SPIDERX EMBOLIC PROTECTION DEVICE

K062201 · Ev3, Inc. · NFA · Aug 11, 2006 · Cardiovascular

Device Facts

• Record ID: K062201
• Device Name: SPIDERX EMBOLIC PROTECTION DEVICE
• Applicant: Ev3, Inc.
• Product Code: NFA · Cardiovascular
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

Device Story

SpideRX Embolic Protection Device is a percutaneously delivered distal embolic protection system. It consists of a nitinol mesh filter mounted on a convertible 190/320 cm PTFE-coated 0.014" stainless steel wire, accompanied by a dual-ended catheter for delivery and recovery. Used during coronary saphenous vein bypass graft procedures; the device functions as both an embolic filter and a guidewire. Operated by physicians in a clinical setting (catheterization lab). The filter captures thrombus/debris during angioplasty or stenting, preventing distal embolization. The device is removed after the procedure, carrying the captured material out of the vasculature. Benefits include reduced risk of distal embolic complications during coronary interventions.

Clinical Evidence

No clinical data provided. The submission relies on the substantial equivalence to the predicate device and labeling updates regarding compatibility with drug-eluting stents.

Technological Characteristics

Nitinol mesh filter; 190/320 cm PTFE-coated 0.014" stainless steel wire; dual-ended delivery/recovery catheter. Mechanical distal protection system. No software or electronic components.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty or stenting in coronary saphenous vein bypass grafts (vessel diameters 3.0-6.0 mm) to contain and remove embolic material. Not indicated for cerebral or peripheral vasculature.

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

• SpideRX Embolic Protection Device (K053195)

Submission Summary (Full Text)

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# 510(k) Summary SpideRXTM Embolic Protection Device

# 510(k) Number: K06220 |

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>4600 Nathan Lane North<br>Plymouth, MN 55442 |
| Official Contact: | Brenda Johnson<br>Sr. Regulatory Affairs Specialist<br>ev3 Inc.<br>9600 54th Avenue North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | SpideRXT™ Embolic Protection Device |
| Common Name/Usual Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Class: | Class II, 21 CFR 870.1250 |

## Predicate Devices:

SpideRX Embolic Protection Device (K053195)

#### Device Description:

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

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### Intended Use:

The SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

### Summary of Labeling Change:

The labeling has been modified to reflect use compatibility of the SpideRX Device with currently marketed drug-eluting stents.

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Food and Drug Administrat. 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Ms. Brenda Johnson Senior Regulatory Affairs Specialist ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K062201

> Trade/Device Name: ev3 Inc. SpideRX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Distal Embolic Protection Guidewire Regulatory Class: Class II Product Code: NFA Dated: July 27, 2006 Received: August 1, 2006

Dear Ms. Johnson

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 indications 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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be 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.

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Page 2 -- Ms. Brenda Johnson

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. product lauxiness on on 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 prorketed 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,

Bram D. Zuckerman, M.D.

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): _ KO6220)

Device Name: SpideRX™ Embolic Protection Device

Indications for Use:

The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic arotection system has not been established in the cerebral or peripheral vasculature.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number. K062201

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