INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM

K132578 · Boston Scientific Corp · KRD · Sep 13, 2013 · Cardiovascular

Device Facts

• Record ID: K132578
• Device Name: INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Special
• 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

The Interlock Fibered IDC Occlusion System is a vascular embolization device consisting of 0.018-inch platinum-tungsten alloy coils with synthetic fibers for increased thrombogenicity. The coil is mechanically attached to a delivery wire and housed in an introducer sheath. Used in clinical settings under fluoroscopic guidance, the device is delivered via a 0.021-inch inner diameter microcatheter. The interlocking mechanism allows the clinician to advance, retract, and reposition the coil within the vessel before final detachment. This controlled delivery enables precise placement to obstruct or reduce blood flow in peripheral vessels, providing a therapeutic benefit for conditions requiring vessel occlusion.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, reactivity, toxicity, pyrogenicity, hemolysis, complement activation, implantation, genotoxicity) and in-vitro performance (anchorability, deliverability/pushability, fiber retention, stretch resistance, microcatheter compatibility).

Technological Characteristics

Platinum-tungsten alloy coil with synthetic fibers; 0.018-inch system compatible; interlocking detachable mechanism; delivered via 0.021-inch ID microcatheter; fluoroscopic visualization; non-active, mechanical device.

Indications for Use

Indicated for patients requiring 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

• Interlock -18 Fibered IDC (K102912)
• Occlusion System (K060078)

Submission Summary (Full Text)

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25-78

SEP 1 3 2013

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## 510(k) Summary

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per 21 CFR §807.92

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: [phone]<br>763-494-2222<br>Fax: | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Contact Name<br>and<br>Information | Todd Kornmann<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>763-494-2222<br>Fax:<br>e-mail: [e-mail] | |
| Date Prepared | 15 August 2013 | |
| Proprietary<br>Name | Interlock™ 018 Fibered IDC ™ Occlusion System | |
| Common Name | Vascular embolization device | |
| Product Code | KRD | |
| Classification | Class II, 21 CFR Part 870.3300 | |
| Predicate<br>Devices | K102912, March 3, 2011<br>Interlock -18 Fibered IDC<br>K060078, January 31, 2006<br>Occlusion System | |
| Device<br>Description | The 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a<br>product line consisting of 0.018 inch (0.457 mm) system compatible<br>fibered interlocking detachable coils. The Interlock Fibered IDC Occlusion<br>System includes a coil (manufactured from platinum tungsten alloy) that is<br>mechanically attached to a coil delivery wire. This assembly is contained<br>within an introducer sheath. The platinum coil contains synthetic fibers for<br>greater thrombogenicity. The Interlock Fibered IDC Occlusion Coil is<br>designed to be delivered under fluoroscopy with a 0.021 inch (0.53 mm)<br>inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with<br>one or two radiopaque (RO) tip markers. The interlocking delivery wire<br>design allows the coil to be advanced and retracted before final placement<br>in the vessel, thus aiding in more controlled delivery including the ability to<br>withdraw the coil prior to deployment. | |
| Intended Use/<br>Indications for<br>Use | The Interlock Fibered IDC Occlusion System is a modified interlocking<br>detachable coil indicated to obstruct or reduce rate of blood flow in the<br>peripheral vasculature. This device is not intended for neurovascular use. | |
| Comparison of<br>Technological<br>Characteristics | The proposed line extension of the 018 Spiral / Helical 2D Interlock<br>Fibered IDC Occlusion System incorporates substantially equivalent<br>design, packaging, fundamental technology, manufacturing processes,<br>sterilization process and intended use as those featured in the predicate<br>BSC Interlock Fibered IDC Occlusion System. | |
| Performance<br>Data | Determination of substantial equivalence for the 018 Spiral / Helical 2D<br>Interlock Fibered IDC Occlusion System bench testing is based on an<br>assessment of non-clinical bench and biocompatibility testing. The resultsof these tests provide reasonable assurance that the proposed device has<br>been designed and tested to assure conformance to the requirements for<br>its intended use. No new safety or performance issues were raised during<br>the testing and, therefore, these devices may be considered substantially<br>equivalent to the predicate devices. | |
| | The following biocompatibility and chemical characterization tests were<br>completed on the 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion<br>System: | |
| | Cytotoxicity | Hemolysis (Extract Method) |
| | Sensitization | Complement Activation |
| | Intracutaneous Reactivity | Implantation |
| | Acute Systemic Toxicity | Genotoxicity (Ames Assay and<br>Mouse Lymphoma) |
| | Materials Mediated Pyrogenicity | Subacute Toxicity (IP and IV) |
| | USP Physicochemical | Latex |
| | Partial Thromboplastin Time | |
| | The following in-vitro performance tests were completed on the 018 Spiral<br>/ Helical 2D Interlock Fibered IDC Occlusion System: | |
| | Anchorability | Deliverability/Pushability |
| | Fiber Retention | Stretch Resistance |
| | Microcatheter Compatibility (lumen) | |
| Conclusion | The modifications do not affect the intended use or alter the fundamental<br>scientific technology of the predicate Boston Scientific Interlock Fibered<br>IDC Occlusion System (K102912, cleared March 3, 2011 and K060078,<br>cleared January 31, 2006). | |
| | Based on the indications for use, technological characteristics, safety and<br>performance testing, the proposed line extension of the 018 Spiral /<br>Helical 2D Interlock Fibered IDC Occlusion System is appropriate for the<br>intended uses and are considered to be substantially equivalent to the<br>predicate Interlock Fibered IDC Occlusion Systems (K102912, cleared<br>March 3, 2011 and K060078, cleared January 31, 2006). | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in a bold, flowing line.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go05 Silver Spring, MD 20993-0002

#### September 13, 2013

Boston Scientific Corporation C/O Todd Kornmann One Scimed Place Maple Grove, MN 55311

Re: K132578

Trade/Device Name: Interlock™ - 18 Fibered ICD™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 15, 2013 Received: August 16, 2013

Dear Mr. Kornmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to to to to the determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enotiment date of the Medical Device Amendments. or to continered prof to may 2011 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 cither 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 that FDA has made a determination that your device complics with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any I cachar statues and regionnents. including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set ocelection in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic (200 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Todd Kornmann

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

### Melissa A. Torres -S

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

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### Indications for Use

510(k) Number (if known): _ K132578

Device Name: Interlock™ -18 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 × (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)

# Melissa A. Torres -S