(162 days)
DIASTAT Vascular Access Grafts, GORE-TEX® Vascular Grafts, Atrium Plasma TFE™ Vascular Graft
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No
The description focuses on the material and structural properties of the graft, with no mention of AI or ML.
Yes
The device is a vascular graft, which is a common therapeutic intervention to provide vascular access for patients.
No
Explanation: The device is a vascular graft, which is a prosthetic used for vascular access, and its function involves implantation and cannulation, not diagnosis.
No
The device description clearly describes a physical vascular graft made of expanded PTFE with external components, indicating it is a hardware medical 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 into the body to replace or repair a blood vessel.
- Device Description: The description details a physical graft made of expanded PTFE, designed for implantation and cannulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment. The device itself is the treatment/access point.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a medical implant.
N/A
Intended Use / Indications for Use
The DIASTAT® Vascular Access Graft, intended for use as a vascular prosthesis in patients requiring vascular access, and which may be cannulated within one week of implantation
Product codes
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Device Description
The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation segments comprised of expanded PTFE fibers and an expanded PTFE covering. The graft is provided with or without external reinforcement in the form of FEP rings which may be fixed or removable, and in either extensible or non-stretch configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantially equivalent performance is demonstrated by a variety of mechanical and nonclinical in vivo tests. Reduced fluid leakage was demonstrated in bench testing using water, a liquid more likely to leak than heparinized blood. Animal testing confirmed this performance characteristic, with reduced times to hemostasis and reduced blood loss in vivo, and also demonstrated reduced incidence of hematoma. A prospective randomized clinical study of early cannulation of the DIASTAT Vascular Access Graft was not performed. The DIASTAT Vascular Access Graft possesses a specific mechanical low bleed feature which has been characterized in bench tested in vivo. and observed in the clinical setting. These characterizations, tests, and observations confirm that the DIASTAT Vascular Access Graft is substantially equivalent to the Plasma TFE Vascular Graft for cannulation within one week of implantation, and that the DIASTAT Vascular Access Graft does not raise any new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
DIASTAT Vascular Access Grafts, GORE-TEX® Vascular Grafts, Atrium Plasma TFE™ Vascular Graft
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
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
P.57
K955533
TAB E
MAY 1 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED
510(k) SUBMITTER:
| NAME: | W.L. Gore & Associates Inc. |
|---|---|
| ADDRESS: | 1505 N. Fourth Street |
| P.O. Box 2200 | |
| Flagstaff, AZ 86003-2200 |
CONTACT PERSON:
Timothy J. Rynn W.L. Gore & Associates, Inc. 1505 N. Fourth Street P.O. Box 2200 Flagstaff, AZ 86003-2200 (520)526-3030 FAX (520) 526-3815
Date Summary Prepared: November 13, 1995
DEVICE NAME:
CLASSIFICATION NAME: Vascular Graft Prosthesis less than 6 mm diameter COMMON/USUAL NAME: Vascular Graft TRADE/PROPRIETARY NAME: DIASTAT® VASCULAR ACCESS GRAFT
The DIASTAT Vascular Access Graft, intended for use as a vascular prosthesis in patients requiring vascular access, and which may be cannulated within one week of implantation, is substantially equivalent to various configurations of legally marketed predicate DIASTAT Vascular Access Grafts, various configurations of GORE-TEX® Vascular Grafts and the Atrium Plasma TFE™ Vascular Graft. DIASTAT Vascular Access Grafts are subject to the same general Quality Assurance systems and controls as GORE-TEX Vascular Grafts.
Substantially equivalent performance is demonstrated by a variety of mechanical and nonclinical in vivo tests. Reduced fluid leakage was demonstrated in bench testing using water, a liquid more likely to leak than heparinized blood. Animal testing confirmed this performance characteristic, with reduced times to hemostasis and reduced blood loss in vivo, and also demonstrated reduced incidence of hematoma.
Early cannulation techniques, including poor aseptic practice, and cannulation into swollen tissue, may tend to increase the risk of infection and thereby affect graft patency. These risks are addressed in the proposed labeling changes emphasizing strict aseptic technique for early cannulations.
1
TAB E SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED
A prospective randomized clinical study of early cannulation of the DIASTAT Vascular Access Graft was not performed. The DIASTAT Vascular Access Graft possesses a specific mechanical low bleed feature which has been characterized in bench tested in vivo. and observed in the clinical setting. These characterizations, tests, and observations confirm that the DIASTAT Vascular Access Graft is substantially equivalent to the Plasma TFE Vascular Graft for cannulation within one week of implantation, and that the DIASTAT Vascular Access Graft does not raise any new issues of safety and effectiveness.
The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation segments comprised of expanded PTFE fibers and an expanded PTFE covering. The graft is provided with or without external reinforcement in the form of FEP rings which may be fixed or removable, and in either extensible or non-stretch configurations. A comparison of the technological characteristics of the DIASTAT Vascular Access Graft and predicate devices reveals that no new types of safety and effectiveness questions are raised. No new biocompatibility or blood-contact issues are presented by the DIASTAT Vascular Access Graft.
The claims, labeling, and intended use of the DIASTAT Vascular Access Graft are substantially equivalent to those for the predicate DIASTAT Vascular Access Graft, all other GORE-TEX Vascular Grafts, and the Plasma TFE Vascular Graft. They have been modified only as necessary to accurately describe the product and to ensure that adequate and proper instructions for use as a vascular access prosthesis are provided.
*GORE-TEX and DIASTAT are registered trademarks of W.L. Gore & Associates, Inc. "Plasma TFE is a trademark of Atrium Medical Corporation