GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Device Description

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GORE® PROPATEN® Vascular Graft. This type of FDA submission is for medical devices and does not involve an AI/ML algorithm. Therefore, the device does not have acceptance criteria, a study proving it meets acceptance criteria, or any of the other AI/ML-specific information requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or how training set ground truth was established).

The document details the device, its intended use, predicate devices, and a summary of performance testing conducted to demonstrate substantial equivalence to the predicate device. These tests are physical and material property tests related to the vascular graft's design and manufacturing, not AI/ML performance.

Therefore, I cannot provide the requested information as it is not applicable to the provided document.

Summary

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January 9, 2024

W. L. Gore & Associates, Inc. Sarah Pastrnak Regulatory Affairs Associate 1505 N. Fourth Street Flagstaff, Arizona 86004

Re: K232312

Trade/Device Name: GORE® PROPATEN® Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY, DYF Dated: August 2, 2023 Received: December 4, 2023

Dear Sarah Pastrnak:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Rohini Retarekar -S

for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232312

Device Name GORE® PROPATEN® Vascular Graft

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K232312 510(k) Summary

510(k) Submitter

W. L. Gore & Associates, Inc. 1505 North Fourth Street Flagstaff. AZ 86004

Requlatory Contact: Sarah Pastrnak

Phone: 928 864 4146

E-mail: spastrna@wlgore.com

Date Prepared

8 Jan 2024

Device Names/Classification

Device Name: GORE® PROPATEN® Vascular Graft

Classification Name: Vascular Graft

Requlation: 21 CFR 870.3450

Classification: II

Product Code: DSY, DYF

Predicate Devices

K062161, GORE® PROPATEN® Vascular Graft

Device Description

Indications for Use

GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Differences in Technological Characteristics

The subject and predicate GORE® PROPATEN® Vascular Graft have the same fundamental technology, CBAS® Heparin coating, sterilization method, and same intended use.

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The subject GORE® PROPATEN® Vascular Graft includes an alternate packaging configuration and additional configurations, including the GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral, GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt, and GORE® PROPATEN® Vascular Graft Integrated Ring.

Summary of Performance Testing

The following testing was conducted to demonstrate substantial equivalence to the predicate device:

. Packaging Integrity
. Packaging shelf-life evaluation
. Coating stability testing
Sterilization testing ●
Dimensional evaluation .
Burst Strength
. Suture Pullout Strength
Tensile Strength
Water Entry Pressure ●
Kink Radius
Puncture Burst .
Puncture Leak
. Biocompatibility per ISO 10993

Additional testing was performed on the new configurations, including:

. Suture Line Leak
Bubble Point ●
FEP Adhesion (Ring Pull) ●
Compression Resistance

Conclusion

The GORE® PROPATEN® Vascular Graft is substantially equivalent to the predicate devices. The additional packaging configuration and device configurations did not raise new types of safety or effectiveness questions, and the testing provided in this application supports a determination of substantial equivalence.

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.”