(30 days)
Not Found
No
The description focuses on the mechanical function and physical characteristics of a retrieval sheath used with an embolic protection system. There is no mention of AI, ML, or any computational analysis of data for decision-making or image processing.
No
The device is described as an accessory component used for retrieving another device (FilterWire EZ protection wire), not for treating a disease or condition itself.
No
The document states the device is used for the retrieval and/or redeployment of another medical device (FilterWire EZ device) and mentions its use for navigating anatomy with fluoroscopic visualization. It does not describe any function related to diagnosing a disease, condition, or physiological state.
No
The device description clearly describes a physical medical device (sheath with a retractable tip) used in conjunction with another physical medical device (FilterWire EZ Embolic Protection System). It mentions physical characteristics like a retractable tip, marker band, and visualization under fluoroscopic imaging, all indicative of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body to retrieve or redeploy another medical device (the FilterWire EZ). This is an in vivo procedure, not an in vitro diagnostic test.
- Device Description: The description details a physical sheath with a retractable tip designed for navigating blood vessels and interacting with another device inside the patient. This is consistent with an interventional medical device, not a diagnostic test performed on samples outside the body.
- Input Imaging Modality: Fluoroscopic imaging is used to visualize the device inside the patient during the procedure. This is typical for interventional devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition based on such analysis.
In summary, the EZ Plus Retrieval Sheath is an accessory component of an embolic protection system used in interventional procedures within the body, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
NFA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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