MReye Embolization Coils

K150931 · Cook Incorporated · KRD · Dec 18, 2015 · Cardiovascular

Device Facts

• Record ID: K150931
• Device Name: MReye Embolization Coils
• Applicant: Cook Incorporated
• Product Code: KRD · Cardiovascular
• Decision Date: Dec 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.

Device Story

MReye Embolization Coils are implantable devices used for peripheral arterial and venous vessel embolization. The device consists of coiled Inconel (nickel-chromium alloy) wire and synthetic fibers. It is delivered via a catheter; upon exiting the cartridge and catheter, the coil assumes a secondary curl diameter (0 to 45 mm) to occlude the target vessel. The device is used by clinicians in interventional procedures. The primary function is to promote embolization in the peripheral vasculature. The current submission expands the product line and updates MRI labeling to MR Conditional status. The device does not incorporate new technological characteristics compared to the predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically MRI testing to verify MR Conditional labeling parameters.

Technological Characteristics

Materials: Inconel (nickel-chromium alloy) wire and synthetic fibers. Form factor: Coiled wire, primary diameters 0.025-0.038 inches, extended lengths 1-20 cm, secondary curl diameters 0-45 mm. Principle: Mechanical vascular occlusion via coil deployment. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for peripheral arterial and venous vessel embolization procedures in patients requiring vascular 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 (K090624)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cook Incorporated Nozomi Yagi Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K150931

Trade/Device Name: MReye® Embolization Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 19, 2015 Received: October 20, 2015

Dear Nozomi Yagi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150931

Device Name MReye® Embolization Coils

Indications for Use (Describe)

MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 10.0 510(k) SUMMARY

# K150931

As required by 21 CFR §807.92 Date Prepared: April 3, 2015

#### I. SUBMITTER

| Applicant: | Cook Incorporated |
|-----------------------|----------------------------|
| Contact: | Nozomi Yagi |
| Applicant Address: | Cook Incorporated |
| | 750 Daniels Way |
| | Bloomington, IN 47404 |
| Contact Phone Number: | [phone] ext. 104511 |
| Contact Fax Number: | [phone] |

# II. DEVICE

Trade Name: Common Name: Classification Name: Regulation: Product Code

MReye® Embolization Coils Vascular Embolization Device Device, Vascular, For Promoting Embolization 21 CFR §870.3300 KRD

# III. PREDICATE DEVICE

The device subject of this submission is believed to warrant a determination of substantial equivalence to the predicate device, the Cook MReye Embolization Coils (K090624). This predicate has never been subject to a design-related recall, and no reference device was used in this submission.

#### IV. DEVICE DESCRIPTION

The MReye Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.025 to 0.038 inches, and the extended embolus lengths range from 1 to 20 cm. Upon exiting from the cartridge and the catheter. the coil forms a secondary curl diameter ranging from 0 (straight) to 45 mm.

# V. INDICATIONS FOR USE

MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modification included in this submission expands the using existing technology and does not include any new technological characteristics. The MReye® Embolization Coils are comparable to the predicate device. Specifically, the MReye® Embolization Coils are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate device.

In addition to product expansion, a revision to the MRI labeling to update MR Conditional language has been included in this submission. The modifications are adequately supported by testing.

#### VII. PERFORMANCE DATA

The following test was performed to determine the appropriate Magnetic Resonance Imaging information for the proposed device:

- . MRI Testing - MRI testing verifies that the implant will be labeled as "MR Conditional" with the applicable parameters described in the Instructions for Use.
#### VIII. CONCLUSIONS

The result of the testing provides reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements of its intended use. The proposed device also does not raise new questions of safety or effectiveness as compared to the predicate device and thus is substantially equivalent to the predicate device.