SPIDERFX EMBOLIC PROTECTION DEVICE

K063204 · Ev3, Inc. · NTE · Nov 14, 2006 · Cardiovascular

Device Facts

• Record ID: K063204
• Device Name: SPIDERFX EMBOLIC PROTECTION DEVICE
• Applicant: Ev3, Inc.
• Product Code: NTE · Cardiovascular
• Decision Date: Nov 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Device Story

Percutaneously delivered distal embolic protection system; used during carotid artery angioplasty and stenting. Device consists of nitinol mesh filter mounted on 0.014" stainless steel guidewire (PTFE-coated) and dual-ended delivery/recovery catheter. Operates as guidewire and embolic filter; captures thrombus/debris during procedures. Used by physicians in clinical settings. Provides embolic protection to reduce risk of distal embolization during intervention. Benefits patient by containing embolic material, potentially reducing stroke risk.

Clinical Evidence

Non-clinical verification and validation included in vitro bench testing, package integrity testing, and in vivo animal studies. No human clinical trial data reported.

Technological Characteristics

Rapid exchange distal embolic protection device. Materials: nitinol mesh filter, PTFE-coated stainless steel guidewire. Compatible with 0.014"/0.018" primary guidewires. Features: 190 cm or 190/320 cm convertible wire, 23 gauge blunt tip needle, radiopaque mouth marker. Mechanical sensing/capture principle. No software or energy source.

Indications for Use

Indicated for patients undergoing angioplasty and stenting in carotid arteries with vessel diameters between 3.0mm and 7.0mm, requiring containment and removal of embolic material.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• SpideRXTM Embolic Protection Device (K052659)

Submission Summary (Full Text)

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# SpiderFXTM Embolic Protection Device

**510(k) Number:** K063204

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.

# General Provisions:

| Submitter's Name | ev3 Inc.<br>9600 54th Avenue North<br>Plymouth, MN 55442 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tamima Itani, Ph.D., RAC<br>Vice President<br>Clinical & Regulatory Affairs<br>ev3 Inc.<br>9600 54th Avenue North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | SpiderFXTM Embolic Protection Device |
| Common Name/Usual Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Class: | Class II, 21 CFR 870.1250 |

# Predicate Devices:

SpideRXTM Embolic Protection Device (K052659)

# Device Description:

The SpiderFXTM Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 190/320 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.

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# Intended Use:

The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

# Summary of Technological Characteristics:

The SpiderFX™ Embolic Protection Device is a rapid exchange distal embolic protection device that is compatible with 0.014"/0.018" primary guidewires and utilizes a nitinol mesh filter to capture debris. The SpiderFX Device is substantially equivalent to the SpideRX™ Device (K052659) with several modifications, including the addition of a 23 gauge blunt tip needle and a rapid exchange length (190 cm) Capture Wire, and modifications to the radiopaque mouth marker, flexible connector, and marking of the primary wire exit port.

### Summary of Testing:

Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use.

# Statement of Equivalence:

The SpiderFX™ Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 4 2006

ev3, Inc. c/o Tamima Itami, Ph.D. Vice President, Clinical & Regulatory Affairs 9600 54th Avenue North Plymouth, MN 55442

Re: K063204 SpyderFX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: NTE Dated: October 20, 2006 Received: October 23, 2006

Dear Dr. Itami:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed 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 encreate) is segmy and cate of the Medical Device Amendments, or 10 connineres phor to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have occh rechasined in assire approval of a premarket approval application (PMA). and Cosmetic Hot (rec) that to device, subject to the general controls provisions of the Act. The I ou may, mercloro, manel the Act include requirements for annual registration, listing of general controls proficiouring 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 If your device is olassified (600 a00 0) and . Existing major regulations affecting your device can may be subject to back as a such as a most of the 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.

Dmia R. Holmes

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): 166 3204

Device Name: SpiderFX™ Embolic Protection Device

Indications for Use:

The SpiderFXTM Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Nura R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_£063204

Confidential

ev3 Inc.