MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC

K063653 · Micrus Endovascular Corporation · HCG · Jan 17, 2007 · Neurology

Device Facts

• Record ID: K063653
• Device Name: MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
• Applicant: Micrus Endovascular Corporation
• Product Code: HCG · Neurology
• Decision Date: Jan 17, 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

The Micrus Cashmere-14 MicroCoil System is an implantable embolic device used for the endovascular treatment of intracranial aneurysms. It consists of an embolic microcoil attached to a single-use, sterile Device Positioning Unit (DPU). The device is deployed by a physician via an endovascular approach to occlude the aneurysm, thereby reducing the risk of rupture or further growth. The system is designed to be delivered through a microcatheter to the target site. It functions as a mechanical implant to promote embolization within the aneurysm sac.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by design, material, and functional comparisons, as well as non-clinical bench testing.

Technological Characteristics

The device is a neurovascular embolization coil. It consists of an embolic microcoil and a delivery positioning unit. Materials, dimensions, and construction methods are consistent with predicate microcoil systems. It is a sterile, single-use device.

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 Stretch-Resistant Microcoil (K022420)
• Micrus Microcoil Delivery System (K002056)
• Boston Scientific GDC 360 Soft SR (K042539)
• Cordis Trufill DCS Orbit Detachable Coil (K032553)

Submission Summary (Full Text)

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### 1.4 Summary of Safety and Effectiveness

| Submitter Name and<br>Address: | Micrus Endovascular Corp.<br>821 Fox Lane<br>San Jose, CA 95131 | | JAN 17 2007 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact Name: | Patrick Lee, Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Preparation Date: | December 5, 2006 | | |
| Device Name and<br>Classification: | Micrus Microcoil System "Cashmere"<br>Common Name: Micrus Microcoil System "Cashmere"<br>Classification Name: Device, Artificial Embolization | | |
| | Regulatory Class II | | |
| Predicate Devices: | Micrus Stretch-Resistant Microcoil, 510(k) no.K022420<br>Micrus Microcoil Delivery System, 510(k) no. K002056<br>Boston Scientific GDC 360 Soft SR, 510(k) no. K042539<br>Cordis Trufill DCS Orbit Detachable Coil, 510(k) no.K032553 | | |
| Device Description: | The Micrus Cashmere-14 MicroCoil System consists of an<br>embolic coil ("MicroCoil") attached to a Device Positioning<br>Unit (DPU) (single use, sterile). | | |
| Device Intended Use | The Micrus MicroCoil Delivery System is intended for<br>endovascular embolization of intracranial aneurysms. | | |

#### Comparison to Predicate Devices:

The Micrus Cashmere-14 Microcoil Systems have shown substantial equivalence to the Micrus SR Helical-18 Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, and coil length. The Cashmere-14 Microcoil system uses the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device

The Micrus Cashmere-14 Microcoil System have also shown substantial equivalence to the Boston Scientific GDC 360 and Cordis Orbit microcoil predicates in terms of

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intended use and design, material of construction, implant dimensions including wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, and coil length.

### Conclusion:

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Cashmere-14 Microcoil System is substantially equivalent to the predicate devices in safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 1 7 2007

Re: K063653

Trade/Device Name: Cashmere-14 MicroCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: December 6, 2006 Received: December 8, 2006

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

Sincerely yours,

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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K06361\$\overline{3}\$

# Indications for Use

510(k) Number (if known): _

Micrus Microcoil System . "Cashmere" Device Name: _______________

Model #: SRC140512-20, SRC140615-20, SRC140717-20, SRC140820-20,

SRC140922-20, SRC141025-20, SRC141127-20, SRC141230-20

Indications For Use:

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

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

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)

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

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510(k) Number

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