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.

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.

AI/ML Overview

The provided text focuses on the GORE® Embolic Filter's 510(k) summary, which details its substantial equivalence to predicate devices. It describes the device, its intended use, and the performance data used to support its equivalence. However, it does not provide specific quantitative acceptance criteria or a detailed study proving the device meets those criteria in the way a clinical study report would.

The information primarily discusses types of testing performed rather than specific results or predefined acceptance thresholds.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of a table with specific quantitative acceptance criteria and corresponding reported device performance values. The text describes types of tests performed to demonstrate substantial equivalence, but not the specific numerical targets or results of these tests against defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Again, this information is not explicitly provided in the document. The text mentions "Animal: Animal studies were conducted to evaluate the performance of the CBAS® heparin coating," but does not specify the number of animals used or the design of these studies (e.g., retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes non-clinical and animal studies, not a study involving human interpretation or expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not mentioned or indicated. The document focuses on demonstrating substantial equivalence through non-clinical and animal testing, not through human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device is a physical medical device (embolic filter), not an AI algorithm. The performance evaluation is related to its mechanical and biological characteristics.

7. Type of Ground Truth Used

Based on the description of testing, the "ground truth" was established through:

Biocompatibility testing: Standardized laboratory assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility, LAL endotoxin test).
Non-Clinical System Tests: Evaluation of loading, deployment, and retrieval forces.
Filter Component Tests: Evaluation of filter efficiency, heparin concentration, hydrophilicity, residuals, and elution.
Animal Studies: In vivo evaluation of CBAS® heparin coating performance.

Essentially, the ground truth was established by direct measurement and observation in controlled laboratory and animal environments according to established protocols for medical device testing.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

In summary, the provided text describes a 510(k) submission focused on demonstrating substantial equivalence for a physical medical device (GORE® Embolic Filter). The document outlines various types of performance testing (biocompatibility, mechanical, animal studies) but does not provide the quantitative details of acceptance criteria or the specific results of these studies against those criteria, nor does it describe studies involving human readers, AI, or specific statistical evaluations of diagnostic performance.

Summary

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<120480
MAR 1 6 2012

510(k) SUMMARY [21 CFR 807.92(a)(1)]

1. 510(k) Owner's Contact Information: name, address, phone and fax numbers, name of contact person, and date the summary was prepared [807.92(a)(1)]

Applicant:	W. L. Gore & Associates, Inc.4250 W. Kiltie LaneFlagstaff, AZ 86001
Contact:	Michelle Ann Wells, RACRegulatory AffairsToll Free: (800) 437-8181Facsimile: (928) 864-4957mwells@wlgore.com

March 15, 2012

Name of the Device: including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known [807.92(a)(2)]

Trade name GORE® Embolic Filter .
Common name Percutaneous catheter .
Classification name Temporary carotid catheter for embolic capture .
Classification 21CFR 870.1250, NTE Class II .
1. Device Predicates [807.92(a)(3)]

Date Prepared:

K103500 GORE® Embolic Filter K042218 Accunet Embolic Protection System, Abbott

1. Description of the Device [807.92(a)(4)]
  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.
1. Intended Use [807.92(a)(4)]
  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.

GORE® and Design are trademarks of W. L. Gore & Associates, Inc. CBAS® is a registered trademark of Carmeda, AB.

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510(k) SUMMARY [21 CFR 807.92(a)(1)]

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.
1. 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.

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:

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.

Regulation Number and Section

§ 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).