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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

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

Device Description

The Boston Scientific FilterWire EZ System (3.5 mm - 5.5 mm) 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, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath is also 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 overthe-wire catheter exchanges.

The FilterWire EZ System is delivered via the EZ Delivery Sheath. Once the Protection Wire is across the lesion, the filter bag is expanded in the artery lumen by removing the EZ Delivery Sheath. After treating the lesion, all interventional devices are removed, and the EZ Soft Tip Retrieval Sheath or EZ Bent Tip Retrieval Sheath is advanced to the proximal end of the filter and the filter loop is retracted into the EZ Retrieval Sheath, trapping any emboli caught during the procedure. The EZ Retrieval Sheath and Protection Wire are then removed from the patient simultaneously.

AI/ML Overview

This document describes the Boston Scientific FilterWire EZ™ Embolic Protection System.

Acceptance Criteria and Device Performance

Due to the nature of the device (a physical medical device for embolic protection), the provided 510(k) summary does not contain specific quantitative acceptance criteria or detailed device performance metrics in the format of a typical AI/software device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical trial.

Summary of Device Performance and Verification:

Category	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Testing	Met all applicable product specifications	Successfully conducted and met specifications
Tensile/Torque Testing	Met all applicable product specifications	Successfully conducted and met specifications
Functional Testing (in-vitro)	Met all applicable product specifications	Successfully conducted and met specifications
Biocompatibility	Demonstrated biocompatibility	Successfully conducted and met requirements
Packaging Testing	Maintained integrity and sterility	Successfully conducted and met requirements
Product Shelf Life Testing	Demonstrated stability over shelf life	Successfully conducted and met requirements
Functional Testing (animal models)	Demonstrated intended function and safety	Successfully conducted and met requirements
Clinical Performance (CABERNET Trial)	Demonstrated safety and effectiveness in carotid artery stenting	Results presented in the FilterWire EZ System Directions for Use (DFU), used to support NexStent PMA (P050025)

Note on Quantitative Data: The provided text does not offer numerical percentages, sensitivities, specificities, or other quantitative performance data often associated with acceptance criteria for AI/software devices. The "acceptance criteria" for this physical device are implicitly met by passing various engineering, biological, and clinical studies to demonstrate substantial equivalence to legally marketed predicate devices.

Study Information

The primary clinical evidence referenced is the CABERNET Trial.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in this 510(k) summary. The document mentions the CABERNET Trial's results were used to support the NexStent PMA (P050025). To obtain the exact sample size, one would need to refer to the PMA for the NexStent Carotid Stent.
- Data Provenance: The study was a "carotid artery stenting clinical trial (CABERNET) sponsored by EndoTex™ Interventional Systems, Inc." This indicates it was a prospective clinical trial, likely involving multiple sites (though not explicitly stated) and would have predominantly included data from the country/countries where the trial was conducted. The specific country of origin is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. For a clinical trial of a physical device, "ground truth" would typically be established through clinical outcomes, imaging assessments adjudicated by a clinical events committee (CEC), or other objective medical findings, rather than expert consensus on interpretive data (as would be common for AI/diagnostic software).
Adjudication method for the test set:
- This information is not explicitly stated in the 510(k) summary. Clinical trials often employ a Clinical Events Committee (CEC) for endpoint adjudication, where multiple experts review cases. However, the specific method (e.g., 2+1, 3+1) is not detailed here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolic protection system), not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or software requiring a standalone performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a clinical trial evaluating the safety and effectiveness of an embolic protection system, the "ground truth" would primarily be clinical outcomes data, such as rates of stroke, death, myocardial infarction, and other adverse events, as well as procedural success and device-related complications. Imaging data (e.g., degree of revascularization, evidence of embolization) would also contribute.
The sample size for the training set:
- Not applicable. This device is a physical medical device undergoing a clinical trial for safety and effectiveness, not a machine learning model that requires a training set. The "in-vitro testing," "in-vivo testing," and "clinical evaluation" serve to validate the physical device.
How the ground truth for the training set was established:
- Not applicable. As a physical device, there is no "training set" in the context of machine learning.

Summary

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JEC - 5 2006

510(k) Summary

Submitter's Name:	Boston Scientific Corporation
Submitter's Address:	2011 Stierlin CourtMountain View, CA 94043-4655
Contact Person:	Donna PageManager, Regulatory Affairs, Carotid Programs(650) 623-1708(650) 623-1790 FAXpaged1@bsci.com
Device Proprietary Name:	FilterWire EZ™ Embolic Protection System(3.5 mm - 5.5 mm)
Device Common Name:	Embolic Protection Device
Device Classification Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code NTE)
Device Class:	Class II
Date Prepared:	November 30, 2006

(This Summary is submitted in accordance with 21 CFR Part 807, Section 807.92)

Identification of Predicate Device:

The Boston Scientific FilterWire EZ" Embolic Protection System (FilterWire EZ System) is substantially equivalent in design and intended use (embolic protection) to the same devices legally marketed under K032884 (3.5 mm to 5.5 mm) and K061332 (2.25 mm to 3.5 mm) for use in saphenous vein bypass grafts. The FilterWire EZ System is also substantially equivalent in design and indications for use to the RX ACCUNET" Embolic Protection System (K042218) legally marketed as an embolic protection device for use in the carotid vasculature.

Device Description:

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with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for overthe-wire catheter exchanges.

Indications for Use:

The FilterWire EZ™ Embolic Protcction 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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

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

Summary of Technological Characteristics:

The FilterWire EZ System (3.5 mm to 5.5 mm) indicated for use in the carotid vasculature is the same device indicated for use in saphenous vein bypass grafts. The design, principles of operation and materials are identical to the predicate FilterWire EZ System cleared under K032884. The FilterWire EZ System is also equivalent in design and indications to the RX ACCUNET Embolic Protection System cleared under K042218. The following design attributes are the same or similar for the subject device and the identified predicate devices:

. Rapid Exchange (RX) delivery systems
. Filter based technology
Nitino1® filter/basket component .
Polyurethane filter membrane .
. Compatibility with .014" guide wires
Compatibility with 6F guide catheters ●
. Available in 190 and/or 300 cm lengths
Accommodates similar vessel sizes .
Radiopaque guide wire tips and/or delivery sheath tips
� Radiopaque markers on filter loop

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Performance Data:

Filter Wire EZ System in-vitro testing consisted of dimensional testing, tensile/torque testing and functional testing. Biocompatibility, packaging testing, product shelf life testing and functional testing in animal models have also been successfully conducted. Test results verified that the FilterWire EZ System met all applicable product specifications for its intended use.

The clinical performance of the FilterWire EZ System (3.5 mm - 5.5 mm) was evaluated in conjunction with the NexStent" Carotid Stent (NexStent) in a carotid artery stenting clinical trial (CABERNET) sponsored by EndoTex " Interventional Systems, Inc. The results of the CABERNET Trial were used in support of the NexStent PMA, P050025.

Results of the CABERNET Trial are presented in the FilterWire EZ System Directions for Use (DFU).

Statement of Substantial Equivalence:

Boston Scientific Corporation considers the Filter Wire EZ System substantially equivalent to the FilterWire EZ System legally marketed by Boston Scientific Corporation and to the Guidant RX ACCUNET Embolic Protection System based on a comparison of intended use and the results of in-vitro testing, in-vivo testing, and clinical evaluation.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2006

Boston Scientific Corporation c/o Ms. Donna Page Manager, Regulatory Affairs, Carotid Programs 2011 Stierlin Court Mountain View, CA 94043-4655

Re: K063313

Boston Scientific FilterWire EZTM Embolic Protection System (3.5 mm - 5.5 mm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: November 1, 2006 Received: November 2, 2006

Dear Ms. Page:

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. Donna Page

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 (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 Manufacturers, International 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,

Duma 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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510(k) Number (if known) 4063313

Device Name: FilterWire EZ™ Embolic Protection System

Indications for Use:

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 and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

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)

Duna R. bachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K063313

510(k) Amendment – K063313/AI
FilterWire EZ™ Embolic Protection System

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).