(169 days)
Not Found
No
The summary describes a mechanical embolic protection system and its performance in clinical and non-clinical studies. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
Yes
The device is used to contain and remove embolic material, which is a therapeutic intervention to prevent or mitigate adverse events during angioplasty and stenting procedures.
No
The WIRION™ is an embolic protection system designed to contain and remove embolic material during angioplasty and stenting procedures. It is a therapeutic device that acts to prevent complications, not to diagnose a condition.
No
The device description clearly states it is an "embolic protection System comprised of an independent Filter Unit" and details numerous non-clinical tests related to physical properties and performance of a hardware device (e.g., Embolic Capture Efficiency, Tensile Strength, Fatigue, Radio-opacity). The clinical and animal studies also evaluate the performance and safety of a physical device used in a medical procedure.
Based on the provided information, the WIRION™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the WIRION™ is an "embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries." This describes a device used within the body during a surgical procedure, not a device used to examine specimens outside the body.
- Device Description: The description details a physical system comprised of a filter unit delivered and deployed on a guide wire. This is consistent with an interventional medical device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
The WIRION™ is an interventional medical device designed for use during a surgical procedure to protect against embolization.
N/A
Intended Use / Indications for Use
The WIRIONTM is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRIONTM may be used with commercially available 0.014" guide wires.
Product codes
NTE
Device Description
WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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)
Clinical and non-clinical tests were conducted. The appropriate tests performed in order to determine substantial equivalency were completed.
These include testing in accordance with FDA Guidance for coronary and carotid embolic protection devices - premarket notification submissions (February 15, 2008) and additional tests as determined during WIRION™s V&V activities. All tests met their predetermined acceptance criteria and the device was found substantially equivalent to the predicate devices for its intended use.
Non-clinical Data: The following tests have been performed:
- a) Embolic Capture Efficiency and Retrieval Ability
- b) Stent Compatibility
- c) Simulated Use
- d) Resistance to filter rupture during removal of a fully loaded filter
- e) Flow Characteristics
- f) Radial Outward Force
- g) Tip Flexibility
- h) Tensile Strength
- Torque Strength and Response i)
- j) Dimensional Verification
- k) Catheter Coating Integrity
- I) Corrosion Resistance
- m) Fatigue
- n) Radio-opacity
- o) EtO Sterilization Validation for at least SAL 10-6.
- p) Shelf Life/Package Integrity Tests
- q) Biocompatibility according to ISO 10993-1:2009 and FDA Blue Book Memorandum, G95-1.
Animal Data: Two animal studies were conducted using swine model. Safety parameters such as vessel injury, thrombus formation, neurological effects, device integrity and hemolysis were evaluated. Performance parameters including usability, navigation, delivery, placement and retrieval of the system and the ability to capture embolic particles were evaluated as well. The device performed comparably to the predicate device. The animal studies results support the substantial equivalence of the WIRION EPS.
Clinical Data: Clinical data from the WIRION™ was collected from clinical studies and commercial use.
Open label single arm feasibility study aimed at demonstrating the safety and performances of the device used during treatment of carotid artery lesions undergoing stenting was conducted.
The WISE study: Multicenter non-randomized prospective, open label, single arm study with comparison to historic control was conducted on 120 patients.
The primary endpoint was MACCE rate and the secondary endpoint evaluated the device performances.
The data demonstrated that the observed MACCE rate was 3.3% while the MACCE rate of the historic control was 6.3%. The obtained P value was 0.0008, less than the 0.0015 which is the performance goal of the study thus the WIRION system met the primary end point.
Secondary endpoint (performances) included device success, clinical success, access site complications, angiographic and procedural success rate. All functions had high success rate of more than 95%. The endpoints related to incidents and complications, were low resulting in 1.7% and 4.1% as summarized below: Device success: 99.2%; Clinical success: 97.5%; Angiographic success: 99.2%; Procedural success: 98.3%; Access site complications: 1.7%; Neurological events: 4.1%. The device performed well and met all specifications and intended use requirements therefore secondary endpoint was met as well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MACCE rate: 3.3% (observed) vs. 6.3% (historic control)
P value: 0.0008
Device success: 99.2%
Clinical success: 97.5%
Angiographic success: 99.2%
Procedural success: 98.3%
Access site complications: 1.7%
Neurological events: 4.1%
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Gardia Medical Ltd. Ohad Haas VP Quality Assurance & Regulatory Affairs 2 Ha-Eshel Street, PO Box 3081 Caesarea Industrial Park 38900, Israel
Re: K143570
Trade/Device Name: WIRION Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: May 7, 2015 Received: May 11, 2015
Dear Ohad Haas:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name WIRIONTM
Indications for Use (Describe)
The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Gardia Medical. The logo features the word "GARDIA" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. Above the text is an abstract graphic element composed of two overlapping shapes. The top shape is a light blue, semi-circular pattern of dots, while the bottom shape is a red, triangular shape also composed of dots.
TRADITIONAL 510(K) SUMMARY WIRION™ Embolic Protection System
| Date of summary: | June 1, 2015 |
|---|---|
| 510(k) Number: | K143570 |
| Applicant's Name: | Gardia Medical Ltd. |
| 2 Ha-Eshel St. P.O. Box 3081 | |
| Caesarea Industrial Park 38900, Israel | |
| Tel.: +972-4-6277166, Ext. 107 | |
| Fax: +972-4-6277266 | |
| Contact Person: | Ohad Haas |
| VP QA & RA | |
| Phone: (972) 4-6277166, Ext. 303 | |
| Fax: (972) -4-6277266 | |
| ohadh@gradiamedical.com | |
| Trade Name: | WIRION™ |
| Common name: | Embolic Protection System |
| Classification: | Name: Embolic Protection System |
| Description: Cardiovascular Percutaneous catheter | |
| Product Code: NTE | |
| Regulation Number: 870.1250 | |
| Class: II | |
| Classification Panel: Cardiovascular Percutaneous catheter | |
| Predicate Devices: | Substantial equivalence to the following predicates is claimed: |
- FilterWire EZ™ Embolic Protection System; Boston
Scientific, cleared under 510(k) number K063313. - AngioGuard RX Emboli Capture Guide wire System
Cordis Corporation, a Johnson & Johnson Company
cleared under 510(k) number K101651. |
Device Description:
WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.
4
Image /page/4/Picture/0 description: The image shows the logo for Gardia Medical. The logo features the company name in blue, with "GARDIA" in a larger, bolder font above "MEDICAL" in a smaller font. Above the text is a graphic element composed of two overlapping shapes made of small circles. The shape on the left is blue, and the shape on the right is red.
Indication for Use Statement:
The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.
Technological characteristics and Substantial Equivalence:
A comparison between the WIRION™ Embolic Protection System and its predicates was performed in order to support substantial equivalence determination.
The substantial equivalency was concluded based on the device's intended use, system components, functional characteristics, principle of operation, technological characteristics, sterilization, materials and biocompatibility.
The conclusion of the comparison analysis is that the WIRION™ Embolic Protection System is Substantially Equivalent to the predicate devices.
Performance Testing:
Clinical and non-clinical tests were conducted. The appropriate tests performed in order to determine substantial equivalency were completed.
These include testing in accordance with FDA Guidance for coronary and carotid embolic protection devices - premarket notification submissions (February 15, 2008) and additional tests as determined during WIRION™s V&V activities. All tests met their predetermined acceptance criteria and the device was found substantially equivalent to the predicate devices for its intended use.
Non-clinical Data:
The following tests have been performed:
- a) Embolic Capture Efficiency and Retrieval Ability
- b) Stent Compatibility
- c) Simulated Use
- d) Resistance to filter rupture during removal of a fully loaded filter
- e) Flow Characteristics
- f) Radial Outward Force
- g) Tip Flexibility
- h) Tensile Strength
- Torque Strength and Response i)
- j) Dimensional Verification
- k) Catheter Coating Integrity
- I) Corrosion Resistance
- m) Fatigue
- n) Radio-opacity
- o) EtO Sterilization Validation for at least SAL 10-6.
5
Image /page/5/Picture/0 description: The image shows the logo for Gardia Medical. The logo features a stylized graphic element above the company name. The graphic element is composed of two overlapping shapes: a blue, semi-transparent shape on the left and a red shape on the right, both with a dotted pattern. Below the graphic, the word "GARDIA" is written in a bold, blue sans-serif font, and below that, the word "MEDICAL" is written in a smaller, lighter blue font.
- p) Shelf Life/Package Integrity Tests
- q) Biocompatibility according to ISO 10993-1:2009 and FDA Blue Book Memorandum, G95-1.
Animal Data:
Two animal studies were conducted using swine model.
Safety parameters such as vessel injury, thrombus formation, neurological effects, device integrity and hemolysis were evaluated.
Performance parameters including usability, navigation, delivery, placement and retrieval of the system and the ability to capture embolic particles were evaluated as well. The device performed comparably to the predicate device. The animal studies results support the substantial equivalence of the WIRION EPS.
Clinical Data
Clinical data from the WIRION™ was collected from clinical studies and commercial use.
Open label single arm feasibility study aimed at demonstrating the safety and performances of the device used during treatment of carotid artery lesions undergoing stenting was conducted.
The WISE study: Multicenter non-randomized prospective, open label, single arm study with comparison to historic control was conducted on 120 patients.
The primary endpoint was MACCE rate and the secondary endpoint evaluated the device performances.
The data demonstrated that the observed MACCE rate was 3.3% while the MACCE rate of the historic control was 6.3%. The obtained P value was 0.0008, less than the 0.0015 which is the performance goal of the study thus the WIRION system met the primary end point.
Secondary endpoint (performances) included device success, clinical success, access site complications, angiographic and procedural success rate. All functions had high success rate of more than 95%. The endpoints related to incidents and complications, were low resulting in 1.7% and 4.1% as summarized below: Device success: 99.2%; Clinical success: 97.5%; Angiographic success: 99.2%; Procedural success: 98.3%; Access site complications: 1.7%; Neurological events: 4.1%. The device performed well and met all specifications and intended use requirements therefore secondary endpoint was met as well.
Conclusions:
The evaluation of the WIRION™ Embolic Protection System performance tests and biocompatibility studies demonstrated that the device performs as intended and that it is as safe and as effective as the predicate devices.
In light of the above, we believe it is substantially equivalent to the FilterWire EZ™ Embolic Protection System (K063313) and to the AngioGuard RX Emboli Capture Guidewire System (K101651) and that it is appropriate for its intended use.