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.

Device Description

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.

AI/ML Overview

The provided text refers to a Special 510(k) submission for a device modification, specifically the "EZ Plus Retrieval Sheath" which is an accessory to the "FilterWire EZ Embolic Protection System." This document outlines regulatory information and device description, but it does not contain the typical information about clinical studies, acceptance criteria for device performance, or details regarding ground truth establishment that would be found in a comprehensive clinical study report.

The section titled "5.6 Non-Clinical Test Summary" explicitly states: "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."

This indicates that the device's performance was evaluated through non-clinical testing (e.g., bench testing, mechanical testing) rather than human clinical trials or AI performance evaluations. Therefore, I cannot provide details for most of the requested categories.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "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." However, specific acceptance criteria and their corresponding reported performance values are not detailed in this document. It's a high-level summary indicating successful completion of relevant non-clinical testing.

Acceptance Criteria	Reported Device Performance
Not specified	Met design-input criteria; safe and effective for intended use (based on non-clinical testing)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes non-clinical (laboratory/bench) testing, not a clinical study involving human patients or data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no mention of a test set requiring expert-established ground truth. The evaluation was based on non-clinical engineering and performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no mention of a test set with human assessments requiring adjudication.

5. 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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. This device is a physical medical device (retrieval sheath), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical retrieval sheath, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable as the document describes non-clinical testing, which would rely on engineering specifications, material properties, and functional performance benchmarks rather than clinical ground truth types.

8. The sample size for the training set

This is not applicable as this describes a physical medical device and not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as this describes a physical medical device and not an AI algorithm that requires a training set with ground truth.

Summary

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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 Nameand Address	Boston Scientific Corporation2011 Stierlin CourtMountain View, CA 94043-4655, U.S.A.
Contact Person	Catherine A. PetersRegulatory Affairs SpecialistTel: (650) 623-1755Fax: (650) 623-1610
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 Corporation2011 Stierlin CourtMountain 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

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5.4 Intended Use

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with intertwined snakes.

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 (800) 638-2041 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:

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)

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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of Cardiovascular Devices

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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).