(215 days)
Not Found
No
The device description and performance studies focus on mechanical filtration and guidewire function, with no mention of AI or ML technologies.
Yes
The device is designed to contain and remove embolic material during coronary angioplasty or stenting, which is a therapeutic intervention aimed at treating medical conditions.
No
This device is designed to contain and remove embolic material during a medical procedure, functioning as a protection system rather than a tool for diagnosis. While it prevents complications, it does not analyze or interpret patient data to identify a condition or disease.
No
The device description clearly outlines physical components like a guidewire, delivery sheath, and retrieval sheath, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FilterWire EX Embolic Protection System is a physical device used within the body during a medical procedure (percutaneous transluminal coronary angioplasty or stenting). Its purpose is to capture and remove embolic material in vivo, not to analyze samples in vitro.
- Intended Use: The intended use clearly describes a procedural device for use within the coronary vasculature.
- Device Description: The description details a guidewire filtration system placed distal to the vessel lesion.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, the FilterWire EX Embolic Protection System is a therapeutic and procedural medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FilterWire EX Embolic Protection System is indicated for use as a guidewire and embolic protection system in containing and removing embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
Product codes
NFA
Device Description
The Boston Scientific FilterWire EX™ Embolic Protection System is a temporary intra-vascular 0.014" guidewire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EX Delivery Sheath, an EX Soft Tip Retrieval Sheath and accessories. A separately packaged EX Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire protection wire. When deployed, the protection wire's filter bag is designed to capture and recover emboli that may be produced during the angioplasty/stenting procedure while allowing blood flow to continue. Once deployed, the protection wire is used as a standard 0.014" steerable guidewire.
The EX Delivery Sheath has a radiopaque marker at the tip for visualization of the system under fluoroscopic imaging. The tip of the protection wire and the filter loop are radiopaque. At the completion of the procedure, the filter is resheathed and then removed from the patient using one of two available retrieval sheaths. The 190 cm wire is compatible with the Boston Scientific Trooper Patriot™ Extension Wire for over-the-wire catheter exchanges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
coronary saphenous vein bypass grafts
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
Clinical evaluation was conducted in a randomized clinical trial involving a total of 864 saphenous vein graft subjects. The Filter Wire EX Embolic Protection System was evaluated in a trial cohort of 110 patients versus a 103 patient control population with no embolic protection provided. Thirty (30) day rates of major adverse cardiac events (MACE) including death, myocardial infarction, emergent coronary artery bypass grafting or repeat target vessel revascularization demonstrated a 7.3% rate for the FilterWire EX versus a 7.8% rate for no protection (not significant).
A second trial cohort consisting of 332 patients (FilterWire EX) and 319 patients (commercially available Medtronic® AVE PercuSurge GuardWire Plus® Temporary Occlusion and Aspiration System) demonstrated 30 day MACE rates of 9.9% (FilterWire EX) and 11.6% (GuardWire Plus). It was concluded that the cumulative 30-day MACE rate for the FilterWire EX Embolic Protection System (9.9%) compared to the cumulative 30-day MACE rate for the Medtronic® AVE PercuSurge GuardWire Plus® Temporary Occlusion and Aspiration System (11.6%) was significantly equivalent when tested to a delta of 5.5% (p = 0.0016). The upper 95% confidence interval of the difference between the two groups was 3.1% (95% C.I., -6.4%, 3.1%).
Key Metrics
30 day MACE rates of 9.9% (FilterWire EX) and 11.6% (GuardWire Plus).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions
| Submitter's Name
and Address | Boston Scientific Corporation
2525 Walsh Avenue
Santa Clara, California 95051-1316 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person | Timothy J. Johnson
Director of Regulatory Affairs
(408) 970-7343 |
| Classification Name | Device, Coronary Saphenous Vein Bypass
Graft, Temporary, For Embolization
Protection |
| Common or Usual Name | Embolic Protection Guidewire |
| Proprietary Name | Boston Scientific FilterWire EXT™ Embolic
Protection System |
| Manufacturing Facilities | Boston Scientific Corporation
2525 Walsh Avenue
Santa Clara, California 95051-1316 |
| Name of Predicate Device | Medtronic® AVE PercuSurge GuardWire
Plus® Temporary Occlusion and Aspiration
System (K003992, K014223) |
Device Description
The Boston Scientific FilterWire EX™ Embolic Protection System is a temporary intra-vascular 0.014" guidewire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EX Delivery Sheath, an EX Soft Tip Retrieval Sheath and accessories. A separately packaged EX Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire protection wire. When deployed, the protection wire's filter bag is designed to capture and recover emboli that may be produced during the angioplasty/stenting procedure while allowing blood flow to continue. Once deployed, the protection wire is used as a standard 0.014" steerable guidewire.
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The EX Delivery Sheath has a radiopaque marker at the tip for visualization of the system under fluoroscopic imaging. The tip of the protection wire and the filter loop are radiopaque. At the completion of the procedure, the filter is resheathed and then removed from the patient using one of two available retrieval sheaths. The 190 cm wire is compatible with the Boston Scientific Trooper Patriot™ Extension Wire for over-the-wire catheter exchanges.
Intended Use
The FilterWire EX Embolic Protection System is indicated for use as a guidewire and embolic protection system in containing and removing embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
Summary of Technological Characteristics
The FilterWire EX Embolic Protection System incorporates a filter membrane on a Nitinol loop located approximately six (6) cm proximal to the 0.014 inch diameter guidewire's distal tip. The guidewire (protection wire) is sheathed in a 1.3 mm outer diameter EX Delivery Sheath (an easy exchange sheath). The sheath extends distal to the protection wire's nosecone (just distal to the filter loop/filter assembly). The sheathed FilterWire protection wire, with its radiopaque floppy guidewire tip exposed, is advanced through a guiding catheter (0.065 inch minimum inner diameter) to the saphenous vein graft of choice and across the intended lesion as would a normal coronary guidewire. The protection wire and its floppy tip can be rotated independently of the EX Delivery Sheath because the Filter Wire filter loop assembly is mounted on a spinner tube and the guidewire can rotate under the filter assembly as needed. Once across the target lesion, the loop is deployed by slightly withdrawing the EX Delivery Sheath. The Nitinol loop expands to circumferentially appose the vessel wall. A platinum alloy coil is wound around the Nitinol filter loop to allow fluoroscopic visibility. If the filter loop placement is unsatisfactory, the filter loop can be resheathed and repositioned. If the filter loop placement in the vessel is satisfactory, the EX Delivery Sheath can be completely withdrawn. Once the filter loop expands, blood flows through the polyurethane filter membrane. The filter membrane utilizes laser drilled holes each measuring approximately 110 microns in diameter, to allow blood to flow through while capturing embolic material.
While the Filter Wire is deployed, the stenting and/or angioplasty catheters are threaded over the 0.014" guidewire. During the intervention, the blood flow is monitored angiographically. After the interventional treatment, an EX Soft Tip or Bent Tip Retrieval Sheath is used to cross the treatment site and stents, if deployed, and to retrieve the FilterWire. Advancement of the retrieval sheath over the filter loop causes the filter bag to close, retaining embolic material in the
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filter bag. The assembly is then removed through the vessel and into the guiding catheter.
The device is similar to the predicate device in that it is an interventional means to provide embolic protection for angioplasty/stenting treatments to saphenous vein graft lesions and it provides that embolic protection distal to the target lesion. Both systems are based on 0.014 inch diameter guidewire platforms. The primary difference in technologies involve a filter based technology versus a balloon occlusion method with aspiration.
Non-Clinical and Clinical Test Summary
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 EX Embolic Protection System met all applicable product specifications and is deemed adequate for its intended use.
Clinical evaluation was conducted in a randomized clinical trial involving a total of 864 saphenous vein graft subjects. The Filter Wire EX Embolic Protection System was evaluated in a trial cohort of 110 patients versus a 103 patient control population with no embolic protection provided. Thirty (30) day rates of major adverse cardiac events (MACE) including death, myocardial infarction, emergent coronary artery bypass grafting or repeat target vessel revascularization demonstrated a 7.3% rate for the FilterWire EX versus a 7.8% rate for no protection (not significant).
A second trial cohort consisting of 332 patients (FilterWire EX) and 319 patients (commercially available Medtronic® AVE PercuSurge GuardWire Plus® Temporary Occlusion and Aspiration System) demonstrated 30 day MACE rates of 9.9% (FilterWire EX) and 11.6% (GuardWire Plus). It was concluded that the cumulative 30-day MACE rate for the FilterWire EX Embolic Protection System (9.9%) compared to the cumulative 30-day MACE rate for the Medtronic® AVE PercuSurge GuardWire Plus® Temporary Occlusion and Aspiration System (11.6%) was significantly equivalent when tested to a delta of 5.5% (p = 0.0016). The upper 95% confidence interval of the difference between the two groups was 3.1% (95% C.I., -6.4%, 3.1%).
Boston Scientific Corporation considers the FilterWire EX Embolic Protection System substantially equivalent to the embolic protection guidewire legally marketed by Medtronic AVE based on a comparison of intended use and the results of in-vitro testing, in-vivo testing and clinical evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2003
Mr. Timothy J. Johnson Director of Regulatory Affairs Boston Scientific Corporation/EPI 2525 Walsh Avenue Santa Clara, CA 95051-1316
Re: K023691
Trade/Device Name: FilterWire EXTM Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: NFA Dated: May 29, 2003 Received: May 29, 2003
Dear Mr. Johnson:
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 Féderal 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 -- Mr. Timothy J. Johnson
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html
Sincerely yours,
R. Zeller, M.D.
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 - K023691
FilterWire EXTM Embolic Protection System Device Name:
Indications for Use:
The FilterWire EX Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-the-Counter Use (Per 21 CFR 801.109)
VDelettm
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K027691