MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR

K071246 · Micrus Endovascular Corporation · HCG · Jun 1, 2007 · Neurology

Device Facts

• Record ID: K071246
• Device Name: MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
• Applicant: Micrus Endovascular Corporation
• Product Code: HCG · Neurology
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Device Story

System consists of embolic microcoil attached to device positioning unit (DPU), connecting cable (CCB), and detachment control box (DCB). Used for endovascular embolization of intracranial aneurysms. Physician operates system to deliver and detach coils within aneurysm. DCB facilitates controlled detachment of coil. System components are single-use and sterile. Provides mechanical occlusion of aneurysm to prevent rupture or further growth.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises embolic microcoil, device positioning unit, connecting cable, and detachment control box. Materials and dimensions are consistent with predicate devices. Operates via endovascular delivery and electrical detachment mechanism.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients requiring such intervention.

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 (K002056)
• Micrus Microcoil Delivery System (K031578)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Submitter Name and Address: | Micrus Endovascular Corp.<br>821 Fox Lane<br>San Jose, CA 95131 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Patrick Lee, Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | May 1, 2007 |
| Device Name and<br>Classification: | Micrus Microcoil Delivery System<br>Common Name: Micrus Microcoil System<br>Classification Name: Device, Artificial Embolization<br>Product Code HCG<br>Regulatory Class II |
| Predicate Devices: | Micrus Microcoil Delivery System, 510(k) K002056<br>Micrus Microcoil Delivery System, 510(k) K031578 |
| Device Description: | The Micrus Microcoil Delivery System consists of<br>(1) An embolic coil ("Microcoil") attached to a Device<br>Positioning Unit (DPU) (single use, sterile).<br>(2) An Connecting Cable ("CCB")<br>(3) A Detachment Control Box ("DCB") |
| Device Intended Use | The Micrus MicroCoil Delivery System is intended for<br>endovascular embolization of intracranial aneurysms. |

## Comparison to Predicate Devices:

The Microcoil Delivery Systems with the new Detachment Control Box ("DCB") have shown substantial equivalence to the FDA-cleared and marketed Micrus Microcoil Delivery System in terms of intended use, design, material and method of construction, and dimensions. The modification has not altered the fundamental technology of the sponsor's predicate device.

## Conclusion:

Based upon the design, materials, function, intended use comparison with currently marketed device and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the new DCB of the Micrus Microcoil Delivery System is substantially equivalent to the predicate devices in safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2007

Micrus Endovascular Corporation % Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose. California 95131

Re: K071246

Trade/Device Name: Micrus Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization Regulatory Class: II Product Code: HCG Dated: May 1, 2007 Received: May 3, 2007

Dear Mr. Lee:

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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Page 2 - Mr. Patrick Lee

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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milliken

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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## Indications for Use

KO71246 510(k) Number (if known): ___

Device Name: Micrus Microcoil Delivery System

Indications For Use:

The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

K071246

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millikan

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

510(k) Number_