(387 days)
The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.
The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
This document is a Premarket Notification (510(k)) for a medical device submitted in 1996. It does not describe a study involving an AI/Machine Learning device or software, nor does it contain acceptance criteria or performance data in the context of such studies.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device (ePTFE Vascular Graft) to predicate devices already on the market, based on material, manufacturing, and general performance specifications.
{0}------------------------------------------------
PREMARKET NOTIFICATION Meadox Medicals Inc ePTFF Vascular Grafts 3 - 5mm Friday, February 23, 1996
PREDI
MAR 19 1997
SUMMARY OF SAFETY & ENFECTIVE
| GENERAL INFO: Sponsor - | Meadox Medicals, Inc. |
|---|---|
| Contact Person - | Stephen B Anderson |
| Submission Date - | February 23, 1996 |
| DEVICE INFO: Generic Name - | Expanded Reinforced PTFE Vascular Graft |
|---|---|
| Trade Name - | Meadox Medicals, Inc., Expanded PTFE Vascular Graft Meadox Medicals, Inc., Expanded PTFE Vascular Graft w/External Support |
Classification Name - Vascular Graft Prosthesis (less than 6 mm)
| K-Number | Proprietary Name | Company |
|---|---|---|
| Preamendment | GORE-TEX® Vascular Graft | W.L. Gore & Associates |
| Preamendment | IMPRA® Vascular Graft | IMPRA, Inc. |
| K79 1810 | IMPRA® Vascular Graft | IMPRA, Inc. |
| K81 1510 | GORE-TEX® FEP Ringed Vascular Graft | W.L. Gore & Associates |
| K82 1716 | Bard® PTFE Vascular Prosthesis | C.R. Bard, Incorporated |
| K83 0806 | GORE-TEX® Vascular Graft | W.L. Gore & Associates |
| K84 2144 | GORE-TEX® Stretch Vascular Graft | W.L. Gore & Associates |
| K88 0167 | GORE-TEX® Removable FEP Ring Graft | W.L. Gore & Associates |
| K93 3590 | Baxter Reinforced Expanded PTFE Graft | Baxter Healthcare, Corp. |
DEVICE DESCRIPTION: The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
Vascular Graft was performed on single-Biocompatibility testing on the ePTF MEADOX Vascular Graft was performed on sugle BIOCOMPATIBILITY: evaluation of medical devices. Carcinogenicity testing was not performed on These tests indicate that the ePTFE MEADOx Vascular Graft is safe for its intended use.
The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular INDICATIONS: --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.
Design materials of the ePTFEMEADS: Vascular Graft are substantially equivalent to the DESIGN MATERIALS: predicate devices identified above.
The ePTFEMEADOx Vascular Graft is personal is profit is p Vascular Graft is produced by heating, stretching and winding an MANUFACTURING:
SPECIFICATIONS: Performance specifications of the ePTFEMEADX Vascular Graft are substantially
equivalent to the range of performance specifications found in the previously identified predicate devices.
CONCLUSION: The Meadox Medicals, Inc., Vascular Graft has a level of safety and effectiveness comparable to currently marketed ePTFE Vascular Grafts.
§ 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.”