(387 days)
K79 1810, K81 1510, K82 1716, K83 0806, K84 2144, K88 0167, K93 3590
K79 1810, K81 1510, K82 1716, K83 0806, K84 2144, K88 0167, K93 3590
No
The summary describes a physical vascular graft made of ePTFE and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vascular graft designed for vascular access, implying it is used to treat or manage a medical condition, which is a therapeutic function.
No
The device description and intended use clearly state that this is a vascular graft, which is an implantable medical device used for vascular access, not for diagnosing medical conditions.
No
The device description clearly states it is a physical vascular graft made of expanded PTFE, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "vascular access," which is a surgical procedure performed directly on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The device is a vascular graft, a physical implant used to create a pathway for blood flow. This is a medical device, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing on the ePTF MEADOx Vascular Graft was performed on sugle 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.
Key Metrics
Not Found
Predicate Device(s)
Preamendment GORE-TEX® Vascular Graft, Preamendment IMPRA® Vascular Graft, K79 1810 IMPRA® Vascular Graft, K81 1510 GORE-TEX® FEP Ringed Vascular Graft, K82 1716 Bard® PTFE Vascular Prosthesis, K83 0806 GORE-TEX® Vascular Graft, K84 2144 GORE-TEX® Stretch Vascular Graft, K88 0167 GORE-TEX® Removable FEP Ring Graft, K93 3590 Baxter Reinforced Expanded PTFE Graft
Reference Device(s)
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
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.