EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150

K051179 · Boston Scientific Corp · NFA · Jun 8, 2005 · Cardiovascular

Device Facts

• Record ID: K051179
• Device Name: EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
• Applicant: Boston Scientific Corp
• Product Code: NFA · Cardiovascular
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The EZ Plus Retrieval Sheath is indicated for use with the Boston Scientific FilterWire EZ™ Embolic Protection System as an alternative method for retrieval and/or redeployment of a deployed FilterWire EZ device. Reference the FilterWire EZ Embolic Protection System Instructions for Use for indications, warnings and precautions for the system (see Appendix 2).

Device Story

The EZ Plus Retrieval Sheath is an accessory component for the FilterWire EZ Embolic Protection System. It features a retractable distal tip and marker band for fluoroscopic visualization. During interventional procedures, the sheath is advanced over the FilterWire EZ protection wire. The operator retracts the tip via a thumb piece to expose a cavity, allowing the filter to be resheathed. This process closes the filter loop, trapping embolic debris inside for safe removal from the patient. The device facilitates navigation through tortuous anatomy and crossing deployed stents. It is used by physicians in clinical settings to assist in the retrieval or repositioning of embolic protection devices, potentially reducing the risk of embolic events during vascular interventions.

Clinical Evidence

Bench testing only. Non-clinical tests were conducted in accordance with 21 CFR Part 58 (GLP) to verify that the device met design-input criteria for safety and effectiveness.

Technological Characteristics

Percutaneous catheter (21 CFR 870.1250). Features a retractable distal tip assembly connected to a proximal thumb piece via a retraction wire. Includes a radiopaque marker band for fluoroscopic visualization. Accessory component designed for use with the FilterWire EZ Embolic Protection System.

Indications for Use

Indicated for use with the Boston Scientific FilterWire EZ Embolic Protection System for the retrieval and/or redeployment of a deployed FilterWire EZ device in patients undergoing procedures requiring embolic protection.

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)

Submission Summary (Full Text)

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Special 510(k): Device Modification Special 910(R). Do 100% Protection System: EZ Plus Retrieval Sheath

## Section 5

## 510(k) Summary

## "510(k) Summary" as required by section 807.92(c)

#### 5.1 General Provisions

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>2011 Stierlin Court<br>Mountain View, CA 94043-4655, U.S.A. |
|---------------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person | Catherine A. Peters<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone] |
| Classification Name | 21 CFR 870.1250, Percutaneous Catheter |
| Common or Usual Name | Retrieval Sheath |
| Proprietary Name | Boston Scientific EZ Plus Retrieval Sheath |
| Manufacturing Facilities | Boston Scientific Corporation<br>2011 Stierlin Court<br>Mountain View, CA 94043-4655, U.S.A. |

#### Name of Predicate Device 5.2

Boston Scientific FilterWire EZ Embolic Protection System, (K032884)

#### Device Description 5.3

The Boston Scientific EZ Plus Retrieval Sheath, a separately packaged, accessory component of the Boston Scientific FilterWire EZ Embolic Protection System, is an easy exchange sheath with a retractable tip at the distal end. The retractable tip facilitates its ability to cross a deployed stent as well as to negotiate tortuous anatomy when retrieving the FilterWire EZ protection wire. The radiopaque retractable tip and marker band at the distal end of the EZ Plus Retrieval Sheath provide visualization of the device under fluoroscopic imaging. At the completion of the procedure, the EZ Plus Retrieval Sheath is advanced up the FilterWire to just proximal the deployed filter loop. The filter is resheathed into the distal end of the EZ Plus Retrieval Sheath and the entire system is then removed from the patient.

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#### 5.4 Intended Use

The EZ Plus Retrieval Sheath is indicated for use with the Boston Scientific FilterWire EZ™ Embolic Protection System as an alternative method for retrieval and/or redeployment of a deployed FilterWire EZ device. Reference the FilterWire EZ Embolic Protection System Instructions for Use for indications, warnings and precautions for the system (see Appendix 2).

#### Summary of Technological Characteristics ર્સ્ડ

The Boston Scientific EZ Plus Retrieval Sheath ("EZ Plus") is an accessory component to the FilterWire EZ Embolic Protection System cleared under K032884. The EZ Plus, built on core retrieval sheath technology, is an easy exchange sheath with a retractable tip at the distal end. The EZ Plus tip assembly is connected to a retractable thumb piece via a retraction wire.

The radiopaque retractable tip and marker band at the distal end provide visualization of the device under fluoroscopic imaging. At the completion of a procedure using the FilterWire EZ Embolic Protection System, the EZ Plus Retrieval Sheath is advanced over the FilterWire EZ protection wire, and the EZ Plus tip is retracted, providing access to a cavity which is used to retrieve the filter. The filter is then re-sheathed into the distal end of the EZ Plus Retrieval Sheath. As the filter retraction is initiated, the filter loop closes, trapping embolic debris inside the filter. The entire system is then removed from the patient.

With the addition of the EZ Plus Retrieval Sheath as an accessory component, the indications for use for the FilterWire EZ Embolic Protection System cleared under K032884 have not changed. Like the EZ Soft Tip and Bent Tip Retrieval Sheaths currently cleared under K032884, the EZ Plus Retrieval Sheath is intended for retrieval of a deployed FilterWire EZ protection wire. Also, like the EZ Soft Tip Retrieval Sheath, the EZ Plus Retrieval Sheath may be used for repositioning/redeployment during a procedure.

#### 5.6 Non-Clinical Test Summary

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 [Good Laboratory Practices (GLP)]. Specifically, non-clinical tests conducted for the EZ Plus Retrieval Sheath showed the device met its design-input criteria, and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

Boston Scientific Corporation c/o Ms. Catherine A. Peters Regulatory Affairs Specialist 2011 Stielin Court Mountain View, CA 94043-4655

K051179 Re:

> Trade/Device Name: EZ Plus Retrieval Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NFA Dated: May 5, 2005 Received: May 9, 2005

Dear Ms. Peters:

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.

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

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Page 2 -- Ms. Catherine A. Peters

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Section product radiation control provisions (Sections of Conceller as described in your device to Acel I his letter will anow you to oegin marketing of substantial equivalence of your device to a legally premarket nothcation. The PDA miding of bactualina vipes
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 If you desire specific advice ior your aconce to the regulation of the regulation entitled, Contact the Office of Complance at (210) = 6 cart 807.97). You may obtain " Misoranding by receience to promance notificas under the Act from the Division of Small other general information on your responsion.com and its toll-free number [phone] or Manufacturers, International and Oolsonhip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dinna R. Vuchnes

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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# KOSII19

Special 510(k): Device Modification FilterWire EZ™ Embolic Protection System: EZ Plus Retrieval Sheath

Indications For Use

Boston Scientific EZ Plus Retrieval Sheath Device Name:

### Indications for Use:

The indications for use for the EZ Plus Retrieval Sheath are as follows:

The EZ Plus Retrieval Sheath is indicated for use with the Boston Scientific FilterWire EZ™ Embolic Protection System as an alternative method for retrieval and/or redeployment of a deployed FilterWire EZ device.

Reference the FilterWire EZ Embolic Protection System Instructions for Use for indications, warnings and precautions for the system.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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