(64 days)
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No
The summary describes a physical vascular graft and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for "systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries," which is a therapeutic intervention.
No
Explanation: The device is described as a vascular graft for systemic vascular repair, such as replacement or bypass in aneurysmal and occlusive arterial disease. This indicates it is a therapeutic or reparative device, not one used for diagnosis.
No
The device description clearly states it is a "warp knitted polyester prosthesis," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Vascusoft™ Plus Vascular Graft is a physical implantable device (a polyester prosthesis) used for surgical repair of blood vessels within the body. It is not used to analyze samples taken from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.
Product codes
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Device Description
The Vascusoft™ Plus Vascular Graft is a warp knitted polyester prosthesis with a porosity of 2591 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Vascusoft™ Plus vascular graft is manufactured from material that has an extensive history of use in cardiovascular and other medical applications. This polyester material has been thoroughly tested and characterized with regard to biocompatibility and suitability for its intended use. The Vascusoft™ Plus vascular graft is supplied sterile and must be preclotted prior to use. The method of sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established for the Vascutek Vascusoft™ Plus vascular graft.
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
systemic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comprehensive performance testing has been performed on the Vascutek Vascusoft™ Plus Vascular Graft, which includes in-vitro and animal evaluations. In-vitro performance testing performed on both the Vascusoft™ Plus and the Vascusoft™ vascular graft, which includes burst strength, suture retention, tensile strength and water permeability provides evidence that the Vascusoft™ "Plus" vascular graft is substantially equivalent to the Vascusoft™ vascular graft and has shown enhanced resistance to dilatation in in-vitro studies. Animal testing has demonstrated acceptable in-vivo performance for the Vascusoft™ Plus graft's intended purpose.
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.
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.
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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).
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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.”
0
Image /page/0/Picture/0 description: The image shows the logo for CarboMedics, a company of Sulzer Medica. Below the logo is the address 1300 East Anderson Lane, Austin, Texas 78752-1793. The CarboMedics logo features a hexagon shape with lines inside and the company name in a stylized font.
APR 2 5 1996
510(k) SUMMARY VASCUTEK VASCUSOFT™ PLUS VASCULAR GRAFT
The Vascusoft™ Plus Vascular Graft is a warp knitted polyester prosthesis with a porosity of 2591 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.
The Vascusoft™ Plus vascular graft is manufactured from material that has an extensive history of use in cardiovascular and other medical applications. This polyester material has been thoroughly tested and characterized with regard to biocompatibility and suitability for its intended use. The Vascusoft™ Plus vascular graft is supplied sterile and must be preclotted prior to use. The method of sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established for the Vascutek Vascusoft™ Plus vascular graft.
Comprehensive performance testing has been performed on the Vascutek Vascusoft™ Plus Vascular Graft, which includes in-vitro and animal evaluations. In-vitro performance testing performed on both the Vascusoft™ Plus and the Vascusoft™ vascular graft, which includes burst strength, suture retention, tensile strength and water permeability provides evidence that the Vascusoft™ "Plus" vascular graft is substantially equivalent to the Vascusoft™ vascular graft and has shown enhanced resistance to dilatation in in-vitro studies. Animal testing has demonstrated acceptable in-vivo performance for the Vascusoft™ Plus graft's intended purpose.
CarboMedics considers the Vascutek Vascusoft™ Plus Vascular Graft safe, effective and substantially equivalent in intended use, material (polyester), and function to the Vascutek Vascusoft™ Vascular Graft, which received 510(k) marketing clearance under K830016/F, later reassigned 510(k) number K910866 on April 1, 1991.