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 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.

AI/ML Overview

The GORE® DrySeal Sheath with hydrophilic coating, referenced in K121234, is an introducer sheath designed to provide a conduit for endovascular devices while minimizing blood loss. The primary modification from the predicate device (K093791) is the addition of a hydrophilic coating. The study primarily focuses on demonstrating substantial equivalence to the predicate device, with a particular emphasis on the performance of the new hydrophilic coating.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device meets the requirements of applicable standards and performs as designed and comparably to the predicate device.

Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Meets requirements of ANSI/AAMI/ISO 10993	"Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ANSI/AAMI/ISO 10993." (All individual tests listed as "Pass")
Cytotoxicity	Pass MEM Assay (qualitative)	Pass
Sensitization	Pass Murine Local Lymph Node Assay	Pass
Intracutaneous Reactivity	Pass Intracutaneous Irritation Test	Pass
Acute Systemic Toxicity	Pass Acute Systemic Study in Mice	Pass
Hemocompatibility	Pass Complement Activation, Hemolysis Assay, In vivo Thrombogenesis, Prothrombin Time Assay	Pass
Pyrogenicity	Pass Rabbit Pyrogen Test	Pass
Sterilization Validation	Meets requirements of ANSI/AAMI/ISO 11135-1, AAMI TIR 28	Tests were performed and found to confirm equivalence to the predicate device.
Packaging Integrity	Demonstrated integrity	Tests were performed and found to confirm equivalence to the predicate device.
Product Shelf-Life	Demonstrated shelf-life	Tests were performed and found to confirm equivalence to the predicate device.
Design Verification	Meets specified performance criteria	"The proposed device meets the performance criteria of design verification as specified by test protocols."
Lubricity	Comparable to predicate device; performs as designed	"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."
Particulation	Comparable to predicate device	Comparative analysis performed.
Overall Substantial Equivalence	No new issues of safety and efficacy compared to predicate	"Any differences in the technological characteristics do not raise any new issues of safety and efficacy."

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each test. The studies appear to be laboratory-based and conducted by W. L. Gore & Associates, Inc. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal company testing. The studies are not clinical trials and thus the terms "retrospective" or "prospective" do not directly apply in the usual clinical sense. These are pre-market device verification and validation tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a 510(k) submission for a device like an introducer sheath undergoing mechanical and biological testing. The "ground truth" for these tests is established by adhering to recognized international standards (e.g., ISO, AAMI) and internal test protocols, not by expert medical consensus on individual cases. The expertise lies in the engineers and scientists conducting and evaluating the tests against these standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. Performance is assessed against pre-defined success/failure criteria based on established standards and design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-enabled device or a diagnostic device involving human interpretation where MRMC studies would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an algorithm or AI-based device. The device itself is evaluated for its physical and biological performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is based on:

International Standards: e.g., ANSI/AAMI/ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135-1 for sterilization.
Comparative Analysis: Ensuring the new device's performance (e.g., lubricity, particulation) is equivalent to or better than the legally marketed predicate device (K093791).
Design Specifications: Meeting internal design verification protocols ("The proposed device meets the performance criteria of design verification as specified by test protocols.").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device would refer to its design and engineering development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI/ML algorithm.

Summary

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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

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: (928) 864-4328 Facsimile: (928) 864-4304 E-mail: ahemphil@wlgore.com

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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 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

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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(Pass/Fail)
CytotoxityISO 10993-5	MEM Assay (qualitative)	Pass
1SensitizationISO 10993-10	Murine Local Lymph NodeAssay	Pass
IntracutaneousReactivityISO 10993-10	Intracutaneous Irritation Test	Pass
Acute System ToxicityISO 10993-11ISO 10993-12	Acute Systemic Study in Mice	Pass
HemocompatibilityISO 10993-4ISO 10993-12	Complement ActivationHemolysis AssayIn vivo ThrombogensisProthrombin Time Assay	Pass
PyrogenicityISO 10993-11ISO 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 11135-1AAMI 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 (800) 638-2041 or (301) 796-7100 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:

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

Page 3 of 43

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).