K Number
K955532
Device Name
DIASTAT VASCULAR ACCESS GRAFT
Date Cleared
1996-03-11

(97 days)

Product Code
Regulation Number
870.3450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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
Device Description
The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation seqments 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.
More Information

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Not Found

No
The summary describes a physical vascular graft and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is a vascular prosthesis intended for use in patients requiring vascular access, which aims to treat or manage a medical condition (need for vascular access) and has demonstrated performance characteristics like reduced fluid leakage and blood loss, positioning it as a therapeutic intervention.

No

Explanation: The device is described as a vascular prosthesis (graft) intended for vascular access, and its performance studies focus on mechanical properties and outcomes like reduced bleeding and hematoma, not on detecting, diagnosing, or monitoring a disease or condition.

No

The device description clearly outlines a physical, implantable vascular graft made of expanded PTFE with external components. It is a hardware device, not software.

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 augment a blood vessel.
  • Device Description: The description details a physical implant made of expanded PTFE, designed to be surgically placed.
  • Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
  • Performance Studies: The performance studies focus on mechanical properties, in vivo performance (hemostasis, blood loss, hematoma), and clinical observations related to implantation and cannulation. These are typical evaluations for an implantable medical device, not an IVD.

Therefore, the DIASTAT® VASCULAR ACCESS GRAFT is a surgical implant, not an in vitro diagnostic device.

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 seqments 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

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Vascular

Indicated Patient Age Range

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Intended User / Care Setting

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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

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 testing, 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

Not Found

Predicate Device(s)

DIASTAT Vascular Access Grafts, GORE-TEX® Vascular Grafts, Atrium Plasma TFE™ Vascular Graft

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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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TAB E K955532

SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED

1

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 6 mm and greater 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 testing, 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 seqments 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 prober 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