Predicate Devices

K79 1810, K81 1510, K82 1716, K83 0806, K84 2144, K88 0167, K93 3590

Reference Devices

K79 1810, K81 1510, K82 1716, K83 0806, K84 2144, K88 0167, K93 3590

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical vascular graft made of ePTFE and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

Therapeutic

Yes
The device is designed to repair or replace peripheral arteries and provide vascular access, which are therapeutic interventions.

Diagnostic

No

The device is a vascular graft designed to repair or replace peripheral arteries and provide vascular access, which indicates a therapeutic or restorative function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is comprised of a physical ePTFE core tube and reinforcing yarn, and in some cases, a PTFE spiral support coil. This indicates a physical, implantable device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is designed to "repair or replace peripheral arteries and to provide vascular access." This is a surgical/implantable device used directly within the body.
Device Description: The description details a physical graft made of ePTFE, designed to be implanted.
Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
Performance Studies: The performance studies focus on biocompatibility and physical performance, not diagnostic accuracy or analytical performance, which are typical for IVDs.

This device is a surgical implant used for vascular repair and access.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

Not Found

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. The ePTFEMEADOX Vascular Graft is produced by heating, stretching and winding an extruded polytetrafluoroethylene tube.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral arteries

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 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

Key Metrics

Cytotoxicity - Passed
Sensitization - Passed
Irritation or Intracutaneous Reactivity - Passed
Systemic Toxicity (acute) - Passed
Sub-chronic Toxicity (sub-acute) - Passed
Genotoxicity/Mutagenicity - Passed
Implantation - Passed
Hemocompatibility (hemolysis) - Passed
Chronic Toxicity - Passed
Internodal Distance - Equivalent to marketed products
Water Entry Pressure - Equivalent to marketed products
Radial Tensile Strength - Equivalent to marketed products
Longitudinal Tensile Strength - Equivalent to marketed products
Burst Strength - Equivalent to marketed products
Suture Retention Strength (Longitudinal) - Equivalent to marketed products
Suture Retention Strength (Oblique) - Equivalent to marketed products
Suture Hole Elongation - Equivalent to marketed products
Kink Diameter - Equivalent to marketed products
Crush Resistance - Equivalent to marketed products
Burst After Repeated Puncture ( 12 months) - Equivalent to marketed products
Burst After Repeated Puncture ( 18 months) - Equivalent to marketed products
Relaxed Internal Diameter - Equivalent to marketed products
Usable Length - Equivalent to marketed products
Nominal Wall Thickness - Equivalent to marketed products

Predicate Device(s)

K79 1810, K81 1510, K82 1716, K83 0806, K84 2144, K88 0167, K93 3590

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.”

Summary

0

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 Graft
Meadox 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 or
Intracutaneous Reactivity -	Passed
Systemic Toxicity (acute) -	Passed
Sub-chronic Toxicity (sub-acute)-	Passed
Genotoxicity/Mutagenicity -	Passed
Implantation -	Passed
Hemocompatibility (hemolysis)-	Passed
Chronic Toxicity -	Passed

010

1

SUMMARY OF SAFETY & EFFECTIVENESS

| INDICATIONS: | 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. | | | | | |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|
| DESIGN MATERIALS: | Design materials of the ePTFEMEADOX Vascular Graft are substantially equivalent to the
predicate devices identified above. | | | | | |
| MANUFACTURING: | The ePTFEMEADOX Vascular Graft is produced by heating, stretching and winding an
extruded polytetrafluoroethylene tube. | | | | | |
| SPECIFICATIONS: | Performance specifications of the ePTFEMEADOX Vascular Graft are substantially
equivalent to the range of performance specifications found in the previously identified
predicate 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.

: