COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL

K102714 · Boston Scientific Corp · KRD · Feb 11, 2011 · Cardiovascular

Device Facts

• Record ID: K102714
• Device Name: COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
• Applicant: Boston Scientific Corp
• Product Code: KRD · Cardiovascular
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Device Story

VortX-18 and VortX-35 series are fibered platinum-tungsten alloy coils used for peripheral vascular embolization. Available in multiple shapes (e.g., VortX, Diamond, Helical, Figure-8, Multi-Loop, Straight), the coils include an introducer and plunger for delivery through a microcatheter. The device is used by clinicians in a clinical setting to occlude vessels. This submission updates labeling to designate the coils as MR Conditional, allowing safe use in 1.5T or 3.0T MRI environments under specific field gradient conditions. The device provides mechanical occlusion to benefit patients requiring embolization.

Clinical Evidence

Bench testing only. Testing conducted per ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06, and ASTM F2119-07 demonstrated MR Conditional status for 1.5T and 3.0T static magnetic fields with a spatial gradient less than 25 T/m.

Technological Characteristics

Materials: Platinum-tungsten alloy coils with synthetic fibers. Form factor: Various shapes (VortX, Diamond, Helical, Figure-8, Multi-Loop, Straight). Connectivity: None. Energy source: None. Sterilization: Not specified. Standards: ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06, ASTM F2119-07.

Indications for Use

Indicated for arterial and venous embolizations 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

• Target Therapeutics Peripheral Coils (K914786)
• Target Therapeutics Fibered Platinum Coils (K955293)

Submission Summary (Full Text)

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FEB 1 1 201

# K | O 2714
04) Summary 510(k) Summary

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(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 | 1) 0.018 Fibered Platinum Coils<br>2) 0.035 Fibered Platinum Coils |
| Proprietary Name | 1) VortX-18TM, VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Loop-18, Complex Helical-18 Fibered Platinum Coil<br>2) VortXTM-35, 2D Helical-35 Fibered Platinum Coils |
| Names of Predicate Devices | 1) Target Therapeutics Peripheral Coils (K914786)<br>2) Target Therapeutics Fibered Platinum Coils (K955293) |
| Reason for Submission | Modifications to the device labeling related to MRI compatibility |
| Device Description | Boston Scientific's 0.018 Fibered Platinum<br>1)<br>Coils consist of platinum-tungsten alloy coils<br>with synthetic fibers and are available in six<br>different shapes; Vortx, Vortx Diamond,<br>Complex Helical, Figure-8, Multi-Loop and<br>Straight. The coil is provided with an<br>introducer that is secured at both ends by a<br>retaining clip during shipping and storage.<br>The coil plunger, supplied with the coil, is<br>used to push the coil out of the introducer and<br>into the microcatheter. |
| | Boston Scientific VortX-35 and 2D Helical-35<br>2)<br>Fibered Platinum Coils are helically-shaped<br>platinum-tungstent alloy coils with synthetic<br>fibers. The coils are provided with an<br>introducer that is secured at both ends by a<br>retaining clip during shipping and storage. A<br>coil plunger, supplied with the coil, is used to<br>push the coil out of the introducer and into the<br>catheter. |
| Intended Use | Boston Scientific's 0.018 and 0.035 Fibered<br>Platinum Coils are intended for arterial and venous<br>embolizations in the peripheral vasculature. |
| Non-Clinical and Clinical Test<br>Summary | Non-clinical testing demonstrates that the Vortx-<br>18, Vortx Diamond-18, Straight-18, Figure 8-18,<br>Multi-Loop-18, Complex Helical-18, Vortx-35 and<br>2D Helical-35 Fibered Platinum Coils will not<br>present additional risk to a patient during a MRI<br>procedure in comparison to risks imposed by<br>gravitational, and other normal daily activities, or a<br>temperature rise that is experienced during a<br>feverish condition. The results of testing<br>conducted under methods described by ASTM<br>F2182-09, ASTM F2052-06e1, ASTM F2213-06<br>and ASTM F2119-07 have demonstrated that the<br>Coils are MR Conditional and can be scanned<br>safely under a static magnetic field of 1.5 Tesla or<br>3.0 Tesla in normal operating mode,and in a static<br>magnetic field gradient less than 25 T/m.<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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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 stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

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

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#### Re: K102714

VortXTM-18, VortXTM Diamond-18, Straight-18, Figure 8-18, Multi-Loop-18, and Complex Helical-18 Febered Platinum Coils VortX™-35 and 2D Helical-35 Fibered Platinum Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Device, Embolization, Vascular Regulatory Class: Class II (two) Product Code: KRD Dated: January 6, 2011 Received: January 7, 2011

Dear Ms. Pettit:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave rovewod your occasion or (-) fe 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 encreated of the enactment date of the Medical Device Amendments, or to conninered print to 1125 20, 2017 11:12 provisions of the Federal Food, Drug, devices that have boon 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, morelove, mains of the Act include requirements for annual registration, listing of genoral controls provisions practice, labeling, and prohibitions against misbranding and de rices, good mananablaring practice, and evaluate information related to contract liability addition. Ticasonote. ODAY as , 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 If your device is classified (500 above) and interest 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'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); 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dina R. Vahmir

A 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):

VortX-18TM , VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Device Name: Loop-18, Complex Helical-18 Fibered Platinum Coil and VortXTM-35, 2D Helical-35 Fibered Platinum Coils

Indications For Use:

Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

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)

Duana R. Vihmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102714

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