrogel core expands upon contact with blood to facilitate occlusion. Device provides permanent obstruction of blood flow to aneurysms or vascular malformations.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional measurement, simulated use, detachment testing, tensile testing, spring constant evaluation, and gel expansion verification. All tests met established criteria.

Technological Characteristics

Platinum alloy implant coil with hydrogel core; 3D spherical loop design. V-Trak MCS delivery pusher with radiopaque markers. V-Grip battery-powered detachment controller. 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 and venous embolization in the 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

• MicroVention, Bare Platinum Framing Coils (K082461)
• MicroVention, HydroSoft (HES) (K080666)

Submission Summary (Full Text)

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K090357 /P1/2

510(k) Summary

# APR ] 0 2009

| Trade Name: | HydroFrame - HydroCoil Embolic System (HES) | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device | | |
| Classification: | Class II, 21 CFR 882.5950 | | |
| Submitter Name<br>and Address | MicroVention, Inc<br>75 Columbia<br>Aliso Viejo, California U.S.A. | | |
| Contact Name: | Florin Truuvert<br>Senior Director, Worldwide Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | | |
| Predicate Device: | 510(k)<br>K082461<br>K080666 | Description<br>MicroVention, Bare Platinum Framing Coils<br>MicroVention, HydroSoft (HES) | Clearance Date<br>Oct 2, 2008<br>July 11, 2008 |

### Device Description

The HydroFrame coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop with miller hydroget core. he a V-Trak™ MCS delivery pusher via a polymer fillament. 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 proximal end is niscreed into nell onecry powered.
Costroller Controller.

#### Indication 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 artiovenous 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 various values va

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K090357

P.2/2

Verification and Test Summary Table

| Bench Testing | Result |
|------------------------------|--------------------------|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| 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 |
| Gel Expansion | Met established criteria |

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the HydroFrame coils when compared with the predicate device MicroVention Inc., Bare Platinum Framing Coils (K082461) and the HydroSoft coils (K08066).

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 HydroFrame coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic that resembles a bird in flight, composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. c/o Florin Truuvert Senior Director, Worldwide Regulatory Affairs 75 Columbia. Suite A Aliso Viejo, CA 92656

APR 1 0 2009

Re: K090357

Trade/Device Name: HydroFrame Hydrocoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulatory Class: Class II Product Code: HCG, KRD Dated: February 10, 2009 Received: February 12, 2009

Dear Ms. Truuvert:

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 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.

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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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

R. le. Mean, MD k

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

Enclosure

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K090357

## Indications for Use

510(k) Number (if known): K090357

HydroFrame Hydrocoil Embolic System (HES) Device Name:

Indications For Use:

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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

J.M.S.

(Division Si Division of Ophthalmic and Ear. Nose and Throat Devices

**510(k) Number** KC090357

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