The GORE® ACUSEAL Vascular Graft is a multilayer graft design comprised of expanded polytetrafluoroethylene (ePTFE) separated by an elastomeric layer and may be available both with and without covalently bound bioactive heparin on the luminal surface of the device (commonly known as the Carmeda® BioActive Surface, or CBAS® heparin). The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

AI/ML Overview

The GORE® ACUSEAL Vascular Graft is primarily intended for use as a vascular prosthesis in patients requiring vascular access. The device demonstrated substantial equivalence to predicate devices through in vitro, in vivo animal, and in vivo clinical testing.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Endpoint)	Performance Criterion / Historical Control	Reported Device Performance (GORE® ACUSEAL)	Notes
In Vivo Animal Testing (Canine Model)
Intra-Operative Suture Line Bleeding	Equivalent to currently marketed devices	No intra-operative suture line bleeding	This suggests excellent initial hemostasis at the surgical site.
Post-Cannulation Time-to-Hemostasis	Comparable to or significantly lower than predicate devices	Comparable to or significantly lower than predicate devices	Indicates effective sealing after needle punctures, crucial for vascular access devices.
Device Patency	Remains patent and in position	Remained widely patent throughout the in-life period	Angiographic imaging confirmed sustained blood flow. CT scans showed no kinking.
Histological Response	Similar to currently marketed grafts	Comparable to predicate vascular grafts	Evaluates tissue integration and inflammatory response; a comparable response indicates good biocompatibility.
In Vivo Clinical Trial (Human)	Historical Control	GORE® ACUSEAL	Interpretation
Primary Efficacy: Cumulative Patency at 6 months	75%	84%	GORE® ACUSEAL demonstrated superior cumulative patency, exceeding the historical control.
Secondary Efficacy: Primary Unassisted Patency	42%	46%	Slightly improved primary unassisted patency, although the document states "comparable."
Primary Safety: Freedom from Bleeding at 6 months	78%	88%	GORE® ACUSEAL demonstrated superior freedom from bleeding, exceeding the historical control. This includes major or minor bleeding events.
Time to First Cannulation (24 hours)	Not explicitly defined as a criterion	22.2% (N=30/135)	This data indicates a significant portion of grafts were cannulated quickly. Median time to first cannulation was 5 days, and for those within 24 hours, the median was 21 hours. This is a key advantage for patients requiring early dialysis.
Time to Third Consecutive Hemodialysis (within 28 days)	Not explicitly defined as a criterion	75.6%	This endpoint addresses quick reliance on the graft for dialysis, which can lead to earlier removal of temporary central venous catheters (CVCs), reducing CVC-related complications.
Device Related Adverse Events / Deaths	None	None	The absence of device-related adverse events or deaths is a strong indicator of safety.

Note: For in vitro tests (Wall Thickness, Internal Diameter, Suture Retention, Kink Radius, Punctured Burst, Punctured Leak, Burst Testing, Fibril Length, Water Entry Pressure (WEP), Tensile Strength, Pressurized Internal Diameter), the document states that results "demonstrate that the technological characteristics and performance criteria of the devices are comparable and equivalent" to predicate devices. Specific numerical acceptance criteria were not provided in the summary but were met.

2. Sample Size Used for the Test Set and Data Provenance:

In-Vivo Animal Study:
- Sample Size: Not explicitly stated, but the study was conducted in a "canine model" and tested "4 device attributes." Typically, these studies involve a small number of animals per test group.
- Data Provenance: Prospective, animal model (canine).
In-Vivo Clinical Trial:
- Sample Size: 138 subjects.
- Data Provenance: Multi-centered, prospective, single-arm clinical trial. The location (country of origin) is not explicitly stated, but as it's a 510(k) submission to the FDA, it's highly likely to include US-based centers. The "historical controls" data would have been derived from existing literature or internal company data from previously marketed devices.

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

In-Vivo Animal Study: Not explicitly stated. For animal studies, the "ground truth" (e.g., histological response, patency) is typically established by veterinary pathologists, surgeons, and imaging specialists. Qualifications would generally be board certification or equivalent experience in their respective fields.
In-Vivo Clinical Trial: The ground truth for endpoints such as cumulative patency, freedom from bleeding, and time to cannulation would have been established by the clinical investigators (physicians/surgeons) involved in the multi-centered trial, supported by objective measurements (e.g., hemodynamic evidence of blood flow, clinical documentation of bleeding events). Their qualifications would be as medical professionals (e.g., vascular surgeons, nephrologists) experienced in managing patients requiring vascular access for hemodialysis. The exact number of experts in each center or for overall data review is not specified.

4. Adjudication Method for the Test Set:

In-Vivo Animal Study: Not explicitly stated.
In-Vivo Clinical Trial: Not explicitly stated. For a multi-centered clinical trial, endpoints are typically defined in the study protocol, and data is collected according to these definitions. It is common for adverse events and efficacy endpoints to undergo an adjudication process by an independent clinical events committee (CEC) to ensure consistency and minimize bias, especially for subjective assessments. However, the document does not specify if such a method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This is not applicable. The GORE® ACUSEAL Vascular Graft is a physical medical device (vascular prosthesis), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers was not performed. The "readers" in this context would be the clinicians assessing the patient outcomes directly.

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

This is not applicable. As mentioned above, the GORE® ACUSEAL Vascular Graft is a physical medical device, not an algorithm or software. Its performance is evaluated based on its biological, mechanical, and clinical characteristics, not as a standalone AI system.

7. The Type of Ground Truth Used:

In-Vivo Animal Study:
- Intra-Operative Suture Line Bleeding: Direct observation by surgeons.
- Post-Cannulation Time-to-Hemostasis: Direct observation and measurement.
- Device Patency: Angiographic imaging (objective assessment of blood flow) and CT scans (objective assessment of kinking).
- Histological Response: Pathological examination of tissue samples by trained pathologists.
In-Vivo Clinical Trial:
- Cumulative Patency: Hemodynamic evidence of blood flow (objective measurement), presumably through clinical assessment, Doppler ultrasound, or angiography as per study protocol.
- Freedom from Bleeding: Clinical documentation and reporting of bleeding events (e.g., hematoma, incision site bleeding, gastrointestinal bleeding, rectal bleeding, hemoptysis).
- Time to First Cannulation: Clinical records of when the graft was first accessed.
- Time to Third Consecutive Hemodialysis: Clinical records of dialysis sessions.
- Adverse Events/Deaths: Clinical reporting and monitoring.

8. The Sample Size for the Training Set:

This is not applicable in the context of device approval for a physical medical implant. There is no "training set" in the machine learning sense. The clinical trial data for the GORE® ACUSEAL Vascular Graft serves as the evaluation set. The "training" for the device's design would come from engineering principles, pre-clinical testing, and experience with predicate devices.

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

This is not applicable as there is no "training set" for an AI model. For the development of the device itself, the "ground truth" guiding its design and iterative improvements comes from:
- Engineering specifications and material science: Based on known properties of ePTFE and elastomer.
- Bench testing data: In vitro tests (e.g., tensile strength, burst pressure) establishing mechanical properties against engineering standards and comparability to predicate devices.
- Pre-clinical animal data (prior to this specific study): Early phase animal studies to understand basic biocompatibility and performance characteristics, guiding design modifications.
- Clinical experience with predicate devices: Understanding the performance and failure modes of existing vascular grafts (GORE® PROPATEN®, GORE-TEX® Stretch, Vascutek® SEALPTFE™) informed the design of the GORE® ACUSEAL graft.

Summary

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K130215

510(k) Premarket Notification GORE® ACUSEAL Vascular Graft 510(k) Summary of Substantial Equivalence

APR 0 9 2013

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

GORE® ACUSEAL Vascular Graft Proprietary Name: Common Name: Vascular Graft Prosthesis, Vascular Graft, 6 mm and greater diameter Classification Name: Prosthesis, Vascular Graft, of less than 6 mm in diameter (per 21 CFR 870.3450) Device Classification: Class II Product Classification and Code: DSY Classification Panel: Cardiovascular Devices Establishment Registration Number: 2017233 Contact Person: Michael Ivey Regulatory Affairs Medical Products Division W.L. Gore and Associates 3250 W. Kiltie Lane Flagstaff, AZ 86001

Telephone: 928-864-3790 Facsimile: 928-779-4219 E-mail: mivey@wlgore.com

Performance Standards

There are no applicable standards with recognized performance criteria that currently exist for these devices. None are established under Section 514.

Device Description

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510(k) Premarket Notification GORE® ACUSEAL Vascular Graft 510(k) Summary of Substantial Equivalence

device (commonly known as the Carmeda® BioActive Surface, or CBAS® heparin). The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

Indications for Use

The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

Substantially Equivalent Devices

The following devices as substantially equivalent predicate devices listed below:

GORE® PROPATEN® Vascular Graft (K062161) .
GORE-TEX® Stretch Vascular Graft (K903931) .
Vascutek® Ltd SEALPTFETM ePTFE Vascular Prosthesis (K030999) .

Brief Comparison Summary

To demonstrate substantial equivalence of the applicant GORE® ACUSEAL Vascular Graft to the predicate devices, technological characteristics and performance criterion were evaluated using in vitro and in vivo testing as indicated below:

In Vitro Testing

Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:

Wall Thickness .
Internal Diameter ●
Suture Retention (transverse and longitudinal) ●
Kink Radius (Pressurized and Non-Pressurized)
Punctured Burst
Punctured Leak ●
. Burst Testing
Fibril Length .
Water Entry Pressure (WEP) ●
Tensile Strength Fibril Length .
Pressurized Internal Diameter

The in-vitro test results of GORE® ACUSEAL Vascular Graft and the other predicate devices demonstrate that the technological characteristics and performance criteria of the devices are comparable and equivalent and that GORE® ACUSEAL Vascular Graft can perform in a manner equivalent to devices currently available on the market.

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In Vivo Animal Testing

To further assess the performance of the GORE® ACUSEAL Vascular Graft, as well as evaluate the biocompatibility of the graft in a vascular application, an in vivo study was conducted in a canine model to evaluate 4 device attributes:

. Intra-Operative Suture Line Bleeding: The implanted device demonstrates equivalent intra-operative suture line bleeding compared to currently marketed devices
. Post-Cannulation Time-to-Hemostasis: the device achieves hemostasis successfully post cannulation and allows for closure of the incision site by the surgeon.
Device Patency: The implanted device remains patient and in position . throughout the in-life period in the canine model.
. Histological Response: device demonstrates tissue response similar to currently marketed grafts.

In vivo animal results demonstrate that the GORE® ACUSEAL Vascular Graft had no intra-operative suture line bleeding during implant. Devices achieved hemostasis successfully post cannulation in that the test devices had a time-to-hemostasis comparable to or significantly lower than that of the predicate devices. Angiographic imaging demonstrated that the devices remained widely patent throughout the in-life period in the canine model. CT scans showed no evidence of device kinking during the in-life period. The histological profile of the GORE® ACUSEAL Vascular Graft was comparable to predicate vascular grafts.

In Vivo Clinical Data

A 138-subject, multi-centered, prospective, single arm clinical trial was conducted to compare the GORE® ACUSEAL Vascular Graft to historical controls in patients requiring arteriovenous access grafts for hemodialysis.

The primary efficacy endpoint was cumulative patency at 6 months, determined by hemodynamic evidence of blood flow. The primary safety endpoint was freedom from bleeding at 6 months defined as percent of subjects free from major or minor bleeding including hematoma, incision site bleeding, gastrointestinal bleeding, rectal bleeding, and hemoptysis. The study also documented the time to first hemodialysis access and first three consecutive hemodialysis sessions.

At the end of the 6-month follow-up, the primary endpoint of cumulative patency for the GORE® ACUSEAL Vascular Graft was 84% compared to the historical control of 75%. The secondary endpoint of primary unassisted patency for the GORE® Vascular Graft was 46% compared to the historical control of 42%. In addition, freedom from bleeding (defined as any occurrence of reported bleeding from any source including but not limited to gastrointestinal bleeds, hemoptysis, extravasations, incision site bleeds, etc) was 88% in the GORE® ACUSEAL Vascular Graft group

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510(k) Premarket Notification GORE® ACUSEAL Vascular Graft 510(k) Summary of Substantial Equivalence

compared to 78% in the historical control group. There were no device related adverse events or device related deaths reported in the study.

As part of a secondary endpoint of the GORE® ACUSEAL Vascular Graft clinical study, the time from initial graft implantation of the graft to the time of first cannulation was collected and analyzed. This data is summarized below:

Time till GraftCannulation	Number ofACUSEAL GraftsCannulated
24 Hours	N=30/135 (22.2%)
48 Hours	N=48/135 (35.6%)
72 Hours	N=54/135 (40.0%)
7 Days	N=70/135 (51.9%)

Table 1: Time to First Cannulation post Graft Implantation

The median days to first cannulation through the study graft was 5 days with a range of 0-116 days. For patients cannulated within the first 24 hours, the median time to first cannulation of the study graft was 21 hours with a range of 2 hours to 24 hours.

An additional secondary endpoint of the GORE® ACUSEAL Vascular Graft clinical study, for the subjects presenting with a central venous catheter (CVC), the time from initial graft implantation to the third consecutive use of the graft for hemodialysis was collected and analyzed. Within 28 days of graft implantation 75.6% of the implanted GORE® ACUSEAL Vascular Grafts had been successfully cannulated 3 consecutive times and allowing for the potential for the CVC catheter to be removed.

The clinical data demonstrate that the GORE® ACUSEAL Vascular Graft has comparable clinical performance to that of the predicate grafts.

Conclusion (Statement of Equivalence)

W. L. Gore and Associates believes that the data presented in this application, including in vitro testing, in vivo data, along with numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the GORE® ACUSEAL Vascular Graft through this 510(k) Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, representing health and well-being.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2013

W. L. Gore & Associates, Inc. Attn: Mr. Michael Ivey Regulatory Affairs Medical Products Division 3250 W. Kiltie Lane Flagstaff, AZ 86001

Re: K130215

Trade/Device Name: GORE® ACUSEAL Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: January 28, 2013 Received: January 29, 2013

Dear Mr. Ivey:

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 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

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Page 2 - Mr. Michael Ivey

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Matthew GHillebrenner

for

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

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510(k) Premarket Notification
GORE® ACUSEAL Vascular Graft Indication For Use

INDICATION FOR USE

510(k) Number (if known):

K130215

Device Name:

GORE® ACUSEAL Vascular Graft

Intended Use / Indication For Use:

The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

Prescription Use	OR Over-The-Counter Use
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G. Hillebrenner

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”