FX DETACHABLE COIL SYSTEM

K060747 · Micro Therapeutics, Inc. · HCG · Apr 24, 2007 · Neurology

Device Facts

• Record ID: K060747
• Device Name: FX DETACHABLE COIL SYSTEM
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Story

FX Detachable Coil System consists of platinum embolization coil attached to composite implant delivery pusher; includes radiopaque positioning marker; utilizes handheld mechanical FX detachment actuator for coil release. Nexus version includes absorbable polymer microfilaments. Device used in clinical neurovascular procedures; operated by physicians. Actuator facilitates mechanical detachment of coil from pusher tip. Embolization of aneurysms/malformations/fistulae achieved via endovascular placement. Benefits include occlusion of neurovascular abnormalities to prevent rupture or reduce blood flow.

Clinical Evidence

Bench testing only. Testing included dimensional/visual analysis, force transfer, frictional characteristics, fatigue/reliability, tensile strength, particulate generation, distal tip buckling/stiffness, packaging integrity, and detachment actuator life cycle/reliability. All tests met established criteria.

Technological Characteristics

Platinum embolization coil; composite implant delivery pusher; radiopaque positioning marker; handheld mechanical detachment actuator. Nexus version includes absorbable polymer microfilaments. Sterilized using established processes.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae in patients requiring neurovascular embolization.

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

• Sapphire NXT Detachable Coil System (K041649)
• Nexus Detachable Coil System (K050543)
• Nexus Detachable Coil System (K051425)
• Nexus Detachable Coil System (K051560)

Submission Summary (Full Text)

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| Trade Name: | FX Detachable Coil System | |
|-----------------|---------------------------------------------------------------------------------------------|-------------|
| Generic Name: | Neurovascular Embolization Device | APR 24 2007 |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | Micro Therapeutics, Inc.<br>DBA ev3 Neurovascular<br>2 Goodyear<br>Irvine, California 92618 | |
| Contact: | Florin Truuvert | |

# Predicate Device:

| Number | Description | Predicate For | Clearance Date |
|-------------------------------|----------------------------------------|---------------------------|--------------------------------------------------|
| K041649 | Sapphire NXT Detachable<br>Coil System | FX Detachable Coil System | July 16, 2004 |
| K050543<br>K051425<br>K051560 | Nexus Detachable Coil<br>System | FX Detachable Coil System | April 27, 2005<br>June 22, 2005<br>June 28, 2005 |

## Device Description

The FX Detachable Coil System consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a handheld mechanical FX detachment actuator which facilities the release of the coil from the delivery pusher tip. The Nexus version of the FX Detachable coil is enlaced with absorbable polymer microfilaments. The FX Detachment Actuator is sold separately.

### Indication For Use

The FX Detachable Coils are intended for embolization of those intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neurovascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

## 510(k) Summarv

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K060747

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## Verification and Test Summary Table

| Bench Testing | Result |
|----------------------------------------------------|--------------------------|
| Dimensional & Visual Analysis | Met established criteria |
| Force Transfer | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| Reliability After Fatigue & Premature Detachment | Met established criteria |
| Tensile Strength of Delivery Pusher | Met established criteria |
| Tensile Strength at Detachment Zone | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL | Met established criteria |
| Delivery Pusher Distal Tip Buckling | Met established criteria |
| Delivery Pusher Distal Stiffness Profile | Met established criteria |
| Packaging Integrity | Met established criteria |
| Detachment Actuator Life Cycle and Reliability | Met established criteria |
| Time and Reliability of Detachment | Met established criteria |
| Radiopacity | Met established criteria |

## Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the FX detachable coil system compared with the predicate device NXT and Nexus detachable coil system.

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 processes. .

In summary, the FX Detachable Coil System 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micro Therapeutics, Inc., DBA ev3 Neurovascular % Mr. Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

APR 2 4 2007

Rc: K060747

Trade/Device Name: FX Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: March 30, 2007 Received: April 2, 2007

Dear Mr. Daughters:

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.

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

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Page 2 - Mr. Tom Daughters

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 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director
Division of General, Restorative

DEP DIR
4/24/07

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: FX Detachable Coil System

Indications For Use:

The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Prescription Use (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)

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

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510(k) Number 16060747