The GORE DrySeal Sheath 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 an 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

Here's an analysis of the provided text regarding the GORE DrySeal Sheath, focusing on acceptance criteria and the supporting study information.

It's important to note that this document is a 510(k) Summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or effectiveness through extensive clinical trials. Therefore, the "study" referred to will be primarily bench testing (in-vitro performance and biocompatibility) rather than a clinical study in the traditional sense of comparing outcomes or measuring human reader performance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" alongside specific numerical results. Instead, it states that "In-vitro design verification testing data demonstrate that the device is in compliance with ISO 11070 Sterile, single use intravascular catheter introducers and product labeling." and "The testing demonstrated acceptable results." for various tests.

Therefore, the acceptance criteria are implicitly defined as meeting the requirements of ISO 11070 and internal procedures for each test, and the reported device performance is simply that all tests yielded "acceptable results."

Here's the table based on the provided information:

Table 1: Acceptance Criteria and Reported Device Performance for GORE DrySeal Sheath

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Sheath Working Length	Compliance with ISO 11070 and/or internal procedures	Acceptable
Dilator Length	Compliance with ISO 11070 and/or internal procedures	Acceptable
Guidewire Compatibility	Compliance with ISO 11070 and/or internal procedures	Acceptable
Sheath Tip to Dilator Transition	Compliance with ISO 11070 and/or internal procedures	Acceptable
Sheath/Valve Assembly Length	Compliance with ISO 11070 and/or internal procedures	Acceptable
Dimensional Compatibility with Devices	Compliance with ISO 11070 and/or internal procedures	Acceptable
Radiodetectability	Compliance with ISO 11070 and/or internal procedures	Acceptable
Tortuosity	Compliance with ISO 11070 and/or internal procedures	Acceptable
Kink Resistance	Compliance with ISO 11070 and/or internal procedures	Acceptable
Force at Break	Compliance with ISO 11070 and/or internal procedures	Acceptable
Strength of Union	Compliance with ISO 11070 and/or internal procedures	Acceptable
Removal Force	Compliance with ISO 11070 and/or internal procedures	Acceptable
Freedom from Leakage	Compliance with ISO 11070 and/or internal procedures	Acceptable
Cytotoxicity	Compliance with ISO 10993 requirements	Met requirements
Sensitization	Compliance with ISO 10993 requirements	Met requirements
Intracutaneous Toxicity	Compliance with ISO 10993 requirements	Met requirements
Systemic Toxicity	Compliance with ISO 10993 requirements	Met requirements
Hemocompatibility	Compliance with ISO 10993 requirements	Met requirements
Hemolysis	Compliance with ISO 10993 requirements	Met requirements
Prothrombin Time	Compliance with ISO 10993 requirements	Met requirements
Complement Activation	Compliance with ISO 10993 requirements	Met requirements
Thrombogenicity	Compliance with ISO 10993 requirements	Met requirements
Pyrogenicity	Compliance with ISO 10993 requirements	Met requirements

Study Details

Based on the provided text, here's a breakdown of the study information:

Sample size used for the test set and the data provenance:
- Sample Size: Design Verification testing was conducted on "the 12 Fr and 26 French Size sheaths." This indicates at least these two sizes were tested. The exact number of units/samples per size tested for each specific benchmark test (e.g., how many sheaths were subjected to "Force at Break" testing) is not specified in this summary.
- Data Provenance: The tests are described as "in-vitro testing" and "Bench / Performance Data." This means the data was generated in a laboratory setting, not from human or animal subjects. The country of origin of the data is not specified, but the manufacturer (W. L. Gore & Associates, Inc.) is based in the USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission and study. The "ground truth" for these tests (e.g., whether a sheath conforms to a specific length, or if a material is cytotoxic) is established by adherence to documented ISO standards and internal procedures, using calibrated laboratory equipment and trained technicians, not by expert consensus in interpretation.
Adjudication method for the test set:
- This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or when interpreting subjective image data where expert consensus is needed to establish a definitive diagnosis or outcome. Here, the results are objective measurements against defined standards.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an introducer sheath, a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product or its evaluation as described in this 510(k) summary.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests (e.g., sheath length, kink resistance) is defined by objective measurements and adherence to ISO standards (e.g., ISO 11070) and internal test protocols.
- For biocompatibility tests, the ground truth is established by conformance to ISO 10993 standards, which involve specific laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/toxicity).
The sample size for the training set:
- This is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of its development and evaluation as described here.
How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of device.

Summary

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6093791

MAR 2 2 2010

510(K) SUMMARY

Device Name:

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Product Code:

Date Summary Prepared:

Contact Person:

GORE DrySeal Sheath

Introducer Sheath

Catheter, Introducer (per 870. 1340)

Class II

DYB

December 9, 2009 (revised March 12, 2010)

Alicia L. Hemphill 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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510(k) Premarket Notification GORE DrySeal Sheath 510(k) Summary

Intended Use

GORE DrySeal Sheath 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 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.

Predicate Devices

In terms of intended use, design, material composition and technological characteristics, the GORE DrySeal Sheath is substantially equivalent to the predicate devices. In vitro testing demonstrated that the GORE DrySeal Sheath met established acceptance criteria and that performance is comparable to the following predicate devices:

GORE Introducer Sheath . W. L. Gore & Associates, K013282

The GORE Introducer Sheath is comprised of the introducer sheath and dilator. 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. The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient temporary closure of the access site during catheter exchanges. The device allows introduction of angiographic catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel.

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GORE Introducer Sheath with Silicone Pinch Valve W. L. Gore & Associates, K032073, K082356

The GORE Introducer Sheath with Silicone Pinch Valve is an introducer sheath comprised of a sheath with an attached valve system, hemostasis caps and a dilator. The tip of the dilator is tapered to facilitate atraumatic insertion of the sheath. The valve system helps maintain hemostasis during endovascular procedures.

Technological Characteristics and Substantial Equivalence

The GORE DrySeal Sheath is substantially equivalent to the GORE Introducer Sheath with Silicone Pinch Valve (K032073, K082356) and the GORE Introducer Sheath (K013282). Devices comparisons show all products have similar intended use, French size, sheath effective length, tip configuration, lumen, flushing system, materials, sterilization method and packaging materials. All products are supplied as single use, sterile products.

Bench / Performance Data

The following in-vitro testing was performed on the GORE DrySeal Sheath in accordance with ISO standards and/or internal procedures to assure reliable design and performance. In-vitro design verification testing data demonstrate that the device is in compliance with ISO 11070 Sterile, single use intravascular catheter introducers and product labeling.

Sheath Working Length .
. Dilator Length
. Guidewire Compatibility
. Sheath Tip to Dilator Transition
. Sheath/Valve Assembly Length
. Dimensional Compatibility with Devices
� Radiodetectability
. Tortuosity
Kink Resistance .
Force at Break ●
Strength of Union .
Removal Force .
Freedom from Leakage .

Design Verification testing was conducted on the 12 Fr and 26 French Size sheaths. The testing demonstrated acceptable results.

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510(k) Premarket Notification GORE DrySeal Sheath 510(k) Summary

Biocompatibility

In accordance with ISO 10993-1:2003, the following biocompatibility tests were conducted on the GORE Dry Seal Sheath:

. Cytotoxicity
. Sensitization
. Intracutaneous Toxicity
Systemic Toxicity
Hemocompatibility .
Hemolysis ●
Prothrombin Time .
Complement Activation .
Thrombogencity .
Pyrogencity. .

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

Conclusion

The studies conducted on the GORE DrySeal Sheath demonstrate that the device is substantially equivalent to the predicate devices currently in commercial distribution.

The proposed device meets the performance criteria of design verification as specified by ISO standards and test protocols. The proposed device has the same intended use, size, technology, design and materials as the predicate devices. Any differences between the devices do not raise any significant issues of safety or effectiveness.

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Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design.

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

W.L. GORE & Associates, Inc. c/o Ms. Alicia L. Hemphill Regulatory Affairs Associate 3450 West Kiltie Lane Flagstaff, AZ 86003-2400

MAR 2 2 2010

Re: K093791

Trade/Device Name: GORE DrySeal Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 12, 2010 Received: March 15, 2010

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.

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Page 2 - Ms. Alicia L. Hemphill

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 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Juna R. Warner

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

INDICATION FOR USE

510(k) Number (if known):

我的一次的93791

Device Name:

GORE DrySeal Sheath

Intended Use / Indication For Use:

The GORE DrySeal Sheath 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 (Part 21 CFR 801 Subpart D) (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)

Durer R. Lulmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko93791

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).