(89 days)
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No
The summary describes a physical vascular graft and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for "repair or replacement of damaged and diseased vessels," which describes a therapeutic function.
No
The device is a vascular graft, an implantable device used for repair or replacement of vessels, not for diagnosing conditions.
No
The device description clearly states it is a "woven polyester graft," which is a physical hardware component, not software. The performance studies also focus on physical properties like burst strength and suture retention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair or replacement of damaged and diseased vessels within the arterial system. This is a surgical implant used directly within the body.
- Device Description: The device is a woven polyester graft, a physical implant.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such diagnostic testing on specimens.
The performance studies mentioned are in-vitro (meaning "in glass" or outside the body, often in a lab setting) and in-vivo (meaning "in living" or within an animal model), but these are tests of the device's physical properties and performance as an implant, not diagnostic tests on patient specimens.
N/A
Intended Use / Indications for Use
The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.
Product codes
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Device Description
The Twillweave™ vascular graft is a woven polyester graft, with a porosity of 350 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Twillweave™ vascular graft is manufactured from materials that have 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 Twillweave™ 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 Twillweave™ 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
arterial system
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
Side-by-side in-vitro performance testing has been performed on the Vascutek Twillweave™ straight and bifurcated vascular grafts and the predicate device. In-vitro performance testing performed on the Twillweave™ including burst strength, suture retention, tensile strength and base graft (water) provides evidence that the Twillweave™ vascular graft is substantially equivalent to the Vascutek Gelweave™ vascular graft. Animal testing has demonstrated acceptable in-vivo performance for the Twillweave™ graft's intended purpose.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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.”
0
Image /page/0/Picture/0 description: The image shows the logo for CarboMedics. The logo consists of a black hexagon shape on the left, followed by the company name in a bold, sans-serif font. There is a small registered trademark symbol to the upper right of the company name.
1300 East Anderson Lane, Austin, Texas 78752-1793 ♥ 512 435 3200 ♥ 512 435 3350 FAX
ત્ત્વપૂર્વ વિદ્યા
510(k) SUMMARY VASCUTEK TWILLWEAVE™ VASCULAR GRAFT
MAR 1 0 1997
The Twillweave™ vascular graft is a woven polyester graft, with a porosity of 350 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.
The Twillweave™ vascular graft is manufactured from materials that have 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 Twillweave™ 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 Twillweave™ vascular graft.
CarboMedics considers the Vascutek Twillweave™ vascular graft to be substantially equivalent to the Vascutek Gelweave™ vascular graft in intended use, base material (polyester), and function. Side-by-side in-vitro performance testing has been performed on the Vascutek Twillweave™ straight and bifurcated vascular grafts and the predicate device. Invitro performance testing performed on the Twillweave™ including burst strength, suture retention, tensile strength and base graft (water) provides evidence that the Twillweave™ vascular graft is substantially equivalent to the Vascutek Gelweave™ vascular graft. Animal testing has demonstrated acceptable in-vivo performance for the Twillweave™ graft's intended purpose.
CarboMedics considers the Vascutek Twillweave™ vascular graft safe, effective, and substantially equivalent in intended use, base material (polyester), and function to the Vascutek Gelweave™ vascular graft which received marketing clearance on December 19, 1995 510(k) via K952293.
| Common name of the device: | Prosthesis, Vascular Graft |
|---|---|
| Trade or Proprietary name: | Vascutek Twillweave™ vascular graft |
| Submitter and Contact name: | Teena M. Augostino, Manager, Regulatory Affairs |
| 1300 E. Anderson Lane, Austin, TX 78752 | |
| Phone: (512) 435-3225 | |
| Fax: (512) 435-3350 |
Submission Prepared/Submitted on: December 10, 1996.
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