(85 days)
No
The summary describes a physical vascular graft made of ePTFE and nitinol, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are focused on material properties and in vivo performance, not algorithmic performance.
Yes.
The device is a vascular prosthesis intended for replacement, bypass, or repair of diseased vessels, which makes it a therapeutic device.
No
Explanation: The device description and intended use clearly state that the GORE HYBRID Vascular Graft is a prosthesis used for replacement or bypass of diseased vessels, not for identifying or investigating the nature of a disease.
No
The device description clearly indicates it is a physical vascular graft made of ePTFE and nitinol, not software. The performance studies also focus on physical properties and in vivo performance, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for surgical procedures (vascular replacement, bypass, dialysis access). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a physical implantable device (a vascular graft) made of ePTFE and nitinol. This is consistent with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the graft (burst strength, kink radius, deployment accuracy, etc.) and its performance in an animal model (patency, sealing). These are relevant to an implantable device, not an IVD.
In summary, the GORE HYBRID Vascular Graft is a surgical implant designed to be placed inside the body, not a device used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
The GORE HYBRID Vascular Graft is indicated for use as a vascular prosthesis 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
Device Description
The GORE HYBRID Vascular Graft is an ePTFE vascular prosthesis that has a section reinforced with nitinol The nitinol reinforced section (NRS) is partially constrained to allow for easy insertion and deployment into a vessel to form an end-to-end anastomosis. The constraint is made up of an ePTFE fiber which is knitted into a tubular shape. The GORE HYBRID Vascular Graft with a continuous lumen and has immobilized heparin bonded to the luminal surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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
In Vitro Testing:
Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:
- Wall thickness
- Internal and External Diameter
- Suture Retention (transverse and longitudinal)
- Kink Radius (Pressurized and Non-Pressurized)
- Repeated Punctured Burst
- Burst Testing
- Water Entry Pressure (WEP)
- Tensile Strength
- Constrained Profile
- Deployment Accuracy
- Deployment Force
- Deployment Reliability
- Pre and Post Deployment Dimensional Testing
- Nitinol Reinforced Section (NRS) Flexibility
- Radial Compression Resistance
- Integral Water Permeability
- Fibril Length
- Pressurized Internal Diameter
- Tensile Strength
- Corrosion Testing
- Simulated Device Use
The results from these tests demonstrate that the technological characteristics and performance criteria of the GORE HYBRID Vascular Graft are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
In Vivo Testing:
Study Type: Animal Study (canine model)
Sample Size: Not specified, but involved multiple 3 device attributes.
Key Results: The study evaluated three device attributes: Device Deployment, Device Sealing, and Device Patency.
- Device Deployment: the device can be accurately and easily deployed at the desired location by the surgeon.
- Device Sealing: the device achieves hemostasis successfully post deployment 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. This was assessed visually and via palpation by the surgeon.
The results of this study show that the GORE HYBRID Vascular Graft can be successfully delivered, deployed, remain patent, and maintain position at the intended target location. The device is well tolerated with no deleterious tissue response observed within a normal arteriovenous canine test system.
Key Metrics
Not Found
Predicate Device(s)
K062161, K013648, K071923, K051332
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
L093934
MAR 1 7 2010
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Proprietary Name:
Common Name:
REPUBLIC
HYBRID Vascular Graft
GORE HYBRID Vascular Graft
Classification Name:
Vascular Graft Prosthesis (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 & Associates, Inc. 3250 West Kiltie Lane Flagstaff, AZ 86001-0500
Telephone: (928) 864-3790 Facsimile: (928) 779-4219 E-mail: mivey@wlgore.com
1
510(k) Premarket Notification GORE HYBRID Vascular Graft 510(k) Summary of Substantial Equivalence
Performance Standards
Performance standards do not currently exist for these devices. None are established under Section 514.
Device Description
The GORE HYBRID Vascular Graft is an ePTFE vascular prosthesis that has a section reinforced with nitinol The nitinol reinforced section (NRS) is partially constrained to allow for easy insertion and deployment into a vessel to form an end-to-end anastomosis. The constraint is made up of an ePTFE fiber which is knitted into a tubular shape. The GORE HYBRID Vascular Graft with a continuous lumen and has immobilized heparin bonded to the luminal surface.
Indications for Use
The GORE HYBRID Vascular Graft is indicated for use as a vascular prosthesis 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.
Substantially Equivalent Devices
W.L. Gore & Associates cites the following devices as substantially equivalent predicate devices listed below:
- · GORE PROPATEN® Vascular Graft (K062161) Cleared November 9, 2006
- · GORE VIABAHN® Endoprosthesis (K013648) Cleared January 8, 2002
- · ATRIUM Graduated Wall Flixene Graft (K071923) Cleared August 14, 2007
- · ATRIUM Advanta T-Graft (K051332) Cleared September 29, 2005
Brief Comparison Summary
To demonstrate substantial equivalence of the applicant GORE HYBRID Vascular Graft to the predicate devices, the technological characteristics and performance criterion were evaluated using in vitro and in vivo testing performed in accordance with ISO 7198:1998 "Cardiovascular Implants - Tubular Vascular Prostheses" and ISO 25539-1: 2003 "Cardiovascular Implants - Endovascular Devices" as outlined below:
In Vitro Testing
Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:
2
510(k) Premarket Notification GORE HYBRID Vascular Graft 510(k) Summary of Substantial Equivalence
- Wall thickness .
- � Internal and External Diameter
- Suture Retention . (transverse and longitudinal)
- . Kink Radius (Pressurized and Non-Pressurized)
- Repeated Punctured Burst .
- Burst Testing ●
- Water Entry Pressure (WEP) .
- Tensile Strength
- Constrained Profile .
- Deployment Accuracy ●
- Deployment Force .
- Deployment Reliability
- . Pre and Post Deployment Dimensional Testing
- Nitinol Reinforced Section . (NRS) Flexibility
- . Radial Compression Resistance
- Integral Water Permeability .
- Fibril Length .
- Pressurized Internal Diameter .
- Tensile Strength .
- Corrosion Testing .
- Simulated Device Use .
The results from these tests demonstrate that the technological characteristics and performance criteria of the GORE HYBRID Vascular Graft are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
In Vivo Testing
To assess the performance of the GORE HYBRID 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 3 device attributes:
- Device Deployment: the device can be accurately and easily deployed at the . desired location by the surgeon.
- Device Sealing: the device achieves hemostasis successfully post deployment . 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. This was assessed visually and via palpation by the surgeon.
The results of this study show that the GORE HYBRID Vascular Graft can be successfully delivered, deployed, remain patent, and maintain position at the intended target location. The device is well tolerated with no deleterious tissue response observed within a normal arteriovenous canine test system.
Conclusion (Statement of Equivalence)
W.L. Gore & Associates Inc. believes that the data and information presented in this application, including in vitro testing, in vivo animal data, and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the GORE HYBRID Vascular Graft through this 510(k) Premarket Notification
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
W.L. Gore & Associates, Inc. c/o Mr. Michael Ivey Regulatory Affairs Medical Products Division 3250 Kiltie Lane P. O. Box 2400 Flagstaff, AZ 86001
MAR 1 7 2010
Re: K093934
GORE HYBRID Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: December 18, 2009 Received: December 22, 2009
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.
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.
4
Page 2 - Mr. Michael Ivev
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 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/CDRHQffices/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" (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/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,
era R. Vidmer
Image /page/4/Picture/7 description: The image shows a black and white drawing of a stylized letter 'f'. The letter is drawn in a cursive style, with a loop at the top and a curved line extending downwards. The lines are thick and bold, giving the letter a strong presence. The background is plain white, which makes the letter stand out.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification GORE HYBRID Vascular Graft Indication For Use
INDICATION FOR USE
| 510(k) Number (if known): | TBD
K093934 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GORE HYBRID Vascular Graft |
| Intended Use / Indication For Use: | The GORE HYBRID Vascular Graft is indicated for use as a vascular prosthesis 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
sunn R.V.V.V
(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
510(k) Number Kory 3 7 3 4
Image /page/5/Picture/11 description: The image contains the Gore logo on the left side. The logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the logo, there is some smaller text that is difficult to read. To the right of the logo, the word "Confidential" is written in a simple, sans-serif font. The text is horizontally aligned.