GORE EMBOLIC FILTER

K103500 · W. L. Gore & Associates, Inc. · NTE · May 23, 2011 · Cardiovascular

Device Facts

• Record ID: K103500
• Device Name: GORE EMBOLIC FILTER
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: NTE · Cardiovascular
• Decision Date: May 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

GORE® Embolic Filter system comprises a device, delivery catheter, and retrieval catheter; compatible with guiding catheters/sheaths (min ID 0.066"). Used during carotid artery angioplasty and stenting to capture embolic debris. Operated by physicians in clinical settings. Device functions as a guidewire to cross lesions and as a filter to trap emboli during procedures. Output is physical capture of embolic material, preventing distal embolization. Benefits include reduced risk of stroke or embolic complications during carotid interventions. Performance verified via bench testing (loading/deployment/retrieval forces, radial force, particulate quantification, radiopacity, fatigue) and animal studies in tortuous anatomy.

Clinical Evidence

Gore EMBOLDEN clinical trial: prospective, multicenter, nonrandomized, single-arm study. Enrolled 250 subjects at 35 US sites. Primary endpoint: 30-day safety and efficacy compared to performance goals derived from carotid stent studies using distal embolic protection. Results confirmed the device met performance goals, demonstrating safety and efficacy for carotid artery stenting.

Technological Characteristics

Percutaneous catheter system; includes delivery and retrieval catheters. Features include heparin coating, radiopaque markers, and filter bag geometry. Tested for biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), sterilization, and mechanical performance (radial force, deployment/retrieval forces, pulsatile fatigue).

Indications for Use

Indicated for 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.

Regulatory Classification

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.

Predicate Devices

• SpiderFX Embolic Protection Device (K063204)
• Accunet Embolic Protection System, Abbott (K042218)

Submission Summary (Full Text)

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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.<br>4250 W. Kiltie Lane<br>Flagstaff, AZ 86001 |
|----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michelle Ann Wells, RAC<br>Regulatory Affairs<br>Toll Free: [phone]<br>Facsimile: [phone]<br>[e-mail] |
| Date Prepared: | May 19.2011 |

- 2. 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 .
- 3. Device Predicates [807.92(a)(3)]

K063204 SpiderFX Embolic Protection Device, ev3 K042218 Accunet Embolic Protection System, Abbott

- 4. 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.

- 5. 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.

Image /page/0/Picture/17 description: The image shows a logo with the word "GORE" in bold, italicized letters. Below the word "GORE" is a thin horizontal line, and below that are two lines of smaller text that are difficult to read. To the right of the logo is a large, outlined letter "C".

CONFIDENTIAL

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

- 6. 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.

- 7. 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.

- 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

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 [phone] or [phone] 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:

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)

Bram Jole

(Division Siar Division of C 510(k) Number

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

Image /page/5/Picture/17 description: The image contains a logo and some text. The logo is on the left side of the image and appears to be a stylized design. To the right of the logo, there is some text, but it is not clear enough to read. The image is in black and white.

CONFIDENTIAL