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.

AI/ML Overview

Acceptance Criteria and Study Details for GORE® Embolic Filter

This document describes the acceptance criteria and supporting study for the GORE® Embolic Filter, based on the provided 510(k) summary.

Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a full-scale clinical trial with specific performance goals for de novo approval. Therefore, the "acceptance criteria" here are framed around successful demonstration against a performance goal derived from existing carotid stent studies using embolic protection, rather than absolute, pre-defined numerical thresholds for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal Derived from Predicates)	Reported Device Performance (Gore EMBOLDEN Clinical Trial)
Safety and efficacy comparable to or better than performance goal obtained from carotid stent studies utilizing distal embolic protection.	Statistical analysis confirms that the GORE® Embolic Filter met the performance goal defined for the study.

Explanation of "Acceptance Criteria" in this Context:
For a 510(k) submission, the "acceptance criteria" for clinical performance are typically relative to predicate devices or established performance goals. Here, the device aimed to demonstrate safety and efficacy that was non-inferior (or superior) to a performance goal established from a meta-analysis or pooled data of previously approved carotid stent studies that also used distal embolic protection. The specific numerical targets for safety and efficacy endpoints (e.g., stroke rates, major adverse cardiac and cerebrovascular events (MACCE)) that comprised this "performance goal" are not explicitly detailed in the summary but are implied to have been defined prior to the study.

2. Sample Size and Data Provenance

Test Set Sample Size: 250 pivotal subjects.
Data Provenance: Prospective, multicenter, nonrandomized, single-arm study conducted across Thirty five (35) US sites.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not explicitly state the number of experts used to establish ground truth for the test set from a diagnostic or image interpretation perspective. As this is an embolic filter, the "ground truth" would primarily be clinical outcomes (e.g., incidence of stroke, periprocedural complications) rather than a specific diagnostic interpretation. Therefore, the "experts" would be the clinical investigators and study personnel responsible for assessing patient outcomes. Their qualifications are implicitly assumed to be appropriate for conducting clinical trials involving carotid artery stenting procedures.

4. Adjudication Method for the Test Set

The summary does not explicitly detail an adjudication method (e.g., 2+1, 3+1). For clinical trials evaluating safety and efficacy, particularly for events like stroke or other adverse events, an independent Clinical Events Committee (CEC) is typically employed to adjudicate reported events according to pre-defined criteria. While not explicitly mentioned, this is a standard practice for trials of this nature.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI devices where human readers interpret images. The GORE® Embolic Filter is a medical device for embolic protection during a procedure, and its performance is assessed through clinical outcomes rather than diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device, not an AI algorithm. Its performance is intrinsically linked to its use by medical professionals in a clinical setting ("human-in-the-loop").

7. Type of Ground Truth Used

The ground truth used for the clinical study was primarily outcomes data. This includes:

30-day safety outcomes (e.g., stroke, death, myocardial infarction related to the procedure).
30-day efficacy outcomes (implied to be successful delivery and protection, potentially assessed by freedom from periprocedural stroke or TIA).

These outcomes are collected and assessed from the actual patients in the study.

8. Sample Size for the Training Set

This question is not applicable in the context of this device. The GORE® Embolic Filter is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The "training" for such devices typically refers to pre-clinical testing, design iterations, and eventually, the clinical trial (which acts as a validation/confirmation step rather than iterative training).

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

This question is not applicable for the reasons stated above. As there is no AI/ML training set, there is no corresponding method for establishing a ground truth for a training set. The "ground truth" during the development phase would relate to engineering specifications and performance in bench and animal testing. These were mentioned as "Non-Clinical" and "Animal" studies, respectively, covering aspects like loading, deployment, retrieval, quantification of particulate, filter efficiency, and vessel damage.

Summary

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103500 MAY 2 3 2011

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
Date Prepared:	May 19.2011

1. 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)]

K063204 SpiderFX Embolic Protection Device, ev3 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.
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.

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CONFIDENTIAL

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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.
1. Performance Data / Predicate Device Comparison [807.92(a)(6)]
  Biocompatibility: Biocompatibility testing of the GORE® Embolic Filter consisted of cytotoxicity, endotoxin, heavy metals, sensitization, irritation, acute systemic toxicity (systemic injection and material mediated), and hemocompatibility (indirect contact and complement activation).

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 .
Deployment Reliability ●
Radial Force .
Quantification of Particulate .
Deployment Cycles .
Track Force .
Dimensional Verification .
Radiopacity Evaluation ●
. Critical Landing Zone
Lesion Crossing Capability and Force .
. Stent Compatibility
Deployment Force in Tortuous Anatomies .

Guidewire Component Tests

. Tip Flexibility
Tensile .
Torque Response ●
Torque Strength .
Dimensional .

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

Filter Component Tests

Tensile .
Filter Bag Volume .
Filter Efficiency .
Heparin Concentration, Hydrophilicity, Residuals and Elution .
Filter Bag/Pore Size Spacing and Geometry .
Pulsatile Fatique .
Delivery and Retrieval Catheter Component Testing .
Tensile (Delivery and Retrieval) .
Compressive (Delivery and Retrieval) .
Dimensional (Delivery and Retrieval) .

Animal: Animal studies were conducted to evaluate the performance, ease of use, handling characteristics, and vessel damage in tortuous anatomy in accordance with 21 CFR 58.

Clinical: The Gore EMBOLDEN Clinical Trial was a prospective, multicenter, nonrandomized, single-arm study designed to compare 30-day safety and efficacy of the GORE® Embolic Filter System used with FDA approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection. Thirty five (35) US sites enrolled 250 pivotal subjects. Statistical analysis confirms that the GORE® Embolic Filter met the performance goal defined for the study, demonstrating the safety and efficacy of the GORE® Embolic Filter for use in carotid artery stenting when used in accordance with the Instructions for Use.

1. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

W.L. Gore & Associates, Inc. c/o Ms. Michelle Wells 4250 W. Kiltie Lane Flagstaff, AZ 86001

MAY 2 3 2011

Re: K103500

Trade/Device Name: GORE Embolic Filter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: May 17, 2011 Received: May 18, 2011

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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):

K 103500

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)

Bram Jole

(Division Siar Division of C 510(k) Number

GORE® and Design are trademarks of W. L. Gore & Associates, Inc.

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CONFIDENTIAL

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).