GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

K082356 · W. L. Gore & Associates, Inc. · DYB · Aug 28, 2008 · Cardiovascular

Device Facts

• Record ID: K082356
• Device Name: GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The GORE Introducer Sheath with Silicone Pinch Valve is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood los associated with such introduction.

Device Story

The GORE Introducer Sheath with Silicone Pinch Valve is a vascular access device used to facilitate the introduction of catheters and other medical devices into the patient's vasculature. It incorporates a silicone pinch valve designed to minimize blood loss during the procedure. The device is operated by clinicians in a clinical setting. This specific submission introduces an additional 18Fr size to the existing product line. The device functions as a conduit for interventional tools, and its use helps maintain hemostasis during vascular access procedures, potentially reducing blood loss for the patient.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Introducer sheath with integrated silicone pinch valve. Modification adds an 18Fr size to the existing product line. No changes to materials or principle of operation.

Indications for Use

Indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• GORE Introducer Sheath with Silicone Pinch Valve (K032073)

Submission Summary (Full Text)

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## SPECIAL 510(k) SUMMARY

# AUG 2 8 2008

#### Applicant:

W. L. Gore and Associates, Inc. 1505 North Fourth St. Flagstaff, AZ 86004

#### Contact:

Alicia L. Hemphill Regulatory Affairs Associate 3450 W. Kiltie Lane Flagstaff, AZ 86001

Phone - [phone] Fax - [phone]

## Date Prepared:

Aug 15, 2008

## Proprietary Device Name:

GORE Introducer Sheath with Silicone Pinch Valve

Common Name: Introducer Sheath

Class II Classification: 21CFR 870.1340, DYB

#### Device Predicate:

K032073 GORE Introducer Sheath with Silicone Pinch Valve

#### Device Description:

This 510(k) is being submitted for a minor modification to the product configuration made to the GORE Introducer Sheath with Silicone Pinch Valve cleared under K032073. The proposed modification that is subject of this 510(k) submission is to offer an additional 18Fr size introducer sheath to the current product line. No other changes are being made to the GORE Introducer Sheath with Silicone Pinch Valve or its packaging as cleared under K032073.

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Statement of Intended Use:

The GORE Introducer Sheath with Silicone Pinch Valve is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood los associated with such introduction.

Note: The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

# Technological Characteristics:

The sole difference between the predicate GORE Introducer Sheath with Silicone Pinch Valve and the GORE Introducer Sheath with Silicone Pinch Valve which is subject of this 510(k) submission is the additional 18Fr device size.

## Substantial Equivalence:

A variety of tests, assessments, and comparisons demonstrate that the GORE Introducer Sheath with Silicone Pinch Valve is substantially equivalent to its predicate in terms of design, intended use, principle of operation, and performance attributes.

Differences between the predicate GORE Introducer Sheath device and the proposed GORE Introducer Sheath device with the additional 18Fr device size do not raise any significant issues of safety or effectiveness.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2008

W. L. Gore & Associates, Inc. c/o Ms. Alicia Hemphill Regulatory Affairs 3450 W. Kiltie Lane Flagstaff, AZ 86001

Re: K082356

GORE Introducer Sheath with Silicone Pinch Valve. Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: August 11, 2008 Received: August 18, 2008

Dear Ms. Hemphill:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Alicia Hemphill

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toate of a riod a determination that your device complies with other requirements of the Act that I Dreal statutes and regulations administered by other Federal agencies. You must or any I violal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) r ms letter watification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket prease ventual of 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

R. Lachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082356

Device Name: GORE Introducer Sheath with Silicone Pinch Valve

Indications For Use:

The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Lahn

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K08235 65