INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

K113651 · Boston Scientific Corporation · KRD · Jan 11, 2012 · Cardiovascular

Device Facts

• Record ID: K113651
• Device Name: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Jan 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.

Device Story

The Interlock-35 Fibered IDC Occlusion System is a vascular embolization device consisting of a platinum-tungsten alloy coil with synthetic fibers for increased thrombogenicity. The coil is mechanically attached to a delivery wire and housed within an introducer sheath. Used in clinical settings, the device is delivered under fluoroscopic guidance through a 5F selective diagnostic catheter. The interlocking delivery wire mechanism allows the clinician to advance, retract, and reposition the coil within the vessel prior to final deployment, providing controlled placement. The device is intended to obstruct or reduce blood flow in the peripheral vasculature, aiding in embolization procedures.

Clinical Evidence

No clinical data provided. Bench testing was not required as there were no physical modifications to the device; the submission was limited to labeling clarifications.

Technological Characteristics

Platinum-tungsten alloy coil with synthetic fibers; mechanically attached to delivery wire; delivered via 5F (1.70 mm) catheter; fluoroscopic visualization; non-active, mechanical device.

Indications for Use

Indicated for obstructing or reducing blood flow in peripheral vasculature during embolization procedures. 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

• Interlock-35 Fibered IDC Occlusion System (K112103)

Submission Summary (Full Text)

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## 长川3651

## 510(k) Summary
per 21 CFR §807.92 (c)

per 21 CFR §807.92 (c)

JAN 1 1 2012

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Harlan Jones<br>Regulatory Affairs Specialist II<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | December 08, 2011 |
| Trade Name | Interlock™-35 Fibered IDCT™ Occlusion System |
| Common Name | Vascular embolization device |
| Classification | Class II |
| Product Code | KRD, Vascular embolization devices<br>(21 CFR 870.3300) |
| Predicate Device | Interlock-35 Fibered<br>IDC Occlusion<br>System (Vascular<br>embolization device)<br>K112103 SE: 12 Aug 2011 |
| Reason for<br>Submission | The reason for this premarket notification is to seek<br>clearance for a revision to the Directions for Use (DFU) for<br>Boston Scientific Corporation's (BSC) Interlock™-35<br>Fibered IDCT™ Occlusion System (Vascular embolization<br>device). The device was previously cleared by FDA under<br>K112103 as Interlock™-35 Fibered IDCT™ Occlusion System<br>(Vascular embolization device). |

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| Device<br>Description | The Interlock-35 Fibered IDC Occlusion System includes a<br>coil manufactured from a platinum-tungsten alloy that is<br>mechanically attached to a coil delivery wire. This assembly<br>is contained within an introducer sheath. The platinum coil<br>contains synthetic fibers for greater thrombogenicity. The<br>Interlock-35 Fibered IDC Occlusion System is designed to<br>be delivered under fluoroscopy through a 5F (1.70 mm)<br>(0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen)<br>Imager™ II Selective Diagnostic. The interlocking delivery<br>wire design allows the coil to be advanced and retracted<br>before final placement in the vessel, thus aiding in more<br>controlled delivery including the ability to withdraw the coil<br>prior to deployment. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | The Interlock-35 Fibered IDC Occlusion System is indicated<br>for obstructing or reducing blood flow in the peripheral<br>vasculature during embolization procedures. This device is<br>not intended for neurovascular use. |
| Non-Clinical<br>Performance<br>Data | Non-clinical performance data was not required since there<br>were no changes made to the device. The modifications<br>made to the DFU do not change the intended use of the<br>device, but were made for clarity. |
| Conclusion | Modification of the Intended Use/Indications for Use<br>statement in the Interlock-35 DFU was made for clarity. No<br>contraindications have been added or deleted. Instructions<br>for use have been clarified and reworded. Minor<br>modifications to precaution and caution statements were<br>reworded for clarity and consistency. No other changes to<br>labeling have been made.<br>Based on the minor labeling modifications, and no changes<br>to the device, Boston Scientific determined that the<br>Interlock-35 Fibered IDC Occlusion System continues to be<br>appropriate for its intended use. |

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with a serpent entwined around it.

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

JAN 1 1 2012

Boston Scientific Corporation c/o Mr. Harlan Jones Regulatory Affairs Specialist II One Scimed Place Maple Grove, MN 55311

Re: K113651

Trade/Device Name: Interlock™-35 Fibered IDC™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: December 9, 2011 Received: December 12, 2011

Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass band in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conmisered prices 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 I ou may, merelors, manel a et include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Thease noter u, 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 may be subject to additions, 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 I lease be devised that I Drivination that your device complies with other requirements of the Act that I Dri has made a availations administered by other Federal agencies. You must or any I cuently statures and regularents, including, but not limited to: registration and listing (21 Comply will an the Not 8 requirements (01); medical device reporting (reporting of medical

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Page 2 - Mr. Harlan Jones

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Killham

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

Enclosure

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## Proposed Intended Use/Indications for Use

510(k) Number (if known): _K113651

Device Name: Interlock-35™ Fibered IDC™ Occlusion System

Proposed Intended Use/Indications for Use:

The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M Z Killham

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KIL 36 ST

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