(90 days)
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No
The device description and performance studies focus on the material properties and physical performance of a vascular graft, with no mention of AI or ML technologies.
Yes
The device is a vascular graft indicated for repair or replacement of damaged and diseased vessels, which is a therapeutic intervention.
No
The device is a vascular graft, an implantable prosthetic used for repairing or replacing blood vessels, not for diagnosing diseases.
No
The device description clearly states it is a gelatin-sealed, woven polyester graft, which is a physical hardware component, 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 for the "repair or replacement of damaged and diseased vessels of the abdomen." This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a "vascular graft," which is an implantable medical device used to replace or bypass blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a therapeutic implant used directly within the body.
N/A
Intended Use / Indications for Use
The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Product codes
Not Found
Device Description
The Gelweave™ vascular graft (bifurcated configuration) is a gelatin-sealed, woven polyester graft, with a base graft porosity of 350 ml/min/om2. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. This gelatin has been shown to be safe and effective through the approval of PMA# P890045 on January 11, 1993.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
abdomen
Indicated Patient Age Range
Not Found
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
Side-by-side in-vitro performance testing has been performed on the Vascutek Gelweave™ straight and bifurcated vascular grafts. In-vitro performance testing performed on the Gelweave™ including burst strength, suture retention, tensile strength and base graft (water) porosity provides evidence that the Gelweave™ vascular graft (bifurcated configuration) is substantially equivalent to the straight configuration. Animal testing has demonstrated acceptable in-vivo performance for the Gelweave™ graft's intended purpose.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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
Image /page/0/Picture/0 description: The image shows the logo for CarboMedics, a company of Sulzer Medica. The logo features a black hexagon shape on the left, followed by the company name in a bold, stylized font. Below the company name, in a smaller font, is the text "A company of SULZERmedica."
1300 EAST ANDERSON LANE, AUSTIN, TEXAS 78752-1793
FEB | 9 1997
510(k) SUMMARY
VASCUTEK GELWEAVE™ VASCULAR GRAFT (BIFURCATED CONFIGURATION)
The Gelweave™ vascular graft (bifurcated configuration) is a gelatin-sealed, woven polyester graft, with a base graft porosity of 350 ml/min/om2. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. This gelatin has been shown to be safe and effective through the approval of PMA# P890045 on January 11, 1993.
The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
The Gelweave™ vascular graft (bifurcated configuration) is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. This polyester material and gelatin sealant have been thoroughly tested and characterized with regard to biocompatibility and suitability for their intended use. The Gelweave™ vascular graft is supplied sterile. The method of sterilization used is Ethylene Oxide. A shelf-life of 4 years has been established for the Vascutek Gelweave™ vascular graft.
CarboMedics considers the Vascutek Gelweave™ vascular graft (bifurcated configuration) to be substantially equivalent to the Vascutek Gelweave™ vascular graft (straight configuration) in intended use, composition, and function. Side-by-side in-vitro performance testing has been performed on the Vascutek Gelweave™ straight and bifurcated vascular grafts. In-vitro performance testing performed on the Gelweave™ including burst strength, suture retention, tensile strength and base graft (water) porosity provides evidence that the Gelweave™ vascular graft (bifurcated configuration) is substantially equivalent to the straight configuration. Animal testing has demonstrated acceptable in-vivo performance for the Gelweave™ graft's intended purpose.
CarboMedics considers the Vascutek Gelweave™ vascular graft (bifurcated configuration) safe, effective, and substantially equivalent in intended use, composition, and function to the straight configuration 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 Gelweave™ vascular graft |
| (bifurcated configuration) | |
| 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: | November 20, 1996 |
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