The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the artery at the site of filter loop placement should be between 2.25 mm and 5.5 mm.

The safety and effectiveness of this device as an embolic protection system has not been established in cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

Device Description

The subject FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) consists of the same four main components as the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984. These components are:

· A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow.
· An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion.
· An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated.
· A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Boston Scientific FilterWire EZ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for a new AI/software device.

Therefore, the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance metrics are not applicable to this regulatory document.

The document states that the new device is substantially equivalent to a previously cleared device (K051984) and that "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use." However, it does not provide specific acceptance criteria or detailed study results in the format requested for an AI/software device.

Here's an attempt to structure the available information, noting the inapplicability of many requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a non-software medical device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting "design-input criteria" through non-clinical testing. Specific quantitative acceptance criteria and performance metrics for the device's function (e.g., filter efficiency, guidewire flexibility) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this is not an AI/software device requiring a test set of data. Non-clinical (in-vitro and in-vivo) testing was performed, but specific sample sizes for these tests are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is not an AI/software system that uses ground truth labels established by experts on a test set.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study?

No. This is not an AI/software device, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study?

No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it's not an AI/software device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Relevant Information from the Document:

While the specific details requested for an AI/software device are not present, the document provides the following:

Device: Boston Scientific FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm)
Purpose of Submission: To demonstrate substantial equivalence to a predicate device (FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984).
Performance Evaluation: "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use."
Testing Types Mentioned: In-vitro testing, in-vivo testing, biocompatibility, and packaging.
Compliance: Where appropriate, testing conformed to the requirements of 21 CFR Part 58, Good Laboratory Practices (GLP).

Summary

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K061332
AUG 11 2006

Section 5 510(k) Summary

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

5.1 General Provisions

Submitter's Nameand Address	Boston Scientific Corporation2011 Stierlin CourtMountain View, CA 94043-4655, U.S.A.
Contact Person	Debbie McIntireSenior Regulatory Affairs SpecialistTel: (650) 623-1703Fax: (650) 623-1610
Classification Name	21CFR870.1250, Percutaneous Catheter
Common or Usual Name	Distal embolic protection guide wire
Proprietary Name	Boston Scientific FilterWire EZ Embolic ProtectionSystem
Manufacturing Facilities	Boston Scientific Corporation2011 Stierlin CourtMountain View, CA 94043-4655, U.S.A.

5.2 Name of Predicate Device

The Boston Scientific FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) is substantially equivalent in design and intended use to the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984.

5.3 Device Description

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· A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow.
· An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion.
· An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated.
· A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

5.4 Intended Use

ર્સ્ડ Summary of Technological Characteristics

The Filter Wire EZ Embolic Protection System (2.25 mm - 3.5 mm) indicated for use in saphenous vein bypass grafts is equivalent to the Filter Wire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984 in that the intended use, principles of operation, design and materials are similar. The following design attributes are the same or similar for the subject device and the predicate device:

Design Attributes

Single Operator Exchange delivery systems Filter-based technology Nitinol® filter/basket component Bionate™ polyurethane filter membrane

"The FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) is an extension of the FilterWire EZ Embolic Protection System family (sizes 3.5 mm - 5.5 mm) cleared under K032884 and K052880; the indications for use in the combined directions for use (for the FilterWire EZ family) will reference the entire vessel diameter range of 2.25 mm to 5.5 mm.

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Compatibility with .014 in. guide wires Compatibility with 6F guide catheters Available in 2 wire lengths; 190 cm and 300 cm Radiopaque guide wire tips Radiopaque markers on filter loop

Non-Clinical Performance Data ર્સ્ડ

Where appropriate, testing conformed to the requirements of 21 CFR Part 58, Good Laboratory Practices (GLP). Specifically, non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use.

5.7 Statement of Substantial Equivalence

Based on a comparison of design, fundamental technology, intended use, results of in-vitro testing, in-vivo testing, biocompatibility, and packaging, Boston Scientific considers the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) to be substantially equivalent to the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) (K051984).

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

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

Re: K061332

Trade/Device Name: FilterWire EZ Embolic Protection System (2.25mm - 3.5mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Distal Embolic Protection Guidewire Regulatory Class: Class II Product Code: NFA Dated: August 4, 2006 Received: August 4, 2006

Dear Ms. McIntire:

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. Debbie McIntire

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dr is lossants over device complies with other requirements of the Act that i DA has made a develations administered by other Federal agencies. You must bir any I cuttlar statures und regulations and limited to: registration and listing (21 Comply with an the 11ct 821 CFR Part 801); good manufacturing practice requirements as set CI K ratt 607); adoning (21 CFR Part 820); and if applicable, the electronic forth in the quant) by events (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section (Section of the as described in your Section 510(k) This letter will and will your of substantial equivalence of your device to a legally premailer notificated. " ceresults 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 n you don't e ffice of Compliance at (240) 276-0120. 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 other general mional and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Special 510(k): Device Modification FilterWire EZ™ Embolic Protection System (2.25 mm - 3.5 mm)

Section 3

Indications For Use

FilterWire EZ™ Embolic Protection System Device Name:

Indications for Use:

The indications for use for the FilterWire EZ Embolic Protection System are as follows:

Prescription Use	X
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (Per 21 CFR 807 Subpart C)

(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	K061332

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).