FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

K052280 · Boston Scientific Corp · NFA · Nov 7, 2005 · Cardiovascular

Device Facts

• Record ID: K052280
• Device Name: FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: NFA · Cardiovascular
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Device Story

Temporary intra-vascular 0.014" guidewire filtration system; used during coronary saphenous vein bypass graft interventions. Device delivered via low-profile sheath; filter deployed distal to lesion to capture thrombus/debris during angioplasty or stenting. After procedure, retrieval sheath collapses filter loop to trap emboli; system removed from patient. Operated by interventional physicians in clinical settings. Benefits patient by preventing distal embolization of debris during vessel treatment. System includes protection wire (190/300 cm), delivery sheath, and retrieval sheaths.

Clinical Evidence

No clinical data provided; submission relies on substantial equivalence to a previously cleared predicate device.

Technological Characteristics

0.014" guidewire-based filtration system; radiopaque tip and filter loop; includes delivery and retrieval sheaths. Compatible with standard interventional devices. Materials include standard medical-grade components for intravascular use. No electronic components or software.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty or stenting in coronary saphenous vein bypass grafts (vessel diameters 3.5-5.5 mm). Contraindicated in patients with severe heparin allergy, bleeding diathesis, or disorders limiting anticoagulant therapy.

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

• Boston Scientific FilterWire EZ Embolic Protection System (K032884)

Reference Devices

• Boston Scientific extension wire (K970376)

Submission Summary (Full Text)

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K 052280

# Section 5

510(k) Summary

# (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

#### 5.1 General Provisions

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>2011 Stierlin Court<br>Mountain View, California 94043-4655 |
|---------------------------------|----------------------------------------------------------------------------------------------|
| Contact Person | Debbie McIntire<br>Senior Regulatory Affairs Specialist<br>[phone] |
| Classification Name | Device, Coronary Saphenous Vein Bypass Graft,<br>Temporary, For Embolization Protection |
| Common or Usual Name | Embolic Protection Guidewire |
| Proprietary Name | Boston Scientific FilterWire EZTM Embolic<br>Protection System |
| Manufacturing Facilities | Boston Scientific Corporation<br>2011 Stierlin Court<br>Mountain View, California 94043-4655 |

#### 5.2 Name of Predicate Device

Boston Scientific FilterWire EZ Embolic Protection System (K032884)

## 5.3 Device Description

The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire EZ protection wire. The 190 cm wire is compatible with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges.

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The FilterWire EZ protection wire is delivered through a low profile delivery sheath, which allows free rotational movement of the guide wire component. The tip of the protection wire and the filter loop are radiopaque. The filter is deployed distal to the lesion, and the delivery sheath removed, leaving only the filter and filter loop at the end of a standard 0.014" guide wire. Interventional devices, which are 0.014" guide wire compatible, may then be tracked over the FilterWire guide wire to treat the lesion.

After treating the lesion, all interventional devices are removed, and a retrieval sheath is advanced to collapse the filter loop, trapping any emboli caught during the procedure. The retrieval sheath and FilterWire are then removed from the patient simultaneously.

#### 5.4 Intended Use

The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

### 5.5 Summary of Labeling Change

The Filter Wire EZTM Embolic Protection System Directions for Use insert includes two new statements under the Contraindications section which are added to the presently commercialized Directions for Use. These statements contraindicate FilterWire EZ use in patients with severe allergy to heparin and in patients with bleeding diathesis or other disorders which limit the use of anticoagulant therapy.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Boston Scientific Corporation c/o Ms. Debbie McIntire Senior Regulatory Affairs Specialist 2011 Stierlin Court Mountain View, CA 94043-4655

Re: K052280 FilterWire EZTM Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NFA Dated: September 30, 2005 Received: October 3, 2005

Dear Ms. Brinza:

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. Diane Brinza

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,

uma R. Vochmer

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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510(k) Number (if known): _K052780

Device Name: FilterWire EZ™ Embolic Protection System

Indications for Use:

The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures with performing privatein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duane R. Viarner

(Division Sign-Off)

K052280 / S 1

Division of Cardiovascular Devices

10/25/05

510(k) Number KC 50 8 0