INTERLOCK FIBERED IDC OCCLUSION SYSTEM

K102912 · Boston Scientific · KRD · Mar 3, 2011 · Cardiovascular

Device Facts

• Record ID: K102912
• Device Name: INTERLOCK FIBERED IDC OCCLUSION SYSTEM
• Applicant: Boston Scientific
• Product Code: KRD · Cardiovascular
• Decision Date: Mar 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interlock 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

Interlock Fibered IDC Occlusion System consists of platinum-tungsten alloy coil with synthetic fibers for thrombogenicity; mechanically attached to delivery wire; contained in introducer sheath. Delivered under fluoroscopy via 0.021 in (0.53 mm) I.D. microcatheter. Interlocking wire design allows advancement, retraction, and withdrawal of coil prior to final deployment. Used in peripheral vasculature to obstruct or reduce blood flow. Provides controlled delivery for clinicians.

Clinical Evidence

Bench testing only. MR Conditional safety evaluated per ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06, and ASTM F2119-07 for 1.5T and 3.0T field strengths.

Technological Characteristics

Platinum-tungsten alloy coil; synthetic fibers for thrombogenicity; interlocking delivery wire mechanism. MR Conditional (1.5T/3.0T). Standards: ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06, ASTM F2119-07.

Indications for Use

Indicated for obstruction or reduction of blood flow in 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

• Fibered Interlocking Detachable Coil (Fibered IDC Occlusion System) (K060078)

Submission Summary (Full Text)

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# MAR - 3 2011

Premarket Notification 510(k) Detachable Platinum Coils

# Section 2

510(k) Summary

# (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

| Submitter's Name and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Debbie McIntire<br>Senior Regulatory Affairs Specialist<br>Boston Scientific<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Classification Name | Vascular embolization device |
| Product Code | KRD |
| Common or Usual Name | Fibered IDC |
| Proprietary Name | Interlock™ Fibered IDC™ Occlusion System |
| Name of Predicate Device | Fibered Interlocking Detachable Coil (Fibered IDC<br>Occlusion System) (K060078) |
| | |
| Device Description | The Interlock Fibered IDC Occlusion System<br>includes a coil (manufactured from platinum-<br>tungsten alloy) that is mechanically attached to a<br>coil delivery wire. This assembly is contained<br>within an introducer sheath. The platinum coil<br>contains synthetic fibers for greater<br>thrombogenicity. The Interlock Fibered IDC<br>Occlusion Coil is designed to be delivered under<br>fluoroscopy with a 0.0 21 in (0.53 mm) inner<br>diameter (I.D.) microcatheter (e.g. Renegade™<br>Microcatheter) with one or two radiopaque (RO)<br>tip markers. The interlocking delivery wire design<br>allows the coil to be advanced and retracted before<br>final placement in the vessel, thus aiding in more<br>controlled delivery including the ability to<br>withdraw the coil prior to deployment. |
| Intended Use | The Interlock Fibered IDC Occlusion System is a<br>modified interlocking detachable coil indicated to<br>obstruct or reduce rate of blood flow in the<br>peripheral vasculature. This device is not intended<br>for neurovascular use. |
| Non-Clinical and Clinical Test<br>Summary | Non-clinical testing demonstrates that the Interlock<br>Fibered IDC Occlusion System will not present<br>additional risk to a patient during a MRI procedure<br>in comparison to risks imposed by gravitational,<br>and other normal daily activities, or a temperature<br>rise that is experienced during a feverish condition.<br>The results of testing conducted under methods<br>described by ASTM F2182-02a, ASTM F2052-<br>06e1. ASTM F2213-06 and ASTM F2119-07 have<br>demonstrated that the Coils are MR Conditional<br>and can be scanned safely under a static magnetic<br>field of 1.5 Tesla or 3.0 Tesla.<br>Testing at field strengths other than 1.5 Tesla or 3<br>Tesla has not been performed to evaluate coil<br>migration or heating. |

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Date Prepared: September 2010

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image. The seal is black and white.

#### Public Health Service

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

Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

MAR - 3 2011

Re: K102912

Trade/Device Name: Interlock™ Fibered IDC™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: February 18, 2011 Received: February 22, 2011

Dear Ms. Pettit:

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 indives 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 Fedral 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, list in 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 micleading.

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

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Page 2 - Ms. Shannon Pettit

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 is 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 (reporting of medical device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dana R. Bohmer

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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### Section 1

## Indications for Use Statement

510(k) Number (if known): K102912

Device Name: Interlock™ Fibered IDC™ Occlusion System

Indications for Use:

The Interlock™ 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 Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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