COOK MREYE EMBOLIZATION COILS

K090624 · Cook, Inc. · KRD · Apr 2, 2009 · Cardiovascular

Device Facts

• Record ID: K090624
• Device Name: COOK MREYE EMBOLIZATION COILS
• Applicant: Cook, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cook MReye Embolization Coil is used for peripheral arterial and venous vessel embolization procedures.

Device Story

Cook MReye Embolization Coil is a vascular embolization device. The device consists of a coil pre-loaded into a cartridge for delivery via a microcatheter to a target site within peripheral arterial or venous vessels. It is intended for use by physicians in clinical settings to perform embolization procedures. The device functions by being deployed into the vessel to induce occlusion. It is a modification of existing embolization coil technology.

Clinical Evidence

Bench testing only. Testing included coil deformation, delivery friction, embolization fiber pull-out, and cannula-to-catheter delivery testing to verify design and performance requirements.

Technological Characteristics

Vascular embolization coil; pre-loaded in cartridge for microcatheter delivery. Class II device (21 CFR 870.3300, Product Code KRD).

Indications for Use

Indicated for peripheral arterial and venous vessel embolization procedures in patients requiring vessel occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

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 § 870.1(e).

Predicate Devices

• Cook MReye Embolization Coils (K052834)
• Cook Stainless Steel Embolization Coils (Pre-amendment)

Submission Summary (Full Text)

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Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009

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1090624

## 510(k) SUMMARY

APR - 2 2009

| Submitted By: Susanne Galin, RAC |
|----------------------------------|
| Regulatory Affairs Specialist |
| Cook Incorporated |
| 750 Daniels Way, P.O. Box 489 |
| Bloomington, IN 47402 |
| [phone] x 2296 |
| February 20, 2009 |

Device:

| Trade Name: | Cook MReye Embolization Coils |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|
| Proposed Classification Name: | Vascular embolization device<br>21 CFR §870.3300, Product Code KRD |
| Indications for Use: | The Cook MReye Embolization Coil is used for peripheral<br>arterial and venous vessel embolization procedures. |
| Predicate Devices: | Cook MReye Embolization Coils (K052834)<br>Cook Stainless Steel Embolization Coils (Pre-amendment) |

Device Description:

The Cook MReye Embolization Coil is a device used for peripheral arterial and venous vessel embolization procedures. The coil is pre-loaded into a cartridge to facilitate delivery into a microcatheter, which then delivers the coil to the embolization site.

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### Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009

# Substantial Equivalence:

The identical indications for use, technological characteristics, and similar dimensions of the Cook MReye Embolization Coils as compared to the predicate device supports a determination of substantial equivalence.

# Test Data:

The following testing data were presented to demonstrate that the Cook MReye Embolization Coils meet applicable design and performance requirements:

- Coil deformation testing .
- Delivery friction testing ●
- Embolization fiber pull-out testing ●
- . Cannula to catheter delivery testing

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated, Inc. c/o Ms. Susanne Galin, RAC Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

APR - 2 2009

Re: K090624

Cook MReye® Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: March 6, 2009 Received: March 9, 2009

Dear Mr. Galin:

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.

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Page 2 - Ms. Susanne Galin, RAC

Please be advised that FDA's issuance of a substantial equivalence determinátion 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. 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Bram D. Zuckerman, M.D.
Director

Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009

Indications for Use

K090624

510(k) Number (if known):

Device Name:

Cook MReye® Embolization Coil

Indications for Use:

The Cook MReye Embolization Coil is used for peripheral arterial and venous vessel embolization procedures.

Prescription Use _ XX (Per 21 CFR 801.109)

OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(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 Cardiovascular | |
| 510(k) number | K090621 |

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