MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT

K080379 · Micrus Endovascular Corporation · HCG · Jun 30, 2008 · Neurology

Device Facts

• Record ID: K080379
• Device Name: MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
• Applicant: Micrus Endovascular Corporation
• Product Code: HCG · Neurology
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Traditional
• 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, 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

Micrus Deltapaq 10 Stretch-Resistant Microcoil System consists of embolic coil attached to Device Positioning Unit (DPU). Used by physicians for endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral vasculature embolizations. Device delivered via catheter to target site; DPU facilitates controlled placement and detachment of coil. Coil provides mechanical occlusion of target vessel or aneurysm. Single-use, sterile device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Embolic coil with Device Positioning Unit (DPU). Materials, dimensions, and construction methods identical to predicate. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (AVMs, AV 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 Stretch-Resistant Microcoil (K022420)

Submission Summary (Full Text)

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# JUN 3 0 2008

#### Summary of Safety and Effectiveness

| Submitter Name and<br>Address: | Micrus Endovascular Corp.<br>821 Fox Lane<br>San Jose, CA 95131 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Patrick Lee<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | February 22, 2008 |
| Device Name and<br>Classification: | Micrus Microcoil System<br>Common Name: Occlusion Coil<br>Trade Name: Micrus "Deltapaq 10 Stretch-Resistant" Microcoil<br>System, Catalog # DFS<br>Classification Name: Device, Neurovascular Embolization<br>Regulatory Class II |
| Predicate Devices: | Micrus Stretch-Resistant Microcoil, 510(k) no. K022420 |
| Device Description: | The Micrus Deltapaq 10 Stretch-Resistant Microcoil Systems<br>consists of an embolic coil ("Microcoil") attached to a Device<br>Positioning Unit (DPU) (single use, sterile) |
| Device Intended Use | The Micrus Microcoil Delivery System is intended for endovascular<br>embolization of intracranial aneurysms, other neurovascular<br>abnormalities such as arteriovenous malformations and<br>arteriovenous fistulae, and are also intended for arterial and venous<br>embolizations in the peripheral vasculature. |

### Comparison to Predicate Device:

The Micrus Deltapaq 10 Stretch-Resistant Microcoil System has shown substantial equivalence to the Micrus Stretch-Resistant Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The Deltapaq 10 Stretch-Resistant microcoils use 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

#### 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 Deltapaq 10 Stretch-Resistant Microcoil System is substantially equivalent to the predicate device in safety and effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2008

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

Re: K080379

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: April 2, 2008 Received: June 4, 2008

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 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 M Milliman

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

K080379

## Indications for Use

510(k) Number (if known):

Device Name: Micrus Microcoil Delivery Systems

Indications For Use:

The Micrus 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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K080379

Micrus Endovascular Corporation