(160 days)
Not Found
No
The summary describes a physical vascular graft and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a vascular graft intended for replacement or bypass of diseased vessels, which is a therapeutic intervention.
No
The device is a vascular graft, used for replacement or bypass of diseased vessels. It does not perform any diagnostic function; rather, it is a therapeutic implant.
No
The device description clearly states it is a synthetic graft made of ePTFE, which is a physical material, not software. The performance studies also focus on physical properties like burst strength and suture pullout strength.
Based on the provided information, the GORE® PROPATEN® Vascular Graft is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as vascular prostheses for replacement or bypass of diseased vessels in patients. This indicates it's a device used directly within the body for treatment or repair.
- Device Description: The description details a synthetic graft made of ePTFE with a heparin coating, designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the GORE® PROPATEN® Vascular Graft is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DSY, DYF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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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).
1
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
2
Indications for Use
510(k) Number (if known) K232312
Device Name GORE® PROPATEN® Vascular Graft
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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.
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.
4
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.