MICRUS MICROCOIL SYSTEMS

K073442 · Micrus Endovascular Corporation · HCG · Feb 26, 2008 · Neurology

Device Facts

• Record ID: K073442
• Device Name: MICRUS MICROCOIL SYSTEMS
• Applicant: Micrus Endovascular Corporation
• Product Code: HCG · Neurology
• Decision Date: Feb 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

Device Story

System consists of embolic coil (Microcoil) attached to Device Positioning Unit (DPU). Used for endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral vascular embolizations. Operated by physicians in clinical settings. Device facilitates mechanical occlusion of vascular structures to treat aneurysms and malformations. Single-use, sterile delivery system.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarities to predicate devices.

Technological Characteristics

System comprises embolic coil and Device Positioning Unit (DPU). Materials, construction, packaging, and sterilization methods are identical to predicate devices. Mechanical delivery system; no software or electronic components.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), 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

• Micrus® Microcoil Delivery System (K070707)
• Micrus® Microcoil Delivery System (K031578)
• Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (K962503)
• Cordis Neurovascular, Trufill DCS Detachable Coil (K071962)

Submission Summary (Full Text)

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KO 73442

Micrus Microcoil Delivery System 510(k) Premarket Notification

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#### 5.0 510(k) Summary

# Micrus Endovascular Corporation Micrus® Microcoil Delivery System

FES 26 - 2

This 510(k) Summary for the Microcoil Delivery System is submitted in accordance with the requirements of 21 C.F.R. § 807.92.

# GENERAL INFORMATION

| Manufacturer: | Micrus Endovascular Corporation<br>821 Fox Lane<br>San Jose, California 95131<br>Phone: [phone]<br>Est. Registration No. 2954740 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julia Gross |

| Contact Person: | Julia Gross |
|-----------------|-----------------------------------------|
| | Director, Regulatory & Clinical Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| | [e-mail] |

December 6, 2007 Date Prepared:

# DEVICE CLASSIFICATION

| Classification: | Class II |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Trade Name: | Micrus® Microcoil Delivery System |
| Generic/Common Name: | Neurovascular embolization device (21 CFR § 882.5950)<br>Vascular embolization device (21 CFR § 870.3300) |

# PREDICATE DEVICES

Micrus® Microcoil Delivery System (reference: K070707) Micrus® Microcoil Delivery System (reference: K031578) Boston Scientific / Target Therapeutics, Guglielmi Detachable Coil (reference: K962503) Cordis Neurovascular, Trufill DCS Detachable Coil (reference: K071962)

#### INTENDED USE

The Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

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Micrus Microcoil Delivery System 510(k) Premarket Notification

e73442

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### DEVICE DESCRIPTION

The Micrus Microcoil System cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).

### SUBSTANTIAL EQUIVALENCE

The previously cleared Microcoil Delivery System is substantially cquivalent to the Boston Scientific / Target Therapeutics Gugliclmi Detachable Coil and the Cordis Neurovascular Trufill DCS Detachable Coil systems in terms of intended use, design, specifications, and materials. These systems are all intended for use in the embolization of aneurysms. The predicate devices have additional indications in their labeling; specifically, embolization in the peripheral vasculature. The Microcoil Delivery System uses the same methods and materials in construction, packaging, and sterilization as its predicates. The modification to the intended use statement has not altered the fundamental technology of the Micrus devices.

### CONCLUSION

As described in this 510(k) Summary, Micrus Endovascular Corporation considers the Micrus® Microcoil Delivery System to be substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2008

Micrus Endovascular Corporation % Ms. Julia Gross Director, Regulatory and Clinical Affairs 821 Fox Lane San Jose, California 95131

Re: K073442

Trade/Device Name: Micrus Microcoil Delivery Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 6, 2007 Received: December 7, 2007

Dear Ms. Gross:

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 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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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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Micrus Microcoil Delivery System 510(k) Premarket Notification

K073442

#### Indications for Use 4.0

510(k) Number (if known): _

Micrus Microcoil Delivery Systems Device Name:

# Indications For Use:

The Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marle M. Millan

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

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**510(k) Number** K073442

Micrus Endovascular Corporation