(73 days)
Not Found
Not Found
No
The device description and performance studies focus on the material composition and clinical outcomes of a vascular graft, with no mention of AI or ML technologies.
Yes.
Vascular grafts are used to restore blood flow in diseased or damaged vessels, thereby treating a medical condition.
No
Explanation: The device is described as a vascular prosthesis used for surgical implantation, not for diagnosing medical conditions. It is intended to replace or bypass diseased blood vessels.
No
The device description clearly states it is a physical vascular graft made of ePTFE and carbon particles, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as vascular prostheses," which are implanted devices used to replace or bypass blood vessels. This is a surgical/implantable device, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the materials and manufacturing of an implantable graft. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies focus on the patency and safety of the implanted graft in patients, which are clinical outcomes, not diagnostic test performance metrics.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
IMPRA Carboflo™ ePTFE Vascular Grafts are intended for use as vascular prostheses.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
IMPRA Carboflo™ ePTFE Vascular Grafts are made primarily of expanded polytetrafluoroethylene (ePTFE) using the same manufacturing procedures that are used to manufacture IMPRA ePTFE Vascular Grafts, the devices to which substantial equivalence is claimed. The region of the graft wall adjacent to the lumen, approximately 20-25% of the total wall thickness, is uniformly impregnated with Carbon particles along the entire length of the carbon impregnated region is formed integral to the outer region of the wall by mixing the PTFE resin mixed with carbon particles, with the non-carbon containing PTFE resin during a singular extrusion process, which results in a monolithic graft wall. The carbon used in the device is USP grade activated charcoal. All other components of the Carboflo graft, namely PTFE, lubricant used as a manufacturing aid, blue pigment incorporated in the orientation lines, and the external support PTFE beading are the same as those used in the manufacture of the predicate devices. These grafts are supplied in the same product configurations as the predicate device, and are packaged, labeled, and sterilized in the same manner as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower extremity
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center, prospective, randomized clinical trial comparing IMPRA Carboflo™ ePTFE Vascular Grafts to commercially available ePTFE Vascular Grafts, was performed in France between 1990-1994. The purpose of the investigation was to compare the patencies of both IMPRA Carboflo ePTFE Vascular Grafts and Standard ePTFE Vascular Grafts. A total of 81 patients received Carboflo grafts and 79 received Standard ePTFE grafts. All grafts were implanted to treat lower extremity vascular disease. Of the 160 grafts, only 5 grafts (3 Carboflo, 2 Standard) were considered to be Above-Knee, and the remaining grafts were all Below-Knee.
73% of the distal anastomoses were direct graft to vessel, with the following types comprising the other anastomoses: venous patch (16%), distal arterio-venous fistula (5.8%), or interpositional vein cuff graft (5.2%). All implanted grafts were followed for at least 24 months, or until failure, lost to follow-up, or death of patient. Adverse events were recorded and documented on Case Report Forms (CRF).
PRIMARY PATENCY was defined as the time between implant date and date of follow-up when the graft was patent, prior to the first intervention to correct complications. Interventions included immediate re-operations to correct any complication post implantation. SECONDARY PATENCY was defined as the time between implant date and date on which the graft is no longer patent or useful, after a series of interventions. Conventional life-tables were then constructed to determine the Cumulative Primary and Secondary Patencies. At the end of the 2 yr follow-up, patencies were as follows:
Cumulative Primary Patency for Carboflo grafts was 36.8 % compared to 27.7% for Standard grafts at the end of 24 months.
Cumulative Secondary Patency for Carboflo grafts was 42.7% compared to 32.3% for Standard grafts.
These results are not statistically significantly different at p=0.05.
DEVICE SAFETY was demonstrated by determining adverse events for both Carboflo and Standard grafts. Complications were counted as they were encountered and added up at the end of the study period for each patient.
No new type of complications were identified with Carboflo grafts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cumulative Primary Patency for Carboflo grafts was 36.8 % compared to 27.7% for Standard grafts at the end of 24 months.
Cumulative Secondary Patency for Carboflo grafts was 42.7% compared to 32.3% for Standard grafts.
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.
IMPRA ePTFE Vascular Graft
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN -2 1997 K964197
Summary of Safety and Effectiveness for IMPRA Carboflo™ ePTFE Vascular Graft
SUBMITTER
Rajagopal R. Kowligi, Ph.D Manager, Clinical Affairs IMPRA, A Division of C.R. Bard, Inc. 1625 West Third Street Tempe, AZ 85281
DATE SUMMARY WAS PREPARED
October 18, 1996
NAME OF THE DEVICE
IMPRA Carboflo™ ePTFE Vascular Graft
IDENTIFICATION OF PREDICATE DEVICE
IMPRA ePTFE Vascular Graft
DESCRIPTION OF THE DEVICE
..............................................................................................................................................................................
IMPRA Carboflo™ ePTFE Vascular Grafts are made primarily of expanded polytetrafluoroethylene (ePTFE) using the same manufacturing procedures that are used to manufacture IMPRA ePTFE Vascular Grafts, the devices to which substantial equivalence is claimed. The region of the graft wall adjacent to the lumen, approximately 20-25% of the total wall thickness, is uniformly impregnated with Carbon particles along the entire length of the carbon impregnated region is formed integral to the outer region of the wall by mixing the PTFE resin mixed with carbon particles, with the non-carbon containing PTFE resin during a singular extrusion process, which results in a monolithic graft wall. The carbon used in the device is USP grade activated charcoal. All other components of the Carboflo graft, namely PTFE, lubricant used as a manufacturing aid, blue pigment incorporated in the orientation lines, and the external support PTFE beading are the same as those used in the manufacture of the predicate devices. These grafts are supplied in the same product configurations as the predicate device, and are packaged, labeled, and sterilized in the same manner as the predicate devices.
Extensive bench testing and microscopic analysis has shown that the carbon
1
particles are an integral part of the wall and cannot be separated. The amount of carbon incorporated in each Carboflo vascular graft is less than 1% of the total weight of the graft.
INTENDED USE
IMPRA Carboflo™ ePTFE Vascular Grafts are intended for use as vascular prostheses.
COMPARISON OF THE DEVICE CHARACTERISTICS TO THE PREDICATE
Physical properties of the Carboflo vascular grafts were compared to the values for Standard IMPRA ePTFE vascular grafts, using methods recommended by the AAMI Vascular Graft Standard or the FDA Guidance Document on Vascular Prostheses. Testing of a variety of product types shows that the addition of carbon particles into the graft wall did not affect the physical properties of the Carboflo grafts. Both the new device and predicate device undergo the same testing and evaluation procedures. The acceptance criteria for both the new device and predicate devices are the same.
NON-CLINICAL TESTING
Carbon containing surfaces in medical devices, e.g. Heart valves, have been shown to impart anti-thrombogenic properties'. Short-term pre-clinical studies have been conducted with IMPRA Carboflo™ ePTFE Vascular Grafts to determine the performance of carbon containing blood contact surface. Animal studies comparing the Carboflo grafts with Standard IMPRA ePTFE grafts have shown that the inside surfaces of the Carboflo grafts have a significantly higher Thrombus Free Surface Area after 3 months2. Patencies of both Carboflo and Standard grafts were similar. Short-term animal studies in dogs and rabbits have shown that the Carboflo inside surfaces have reduced platelet accumulation when compared to Standard ePTFE vascular grafts, suggesting that the addition of carbon particles reduces the thrombogenicity of the surface3.
Additional bench testing performed to determine the response of the Carboflo ePTFE graft compared to the Standard ePTFE in repeated puncture test and the
2 Data on file
3 References on file ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
l References on file
2
particulate flow test showed them to be equivalent.
CLINICAL INFORMATION
A multi-center, prospective, randomized clinical trial comparing IMPRA Carboflo™ ePTFE Vascular Grafts to commercially available ePTFE Vascular Grafts, was performed in France between 1990-1994. The purpose of the investigation was to compare the patencies of both IMPRA Carboflo ePTFE Vascular Grafts and Standard ePTFE Vascular Grafts. A total of 81 patients received Carboflo grafts and 79 received Standard ePTFE grafts. All grafts were implanted to treat lower extremity vascular disease. Of the 160 grafts, only 5 grafts (3 Carboflo, 2 Standard) were considered to be Above-Knee, and the remaining grafts were all Below-Knee.
73% of the distal anastomoses were direct graft to vessel, with the following types comprising the other anastomoses: venous patch (16%), distal arterio-venous fistula (5.8%), or interpositional vein cuff graft (5.2%). All implanted grafts were followed for at least 24 months, or until failure, lost to follow-up, or death of patient. Adverse events were recorded and documented on Case Report Forms (CRF).
Analysis
...
PRIMARY PATENCY was defined as the time between implant date and date of follow-up when the graft was patent, prior to the first intervention to correct complications. Interventions included immediate re-operations to correct any complication post implantation. SECONDARY PATENCY was defined as the time between implant date and date on which the graft is no longer patent or useful, after a series of interventions. Conventional life-tables were then constructed to determine the Cumulative Primary and Secondary Patencies. At the end of the 2 yr follow-up, patencies were as follows:
Cumulative Primary Patency for Carboflo grafts was 36.8 % compared to 27.7% for Standard grafts at the end of 24 months.
Cumulative Secondary Patency for Carboflo grafts was 42.7% compared to 32.3% for Standard grafts.
These results are not statistically significantly different at p=0.05.
3
DEVICE SAFETY was demonstrated by determining adverse events for both Carboflo and Standard grafts. Complications were counted as they were encountered and added up at the end of the study period for each patient. The results are tabulated below:
| Adverse event | Device Type | |
|---|---|---|
| Standard | Carboflo | |
| No. At Start | 79 | 81 |
| No. LFU @2yrs * | 7 | 17 |
| No. Patent @2yrs | 17 | 16 |
| No. Immed. Redos | 6 | 12 |
| No. Failed @2yrs | 52 | 43 |
| Thrombosis | 34 | 26 |
| False aneurysm | 1 | 1 |
| Infection | 5 | 4 |
| Other adverse events | 2 | 3 |
| Amputation | 26 | 28 |
| Deaths | 16 | 13 |
COMPLICATIONS: CARBOFLO VS. STANDARD
- LFU = Lost to follow-up
It is important to note that no new type of complications were identified with Carboflo grafts.
RISK FACTORS in patients with Carboflo and Standard ePTFE Vascular Grafts were similar (p > 0.05), except for Smoking. There were a higher number of patients who were smokers, in the Carboflo group (p0.05), except for Smoking. There were a higher number of patients who were smokers, in the US (p