(29 days)
Not Found
No
The summary describes a mechanical embolic filter system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to protect against emboli during angioplasty and stenting procedures, which is a therapeutic intervention.
No
Explanation: This device is an embolic filter system used for protection during procedures, not for diagnosing conditions. Its function is to prevent emboli from traveling downstream, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it consists of a physical device, delivery catheter, and retrieval catheter, indicating it is a hardware-based medical device.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The GORE® Embolic Filter system is a physical device used during a medical procedure (angioplasty and stenting) to capture emboli (blockages) in the carotid arteries. It is a therapeutic and protective device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states its purpose is for "general use as a guidewire and embolic protection system during angioplasty and stenting procedures." This is a procedural function, not a diagnostic one.
- Device Description: The description details the physical components and their role in the procedure, not any analytical or testing capabilities.
- Performance Studies: The performance studies focus on the device's physical properties, biocompatibility, and performance during the procedure (loading, deployment, retrieval, filter efficiency), not on the accuracy of any diagnostic test results.
Therefore, based on the provided information, the GORE® Embolic Filter system is a medical device used in a therapeutic procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
Product codes
NTE
Device Description
The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm. This Special 510(k) provides for the use of CBAS® heparin coating on the device.
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
Biocompatibility: Biocompatibility testing of the GORE® Embolic Filter consisted of cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity and hemocompatibility (hemolysis, complement activation, coagulation, in vivo thrombogenesis). Additionally an LAL endotoxin test was conducted on the device.
Non-Clinical: Testing of the GORE® Embolic Filter consisted of biocompatibility, sterilization, packaging, product shelf life and performance testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices and include the following:
System Tests
- Loading, Deployment and Retrieval Forces .
Filter Component Tests - Filter Efficiency .
- Heparin Concentration, Hydrophilicity, Residuals and Elution .
Animal: Animal studies were conducted to evaluate the performance of the CBAS® heparin coating in accordance with 21 CFR 58.
Key Metrics
Not Found
Predicate Device(s)
K103500 GORE® Embolic Filter, K042218 Accunet Embolic Protection System, Abbott
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
GORE® and Design are trademarks of W. L. Gore & Associates, Inc. CBAS® is a registered trademark of Carmeda, AB.
1
510(k) SUMMARY [21 CFR 807.92(a)(1)]
-
- Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use:
The GORE® Embolic Filter is substantially equivalent to the currently marketed devices in intended use, materials, technological characteristics and performance. This Special 510(k) provides for the use of CBAS® heparin coating on the device.
- Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use:
-
- Performance Data / Predicate Device Comparison [807.92(a)(6)]
Biocompatibility: Biocompatibility testing of the GORE® Embolic Filter consisted of cytotoxicity,sensitization, irritation, acute systemic toxicity, pyrogenicity and hemocompatibility (hemolysis, complement activation, coagulation, in vivo thrombogenesis). Additionally an LAL endotoxin test was conducted on the device.
- Performance Data / Predicate Device Comparison [807.92(a)(6)]
Non-Clinical: Testing of the GORE® Embolic Filter consisted of biocompatibility, sterilization, packaging, product shelf life and performance testing. These tests demonstrated that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices and include the following:
System Tests
- Loading, Deployment and Retrieval Forces .
Filter Component Tests
- Filter Efficiency .
- Heparin Concentration, Hydrophilicity, Residuals and Elution .
Animal: Animal studies were conducted to evaluate the performance of the CBAS® heparin coating in accordance with 21 CFR 58.
8. Conclusion
The GORE® Embolic Filter is substantially equivalent to the predicate devices in terms of material composition, design, intended use, and performance attributes.
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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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAR 1 6 2012
W.L. Gore and Associates, Inc. c/o Ms. Michelle Ann Wells, RAC Regulatory Affairs 4250 West Kiltie Lane Flagstaff, AZ 86001
Re: K120480
Trade/Device Name: Gore Embolic Filter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: February 15, 2012 Received: February 16, 2012
Dear Ms. Wells:
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.
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Page 2 - Ms. Michelle Wells
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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W. L. Gore & Associates, Inc. Original 510(k) GORE® Embolic Filter Guidewire and embolic protection system indication
INDICATIONS FOR USE STATEMENT 4
| Indications for Use |
|---|
| ---------------------------- |
510(k) Number (if known):
Device Name:
GORE® Embolic Filter
Indications for Use:
The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovasc 510(k) Numb
GORE® and Design are trademarks of W. L. Gore & Associates, Inc. CBAS® is a registered trademark of Carmeda, AB.