FLIPPER DETACHABLE EMBOLIZATION COILS

K063619 · Cook, Inc. · KRD · Dec 20, 2006 · Cardiovascular

Device Facts

• Record ID: K063619
• Device Name: FLIPPER DETACHABLE EMBOLIZATION COILS
• Applicant: Cook, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for arterial and venous embolization in the peripheral vasculature.

Device Story

Flipper Detachable Embolization Coil (Inconel) is a vascular embolization device; used for arterial and venous embolization in peripheral vasculature. Device consists of Inconel coil with synthetic fibers; pre-loaded in shipping cannula. Operated by physician using angiographic catheter; deployment achieved by unscrewing threads between coil and delivery wire. Device provides mechanical occlusion of vessels; intended for one-time use. Bench testing confirmed performance including coil deformation, tensile strength, friction, fiber pull-out, detachment reliability, and MR compatibility.

Clinical Evidence

No clinical data. Bench testing only: coil deformation, wire tensile strength, delivery friction, fiber pull-out, detachment reliability, and magnetic resonance (MR) testing.

Technological Characteristics

Inconel embolization coil; 0.035-inch wire diameter; curled shape; 3-8 mm size range; synthetic fibers; mechanical detachment via unscrewing delivery wire; supplied sterile; single-use.

Indications for Use

Indicated for arterial and venous embolization in the peripheral vasculature.

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

• Flipper Detachable Embolization Coil (stainless steel) (K993455)
• MReye Embolization Coil (K052834)

Submission Summary (Full Text)

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Special 510(k): Device Modification Flipper Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006

KO63619 2. Lot2

# 510(k) SUMMARY

| Submitted By: | Lisa Webb, MBA, RAC<br>Regulatory Affairs Manager<br>Cook Incorporated<br>750 Daniels Way, P.O. Box 489<br>Bloomington, IN 47402<br>[phone] x 2643<br>December 4, 2006 |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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DEC 2 0 2006

### Device:

| Trade Name: | Flipper® Detachable Embolization Coil (Inconel) |
|-------------------------------|-----------------------------------------------------------------------------|
| Proposed Classification Name: | Device, Vascular, Embolization<br>21 CFR 870.3300, KRD |
| Indications for Use: | Used for arterial and venous embolization in the peripheral<br>vasculature. |

### Predicate Devices:

The Flipper® Detachable Embolization Coil (Inconel) is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Flipper® Detachable Embolization Coil (stainless steel) and MReye® Embolization Coil.

# Device Description:

The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.

### Substantial Equivalence:

Cook Incorporated currently markets the Flipper® Detachable Embolization Coil (stainless steel—K993455) and the MReye® Embolization Coil (K052834), to which the Flipper® Detachable Embolization Coil (Inconel) is substantially equivalent. The similar indications for use, materials of construction, and technological characteristics of the Flipper® Detachable Embolization Coil (Inconel) as compared to the predicate devices support a determination of substantial equivalence.

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Special 510(k): Device Modification Flipper® Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006

-063619

# Test Data:

Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil . (Inconel) meets applicable design and performance requirements.

- Coil Deformation Testing ■
- Wire Tensile Strength 트
- Delivery Friction Testing 트
- 피 Fiber Pull-Out Testing
- Detachment Reliability Testing
- Magnetic Resonance (MR) Testing ■

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2006

Cook, Incorporated c/o Lisa Webb, MBA, RAC Regulatory Affairs Manager P.O. Box 489 Bloomington, IN 47402-0489

Re: K063619

Trade/Device Name: Flipper® Detachable Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Embolectomy Coil Regulatory Class: II (two) Product Code: KRD Dated: December 4, 2006 Received: December 5, 2006

Dear Ms. Webb:

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, 7 rug, 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, UDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Webb

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Blymmimor for

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): | K063619 |
|---------------------------|-----------------------------------------------------------------------------|
| Device Name: | Flipper ^® Detachable Embolization Coil (Inconel) |
| Indications for Use: | Used for arterial and venous embolization in the peripheral<br>vasculature. |

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 Devices (a561) 510(k) Number