GORE INTRODUCER SHEATH

K013282 · W. L. Gore & Associates, Inc. · DBY · Dec 14, 2001 · Immunology

Device Facts

• Record ID: K013282
• Device Name: GORE INTRODUCER SHEATH
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DBY · Immunology
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5520
• Device Class: Class 1

Intended Use

The GORE Introducer Sheath is used to facilitate the introduction of guidewires, catheters and other interventional medical devices into the vasculature, and to minimize blood loss associated with such introduction.

Device Story

GORE Introducer Sheath provides vascular access for interventional procedures; facilitates introduction of guidewires, angiographic catheters, balloon catheters, and endovascular devices. Device components include introducer sheath, sheath hub, cap, hemostasis valve, and dilator (tube and valve body). Used by clinicians in clinical settings to access vasculature; minimizes blood loss during device exchange. Biocompatible construction; provided sterile. Functionally equivalent to predicate device; no new safety or effectiveness questions raised.

Clinical Evidence

bench testing only

Technological Characteristics

Introducer sheath system comprising sheath, hub, cap, hemostasis valve, and dilator. Manufactured using biocompatible materials, standard manufacturing processes, and sterilization methods consistent with the predicate device.

Indications for Use

Indicated for the introduction of guidewires, catheters, and other interventional medical devices into the vasculature, while minimizing blood loss during the procedure.

Regulatory Classification

Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

Predicate Devices

• FAST-CATH™ Hemostasis Introducer (St. Jude Medical, DAIG Division)

Submission Summary (Full Text)

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## DEC 1 4 2001

Attachment 4

510 (k) Premarket Notification

K013282

GORE® Introducer Sheath

## Premarket Notification 510(k) Summary

W.L. Gore & Associates, Inc. Submitted By: A. P.O. Box 500 Flagstaff, AZ 86002-0500

> October 1, 2001 Date Prepared:

R. Larry Pratt Contact:

> 928-779-2771 Phone:

- GORE® Introducer Sheath Device Name: B.
- Applicant Device Description: C.

The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatible materials and is provided sterile.

The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .

- Predicate Device: D.
The currently marketed FAST-CATH™ Hemostasis Introducer manufactured by St. Jude Medical, DAIG Division is cited as the predicate device which has been found to be che predicate device and the premarket notification process .

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- に. Applicant Device Labeling:
Like the predicate device, the applicant device is indicated for the introduction of guidewires, catheters and other interventional medical devices into the vasculature, and to minimize blood loss associated with such introduction.

- Technological Characteristics: F.
The technological characteristics of the applicant device are substantially equivalent to those of the predicate The applicant device is manufactured using the device. same manufacturing process, the same biocompatible materials, the same quality specifications, the same packaging materials and process and the same sterilization process as the predicate device.

- Safety and Effectiveness Conclusions: র .
This submission represents only a slight modification to the Instructions For Use for the applicant device as compared to the currently marketed predicate device. Therefore, the similarities between the applicant and predicate device are numerous. These equivalencies combine to justify a substantially equivalent determination.

No new types of safety and effectiveness questions are raised by the applicant device when compared to the predicate device.

GORE® is a trademark of W.L. Gore & Associates. FAST-CATH™ and DAIG are trademarks of St. Jude Medical, DAIG Division.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 2 2 2010

W. L. Gore & Associates, Inc. c/o Ms. Laurie Garlant P.O. Box 500 Flagstaff, AZ 86002-0500

Re: K013282 GORE® Introducer Sheath Regulation Number: 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: II Product Code: DYB Dated (Date on orig SE Itr): December 14, 2001 Received (Date on orig SE Itr): October 2, 2001

Dear Ms. Garlant:

This letter corrects our substantially equivalent letter of December 14, 2001 (date of original SE letter).

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 (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 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

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Page 2 - Ms. Laurie Garlant

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 (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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

er R-be.hner

Image /page/3/Picture/7 description: The image contains a handwritten signature or symbol on the left, followed by the letters 'B' and 'D' on the right. The signature appears to be a series of connected, curved lines. The letters 'B' and 'D' are printed in a simple, sans-serif font and are vertically aligned.

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

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## Page 3 – Ms. Laurie Garlant

Prepared by:myb:03/15/01

Enclosure [ONLY NEED ENCLOSURE FOR 1996 FILES THAT HAVE INDICATIONS FOR USE STATEMENTS]

| Div/Branch | Last Name | Date | Div/Branch | Last Name | Date |
|------------|-------------------|---------|------------|-----------|------|
| DCP/ICDB | Hwang | 3-15 | | | |
| DCD/ICDB | Franczak for Boam | 3/15 | | | |
| DCD | Vulner | 3/18/10 | | | |

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510(k) Number (if known): __ KO13282

Device Name:_GORE®Introducer Sheath

Indications For Use:

The GORE Introducer Sheath is used to facilitate the introduction The GORE Introducer Sheath Is assurt ions medical devices of guidewires, catherers and other investible with such introduction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Walk Teth

Division of Cardiovascular & Respiratory Devices
510(k) Number K013282

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)