GORE(R) EMBOLIC FILTER

K120480 · W.L. Gore & Associates · NTE · Mar 16, 2012 · Cardiovascular

Device Facts

• Record ID: K120480
• Device Name: GORE(R) EMBOLIC FILTER
• Applicant: W.L. Gore & Associates
• Product Code: NTE · Cardiovascular
• Decision Date: Mar 16, 2012
• Decision: SESE
• Submission Type: Special
• 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 filter 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 features CBAS® heparin coating to improve hemocompatibility. System functions as a guidewire and protection filter; captures emboli during procedures to reduce risk of distal embolization. Output is physical capture of embolic material; provider uses device to maintain vessel patency while preventing stroke-related complications from debris migration.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (biocompatibility, sterilization, shelf life, performance testing including filter efficiency and coating characterization) and animal studies evaluating the performance of the CBAS® heparin coating.

Technological Characteristics

Percutaneous catheter system; includes delivery and retrieval catheters. Features CBAS® heparin coating. Materials evaluated for biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility). Performance characteristics include loading, deployment, and retrieval forces, and filter efficiency. Compatible with 0.066" ID guiding catheters/sheaths.

Indications for Use

Indicated for patients undergoing angioplasty and stenting in carotid arteries with reference vessel diameters of 2.5 to 5.5mm, requiring a guidewire and embolic protection system.

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

• GORE® Embolic Filter (K103500)
• Accunet Embolic Protection System, Abbott (K042218)

Submission Summary (Full Text)

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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.<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] |

March 15, 2012

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)]

Date Prepared:

K103500 GORE® Embolic Filter 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. This Special 510(k) provides for the use of CBAS® heparin coating on the device.

- 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. CBAS® is a registered trademark of Carmeda, AB.

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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. This Special 510(k) provides for the use of CBAS® heparin coating on the device.

- 7. 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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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 [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

| <b>Indications for Use</b> |
|----------------------------|
|----------------------------|

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.