(183 days)
The MEADOX® ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide 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. Externally Supported Grafts are used where kinking and compression resistance are desired.
The ePTFESSENDOS, Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
The provided text describes a medical device, the Meadox Medicals, Inc., Expanded Reinforced PTFE Vascular Graft, and its characteristics, rather than an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including details like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.
The document focuses on:
- Device Description: Material composition (ePTFE core with PTFE yarn reinforcement, optional external support coil).
- Biocompatibility Testing: Demonstrates the device passed various tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity/Mutagenicity, Implantation, Hemocompatibility, Chronic Toxicity) in accordance with ISO-10993 standards.
- Predicate Devices: Lists similar commercially available devices to establish substantial equivalence.
- Performance Specifications: States that the device's performance specifications (e.g., Internodal Distance, Water Entry Pressure, Tensile Strengths, Burst Strength, Suture Retention, Kink Diameter, Crush Resistance) are "Equivalent to marketed products" (predicate devices).
Therefore, I cannot extract the requested information as it pertains to AI/ML device evaluation, which is not described in this document.
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| GENERAL INFO: Sponsor - | Meadox Medicals, Inc | MAY 30 1996 |
|---|---|---|
| Contact Person - | Stephen B Anderson | |
| Submission Date - | November 22, 1995 | |
| DEVICE INFO: Generic Name - | Expanded Reinforced PTFE Vascular Graft | |
| Trade Name - | Meadox Medicals, Inc , Expanded PTFE Vascular GraftMeadox Medicals, Inc , Expanded PTFE Vascular Graft w/External Support | |
| Classification Name - | Vascular Graft Prosthesis (6 mm and greater) |
Classification Name - Vascular Graft Prosthesis (6 mm and greater)
PREDICATE DEVICES:
| K-Number | Proprietary Name | Company |
|---|---|---|
| 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. |
ורייניי
DEVICE DESCRIPTION: The ePTFESSENDOS, Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
Biocompatibility testing on the ePTFESSEADS: Vascular Graft was performed on single-BIOCOMPATIBILITY: cycle steam sterilized grafts in accordance with the ISO-10993 standard for biological evaluation of medical devices. Carcmogenicity testing was not performed on ePTFESSEADOX grafts due to the established nontoxic properties of the graft materials. These tests indicate that the ePTFE str \box Vascular Graft is safe for its intended use
| Cytotoxicity - | Passed |
|---|---|
| Sensitization - | Passed |
| Irritation orIntracutaneous Reactivity - | Passed |
| Systemic Toxicity (acute) - | Passed |
| Sub-chronic Toxicity (sub-acute)- | Passed |
| Genotoxicity/Mutagenicity - | Passed |
| Implantation - | Passed |
| Hemocompatibility (hemolysis)- | Passed |
| Chronic Toxicity - | Passed |
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SUMMARY OF SAFETY & EFFECTIVENESS
| INDICATIONS: | The MEADOX® ePTFE Vascular Grafts are designed to repair or replace peripheralarteries and to provide vascular access. Mid-Flex grafts are specifically indicated forvascular access, as are Stepped grafts which are designed to reduce the risk of stealsyndrome. Externally Supported Grafts are used where kinking and compressionresistance are desired. | |||||
|---|---|---|---|---|---|---|
| DESIGN MATERIALS: | Design materials of the ePTFEMEADOX Vascular Graft are substantially equivalent to thepredicate devices identified above. | |||||
| MANUFACTURING: | The ePTFEMEADOX Vascular Graft is produced by heating, stretching and winding anextruded polytetrafluoroethylene tube. | |||||
| SPECIFICATIONS: | Performance specifications of the ePTFEMEADOX Vascular Graft are substantiallyequivalent to the range of performance specifications found in the previously identifiedpredicate devices. | |||||
| Internodal Distance -Water Entry Pressure -Radial Tensile Strength -Longitudinal Tensile Strength -Burst Strength -Suture Retention Strength (Longitudinal) -Suture Retention Strength (Oblique) -Suture Hole Elongation -Kink Diameter -Crush Resistance -Burst After Repeated Puncture ( 12 months) -Burst After Repeated Puncture ( 18 months) -Relaxed Internal Diameter -Usable Length -Nominal Wall Thickness - | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | |
| Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | ||
| Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products | Equivalent to marketed products |
The Meadox Medicals, Inc., Vascular Graft has a level of safety and effectiveness CONCLUSION: comparable to currently marketed ePTFE Vascular Grafts.
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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.”