GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING

K121234 · W. L. Gore & Associates, Inc. · DYB · Nov 20, 2012 · Cardiovascular

Device Facts

• Record ID: K121234
• Device Name: GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Device Story

The GORE® DrySeal Sheath is an introducer sheath system used in the vasculature to facilitate endovascular device insertion while minimizing blood loss. The device comprises a polyethylene introducer sheath with a tapered tip and radiopaque marker band, a dilator for vessel access, and a DrySeal Valve. The valve consists of an outer silicone tube and an inner film tube; the space between these tubes is pressurized with 2.5mL of saline via a provided syringe to create a seal. The device is used by clinicians in a procedural setting. The addition of a hydrophilic coating improves lubricity during insertion. The device functions as a mechanical conduit; it does not involve electronic processing, AI, or software.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11135-1), packaging integrity, product shelf-life, and design verification testing (lubricity and particulation comparative analysis).

Technological Characteristics

Polyethylene introducer sheath with tapered tip and radiopaque marker band; DrySeal Valve (silicone/film construction) pressurized with 2.5mL saline; hydrophilic coating for lubricity. Sterilization via validated methods. Complies with ANSI/AAMI/ISO 10993 for biocompatibility.

Indications for Use

Indicated for patients requiring vascular access for the insertion of endovascular devices, serving as a conduit to minimize blood loss during the procedure.

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® DrySeal Sheath (K093791)

Submission Summary (Full Text)

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K121234

510(k) Premarket Notification GORE® DrySeal Sheath Conclusion (Statement of Equivalence)

# 510(K) SUMMARY

#### NOV 2 0 2012

Device Name:

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Product Code:

Date Summary Prepared:

Contact Person:

#### GORE® DrySeal Sheath with hydrophilic coating

GORE® DrySeal Sheath with hydrophilic coating

Introducer Sheath

Catheter, Introducer (per 870.1340)

Class II

DYB

April 17, 2012 October 5, 2012, revised

Alicia L. Hemphill, M.S., RAC

Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86002-0500

Telephone: [phone] Facsimile: [phone] E-mail: [e-mail]

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### Device Description

The GORE® DrySeal Sheath consists of a hydrophilic coated introducer sheath with GORE® DrySeal Valve attached, a dilator, and a syringe.

The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE® DrySeal Valve.

The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device.

The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.

### Device Modification

A hydrophilic coating has been added to the GORE® DrySeal Sheath. No other changes were made to the proposed device from that cleared under K093791.

#### Predicate Devices

#### GORE® DrySeal Sheath with hydrophilic coating:

GORE® DrySeal Sheath (K093791)

#### Indications

The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

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### Biocompatibility

Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ANSI/AAMI/ISO 10993.

| Test | Test Description | Result<br>(Pass/Fail) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------|
| Cytotoxity<br>ISO 10993-5 | MEM Assay (qualitative) | Pass |
| 1Sensitization<br>ISO 10993-10 | Murine Local Lymph Node<br>Assay | Pass |
| Intracutaneous<br>Reactivity<br>ISO 10993-10 | Intracutaneous Irritation Test | Pass |
| Acute System Toxicity<br>ISO 10993-11<br>ISO 10993-12 | Acute Systemic Study in Mice | Pass |
| Hemocompatibility<br>ISO 10993-4<br>ISO 10993-12 | Complement Activation<br>Hemolysis Assay<br><i>In vivo</i> Thrombogensis<br>Prothrombin Time Assay | Pass |
| Pyrogenicity<br>ISO 10993-11<br>ISO 10993-12 | Rabbit Pyrogen Test | Pass |

1 Additional Sensitization Testing Submitted September 18, 2012

### Substantial Equivalence

#### GORE® DrySeal Sheath, W. L. Gore & Associates, K093791.

Documentation provided includes a detailed comparison which demonstrates that the proposed GORE® DrySeal Sheath hydrophilic coated introducer sheath is substantially equivalent to the predicate GORE® DrySeal Sheath cleared under K093791. A hydrophilic coating has been added to the GORE® DrySeal Sheath. No other changes were made to the introducer sheath, DrySeal Valve or dilator from that cleared under K093791.

Additionally, the following tests/evaluations were performed to confirm equivalence to the predicate device:

- Biocompatibility .
- Sterilization Validations .
- Packaging Integrity .
- Product Shelf-Life .

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510(k) Premarket Notification GORE® DrySeal Sheath Conclusion (Statement of Equivalence)

- Design Verification .
Any differences in the technological characteristics do not raise any new issues of safety and efficacy.

The results demonstrate that the lubricity of the GORE® DrySeal Sheath with hydrophilic coating performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate device.

### Conclusion

Any differences in the technological characteristics do not raise any new issues of safety and efficacy. In terms of intended use, design, material composition and technological characteristics, the GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the 510(k) predicate device.

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### Testing in Support of Substantial Equivalence Determination

| Performance Testing | Applicable Test Standard |
|---------------------------|--------------------------------------|
| Lubricity | Comparative Analysis |
| Particulation | Comparative Analysis |
| Biocompatibility | ANSI/AAMI/ISO 10993-1 |
| Sterilization Validation | ANSI/AAMI/ISO 11135-1<br>AAMI TIR 28 |
| Product Expiration Dating | Gore Internal Procedures |

### Conclusion

The proposed device meets the performance criteria of design verification as specified by test protocols. The GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of an abstract human figure with three flowing lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 0 2012

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

Re: K121234

Trade/Device Name: GORE® DrySeal Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 13, 2012 Received: November 15, 2012

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. 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

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Page 2 - Ms. Alicia Hemphill

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 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.

Matthew G.
Hillebrenner

Digitally signed by Matthew G.
Hillebrenner
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300213272,
cn=Matthew G. Hillebrenner
Date: 2012.11.20 10:48:56 -05'00'

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

Enclosure

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510(k) Premarket Notification GORE® DrySeal Sheath Indication For Use

## INDICATION FOR USE

510(k) Number (if known):

K121234 TBD

Device Name:

GORE® DrySeal Sheath with hydrophilic coating

Intended Use / Indication For Use:

The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.S. Klleber

on of Cardiovascular Devices

**510(k) Number** K121234

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