GORE FLOW REVERSAL SYSTEM MODEL GFRS073

K123156 · W. L. Gore & Associates, Inc. · NTE · Dec 13, 2012 · Cardiovascular

Device Facts

• Record ID: K123156
• Device Name: GORE FLOW REVERSAL SYSTEM MODEL GFRS073
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: NTE · Cardiovascular
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below: - Adequate iliac/femoral access - Common carotid artery diameters between 6 and 12 mm - External carotid artery diameters less than 6 mm

Device Story

System provides embolic protection during carotid artery angioplasty and stenting. Components include balloon sheath, balloon wire, and external filter. Device reverses blood flow at internal carotid artery treatment site; directs embolic particles away from neurovascular circulation; captures particles in external filter. Used in clinical setting by physicians. Benefits patient by reducing risk of embolic events during stenting procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical evaluations including biocompatibility, sterilization, shelf life, and functional, mechanical, and physical performance testing.

Technological Characteristics

System comprises balloon sheath, balloon wire, and external filter. Materials evaluated for biocompatibility per ISO 10993-1. Mechanical/functional performance testing conducted. No software or electronic components.

Indications for Use

Indicated for patients diagnosed with carotid artery stenosis undergoing carotid artery angioplasty and stenting who possess adequate iliac/femoral access, common carotid artery diameters of 6-12 mm, and external carotid artery diameters < 6 mm.

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® Flow Reversal System (K083300)

Submission Summary (Full Text)

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K12 3156

W. L. Gore & Associates, Inc. Special 510(k) GORE® Flow Reversal System

#### 510(k) SUMMARY [21 CFR 807.92(a)] 5

DEC 1 3 2012 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. 32360 N. North Valley Parkway Phoenix, AZ 85085

Contact:

.

Sharon Alexander Requlatory Affairs Direct: [phone] Fax: [phone] Email: [e-mail]

Date Prepared:

October 3, 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)] 1
- GORE® Flow Reversal System . Trade name:
- Common name: .

Occlusion catheter

- Classification name: Temporary carotid catheter for embolic capture
- Classification: 21 CFR 870.1250, NTE, Class II C
- 3. Device Predicate [807.92(a)(3)]

K083300, GORE® Flow Reversal System

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

The GORE® Flow Reversal System consists of three primary components:

- GORE® Balloon Sheath .
- GORE® Balloon Wire .
- GORE® External Filter .

When assembled together, the GORE® Flow Reversal System reverses the flow of blood at the treatment site of the internal carotid artery (ICA), directing embolic particles away from the neurovascular circulation and removing them through an external filter.

- 5. Intended Use [807.92(a)(4)]
The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients

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

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W. L. Gore & Associates, Inc. Special 510(k) GORE® Flow Reversal System

### 5 510(k) SUMMARY [21 CFR 807.92(a)]

diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:

- . Adequate iliac/femoral access
- Common carotid artery diameters between 6 and 12 mm .
- External carotid artery diameters less than 6 mm .
- 6. Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use:

The modified GORE® Flow Reversal System is substantially equivalent to the currently marketed predicate device in its intended use, technological characteristics and performance.

- 7. Predicate Device Comparison [807,92(a)(6)]
Non-clinical evaluations of the modified GORE® Flow Reversal System included biocompatibility testing in accordance with ISO 10993-1, sterilization, shelf life, and performance testing, including functional, mechanical and physical evaluations. The results of these tests demonstrate that the technological characteristics such as product performance, design, materials and the intended use are substantially equivalent to the currently marketed predicate device.

## 8. Conclusion

The modified GORE® Flow Reversal System is substantially equivalent to the predicate GORE® Flow Reversal System (K083300) in terms of design, material composition, intended use and performance attributes.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures, representing the department's focus on health and human well-being. The text is in bold, sans-serif font.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

DEC 1 3 2012

W.L. Gore & Associates, Inc. c/o Sharon Alexander, Regulatory Affairs Associate Medical Products Division 32360 N North Valley Parkway Phoenix, AZ 85085 United States

Re: K123156

Trade/Device: Gore Flow Reversal System Model Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: October 3, 2012 Received: November 13, 2012

Dear Ms. Alexander:

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.

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

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Page 2 - Ms. Sharon Alexander

device-related 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. Special 510(k) GORE® Flow Reversal System

### INDICATIONS FOR USE STATEMENT 4

# Indications for Use

510(k) Number (if known):

K123156

Device Name:

GORE® Flow Reversal System

Indications for Use:

The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:

- Adequate iliac/femoral access .
- Common carotid artery diameters between 6 and 12 mm ●
- External carotid artery diameters less than 6 mm .

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sinn-Ori) 510 h; Number

GORE and Design are Trademarks of W. L. Gore & Associates, Inc. Confidential Information

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