(150 days)
No
The summary describes a physical vascular graft and its performance in clinical trials. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is designed to repair or replace peripheral arteries, directly acting on the body to restore physiological function.
No
The device is a vascular graft designed to repair or replace peripheral arteries, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a synthetic vascular graft constructed of physical materials (ePTFE and knitted polyester textile), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair or replace peripheral arteries." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "synthetic vascular graft," which is an implantable medical device used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Focus of Studies: The performance studies focus on the physical properties of the graft, its biocompatibility, and its clinical performance in terms of patency and adverse events after implantation. These are typical evaluations for implantable surgical devices, not IVDs.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a replacement for damaged arteries.
N/A
Intended Use / Indications for Use
FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
FUSION™ Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knitted polyester textile. These two layers are bonded together. The FUSION™ Bioline Vascular Grafts have a heparin/albumin coating on the interior surface of the graft.
Mentions image processing
Vascular imaging
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, biocompatibility, animal and clinical testing were performed to support a determination of substantial equivalence.
Bench testing performed: Longitudinal Tensile Strength, Wall Thickness, Oblique Suture Retention Strength, Longitudinal Suture Retention Strength, Kink Diameter, Relaxed Internal Diameter, Longitudinal Axial Stretch, Water Entry Pressure (WEP), Radial Burst Strength (Burst Pressure), Usable Length, Shear Bond Strength. Also for products with external support (supported): Bead Peel Strength, Bead Wrap Density, Crush Resistance. For FUSION Bioline, grafts were additionally tested for: Heparin concentration.
Animal studies:
The FUSION/FUSION Bioline Vascular Grafts were tested in two animal models.
In vivo canine and porcine implant studies were performed to assess device safety by evaluating vascular compatibility.
The canine study was designed to address tissue response and patency. The model used for the canine study was a femoral arteriovenous shunt; the study compared the FUSION Vascular Graft with Exxcel Soft Vascular Graft.
Key Results: Patency was comparable for the FUSION Vascular Graft and Exxcel Soft Grafts. The healing process of the FUSION Vascular Graft was comparable with the Exxcel Soft Graft. Both Grafts demonstrated a benign healing response with no evidence of safety concerns.
The porcine study compared FUSION to FUSION Bioline and FUSION Bioline to GORE PROPATEN in a porcine carotid model. FUSION to FUSION Bioline were compared for comparable surfaces and expected clinical hemocompatibility. The surfaces were found to be comparable as well as comparable to Exxcel. FUSION Bioline was compared to GORE PROPATEN for patency and tissue response. The grafts remained widely patent in both groups and tissue response was similar.
Clinical Studies:
Randomized Multicenter Trial of FUSION Bioline Graft for Femoropopliteal Bypass
Study Type: Prospective, randomized, multicenter trial.
Sample Size: 207 subjects.
Data Source: Eighteen US and 7 European centers enrolled 207 subjects with Rutherford 1-5 chronic limb ischemia and planned prosthetic femoropopliteal (above- and below-knee) bypass. Subjects were randomized 1:1 to either FUSION-Bioline or EXXCEL Soft ePTFE. Patency was assessed by vascular imaging and ABI.
Key Results: Primary patency at 6 months was 86.4% for FUSION Bioline compared to 70.0% for the EXXCEL group. The difference was 16.4% with a non-inferiority p-value of
§ 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
·
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| 510(k) Number: | K131778 |
|---|---|
| Date Prepared: | September 12, 2013 |
| Device Owner: | MAQUET Cardiovascular LLC |
| 45 Barbour Pond Drive | |
| Wayne, New Jersey 07470 | |
| Contact Personnel: | |
| Title: | |
| Email: | |
| Phone: | Marylou Insinga |
| Regulatory Affairs Specialist II | |
| marylou.insinga@maquet.com | |
| 973-709-7442 | |
| Fax: 973-807-1658 | |
| Trade Name: | FUSION™ and FUSION™ Bioline Vascular Grafts |
| Common Name: | Vascular Graft |
| Classification Name: | Vascular Graft Prosthesis |
| Predicate Device: | EXXCEL™ Soft ePTFE Vascular Grafts (K962433, K052964 and |
| K113101) | |
| Device Description: | FUSION™ Vascular Grafts are synthetic vascular grafts |
| constructed of two layers. The inner layer is comprised of | |
| expanded polytetrafluoroethylene (ePTFE). The outer layer is | |
| comprised of knitted polyester textile. These two layers are | |
| bonded together. The FUSION™ Bioline Vascular Grafts have a | |
| heparin/albumin coating on the interior surface of the graft. | |
| Indications for Use: | FUSION™ and FUSION™ Bioline Vascular Grafts are designed to |
| repair or replace peripheral arteries. | |
| Technological | |
| Characteristics | |
| Safety and Performance: | Bench testing, biocompatibility, animal and clinical testing were |
| performed to support a determination of substantial | |
| equivalence. | |
| Bench testing performed: | |
| Longitudinal Tensile StrengthWall ThicknessOblique Suture Retention StrengthLongitudinal Suture Retention StrengthKink DiameterRelaxed Internal DiameterLongitudinal Axial StretchWater Entry Pressure (WEP)Radial Burst Strength (Burst Pressure)Usable LengthShear Bond Strength |
NOV 1 4 2013
1
Also for products with external support (supported):
- o Bead Peel Strength
- o Bead Wrap Density
- Crush Resistance o
For FUSION Bioline, grafts were additionally tested for: Heparin concentration.
Animal studies:
The FUSION/FUSION Bioline Vascular Grafts were tested in two animal models.
In vivo canine and porcine implant studies were performed to assess device safety by evaluating vascular compatibility. The canine study was designed to address tissue response and patency. The model used for the canine study was a femoral arteriovenous shunt; the study compared the FUSION Vascular Graft with Exxcel Soft Vascular Graft.
- · Patency was comparable for the FUSION Vascular Graft and Exxcel Soft Grafts.
- · The healing process of the FUSION Vascular Graft was comparable with the Exxcel Soft Graft. Both Grafts demonstrated a benign healing response with no evidence of safety concerns.
The porcine study compared FUSION to FUSION Bioline and FUSION Bioline to GORE PROPATEN in a porcine carotid model. FUSION to FUSION Bioline were compared for comparable surfaces and expected clinical hemocompatibility. The surfaces were found to be comparable as well as comparable to Exxcel. FUSION Bioline was compared to GORE PROPATEN for patency and tissue response. The grafts remained widely patent in both groups and tissue response was similar.
Clinical Studies:
Randomized Multicenter Trial of FUSION Bioline Graft for Femoropopliteal Bypass
Methods: Prospective, randomized, multicenter trial performed to evaluate the safety and efficacy of FUSION Bioline Vascular Graft to demonstrate substantial equivalence with EXXCEL Soft ePTFE. Eighteen US and 7 European centers enrolled 207 subjects with Rutherford 1-5 chronic limb ischemia and planned prosthetic femoropopliteal (above- and below-knee) bypass. Subjects were randomized 1:1 to either FUSION-Bioline or EXXCEL Soft ePTFE. Patency was assessed by vascular imaging and ABI. Early (6 month) results were analyzed for primary graft patency and major adverse limb events (MALE).
2
Efficacy Endpoints: Primary efficacy endpoint was primary patency of the graft at 6 months. Secondary endpoints were primary assisted patency, secondary patency, and time to hemostasis of suture hole bleeding.
Safety Endpoints: Composite MALE (major reintervention rates, major amputation rates) and periprocedural deaths at 6 months.
Results: Primary patency at 6 months was 86.4% for FUSION Bioline compared to 70.0% for the EXXCEL group. The difference was 16.4% with a non-inferiority p-value of