FIBERED IDC OCCLUSION SYSTEM

K060078 · Boston Scientific Corporation · KRD · Jan 31, 2006 · Cardiovascular

Device Facts

• Record ID: K060078
• Device Name: FIBERED IDC OCCLUSION SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

Device Story

Fibered IDC Occlusion System is a modified interlocking detachable coil designed to obstruct or reduce blood flow in peripheral vasculature. Device is used by physicians in clinical settings. It functions as an embolic agent to occlude vessels. Biocompatibility is verified per ISO 10993. Device is not intended for neurovascular applications.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Modified interlocking detachable coil; peripheral vascular embolization; biocompatible materials tested per ISO 10993.

Indications for Use

Indicated for obstruction or reduction of blood flow in the peripheral vasculature. Not for neurovascular use.

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

• Interlocking Detachable Coil System (IDC System)
• Guglielmi Detachable Coil (GDC) Systems (GDC and GDC VortX)
• VortX-18 Pushable Coils
• VortX-18 Diamond Pushable Coils

Submission Summary (Full Text)

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JAN 3 1 2006

## Special S I 0(k)
Fibered Interlocking Detachable Coil (Fibered IDC Occlusion System)
Boston Scientific Corporation ~ Confidential

## 510(k) Summary

| General<br>Provisions | Trade Name: To be determined |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: Arterial Embolization Device |
| Name of<br>Predicate<br>Devices | Interlocking Detachable Coil System (IDC System), Guglielmi Detachable<br>Coil (GDC) Systems (GDC and GDC VortX) and the VortX-18 and VortX-<br>18 Diamond Pushable Coils. |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Fibered IDC Occlusion System is a modified interlocking detachable coil<br>indicated to obstruct or reduce rate of blood flow in the peripheral<br>vasculature. This device is not intended for neurovascular use. |
| Biocompatibility | The Fibered IDC™ Occlusion System has been tested for biocompatibility<br>per ISO 10993. All data demonstrate this device is biocompatable for its<br>intended use. |
| Summary of<br>Substantial<br>Equivalence | The Fibered IDC™ Occlusion System has been tested and compared to the<br>predicate device. All data gathered demonstrate this device as substantially<br>equivalent. No new issues of safety or efficacy have been raised. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

Boston Scientific Corporation c/o Ms. Christine M. Cameron Regulatory Specialist 100 Boston Scientific Way Mariborough, MA 01752

Re: K060078

Fibered IDC Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (Two) Product Code: KRD Dated: January 9, 2006 Received: January 10, 2006

Dear Ms. Cameron:

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. Iisting 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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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. 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.

uma R. buchner

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

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Special 510(k) Fibered Interlocking Detachable Coil (Fibered IDC Occlusion System) Boston Scientific Corporation ~ Confidential

## Indications For Use

| 510(k) Number (if known) | Unknown<br>K060078 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Fibered IDC™ Occlusion System |
| Indications for Use | The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use. |

Prescription Usc X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vachner

(Division Sign-Off) (Division Organization Devices

510(k) number K060078