← Product Code [NFA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA) · K051179 # EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 (K051179) _Boston Scientific Corp · NFA · Jun 8, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K051179 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [NFA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA.md) - **Decision Date:** Jun 8, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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](/device/K032884.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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
and Address | Boston Scientific Corporation
2011 Stierlin Court
Mountain View, CA 94043-4655, U.S.A. | |---------------------------------|----------------------------------------------------------------------------------------------------| | Contact Person | Catherine A. Peters
Regulatory Affairs Specialist
Tel: (650) 623-1755
Fax: (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 Corporation
2011 Stierlin Court
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. {1}------------------------------------------------ #### 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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) Kuma leclere ision Sign-Off) of Cardiovascular Devices 3-1 umber k05 1174 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K051179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NFA/K051179) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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