(30 days)
Not Found
No
The 510(k) summary describes a physical vascular graft and its material properties and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a vascular graft, which is an implantable prosthetic used to replace or bypass a diseased or damaged blood vessel. While it helps manage a condition, its primary function is replacement/bypass, not the direct treatment or cure of a disease process.
No
This device is a vascular graft, which is a prosthetic device used for vascular access, and not a device that diagnoses medical conditions.
No
The device description clearly states it is a "vascular graft," which is a physical implantable device made of ePTFE. The performance studies also focus on physical properties like burst strength, suture pullout, and leak testing, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a vascular prosthesis in patients requiring vascular access." This describes a device that is implanted or used directly on the patient's vascular system for treatment or access, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical graft made of ePTFE with a heparin coating, designed to be a vascular prosthesis. This aligns with a medical device used for surgical or interventional procedures, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is clearly related to providing vascular access in vivo.
N/A
Intended Use / Indications for Use
GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
As determined by the risk analysis, the following testing was performed to demonstrate substantial equivalence to the predicate device:
- Packaging Integrity
- . Packaging shelf-life evaluation
- . Coating performance testing
- . Sterilization testing
- . Dimensional evaluation
- Burst Strength
- . Suture Pullout Strength
- . Tensile Strength
- Water Entry Pressure
- . Kink Radius
- Puncture Burst ●
- . Puncture Leak
- . Suture Line Leak
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
June 23, 2023
W. L. Gore & Associates, Inc. Sarah Pastrnak Regulatory Affairs Associate 1505 N. Fourth Street Flagstaff, Arizona 86004
Re: K231505
Trade/Device Name: GORE® ACUSEAL Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DS Y Dated: May 23, 2023 Received: May 24, 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 (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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 Johnson, Ph.D. 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) K231505
Device Name GORE® ACUSEAL Vascular Graft
Indications for Use (Describe)
GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.
| 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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K231505 510(k) Summary
510(k) Submitter
W. L. Gore & Associates, Inc. 1505 North Fourth St Flagstaff, AZ 86004
Regulatory Contact: Sarah Pastrnak
Phone: 928 864 4146
E-mail: spastrna@wlgore.com
Date Prepared
23 June 2023
Device Names/Classification
Device Name: GORE® ACUSEAL Vascular Graft
Classification Name: Vascular Graft
Regulation: 21 CFR 870.3450
Classification: II
Product Code: DSY
Predicate Devices
K130215, GORE® ACUSEAL Vascular Graft
Device Description
GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.
Indications for Use
GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.
Differences in Technological Characteristics
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The subject and predicate GORE® ACUSEAL Vascular Graft have the same clinical use, indications for use, fundamental technology, materials, sterilization, and same intended use.
The subject GORE® ACUSEAL Vascular Graft permits the use of an additional packaging configuration and additional device configurations with different diameters.
Summary of Performance Testing
As determined by the risk analysis, the following testing was performed to demonstrate substantial equivalence to the predicate device:
- Packaging Integrity
- . Packaging shelf-life evaluation
- . Coating performance testing
- . Sterilization testing
- . Dimensional evaluation
- Burst Strength
- . Suture Pullout Strength
- . Tensile Strength
- Water Entry Pressure
- . Kink Radius
- Puncture Burst ●
- . Puncture Leak
- . Suture Line Leak
Conclusion
The GORE® ACUSEAL Vascular Graft is substantially equivalent to the predicate device. 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.