(77 days)
The Standard Wall Exxcel™ and Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal) and to provide vascular access. Thin Wall Exxcel™ soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal). The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).
EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts: EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vascular grafts constructed of extruded, expanded polytetrafluoroethylene (ePTFE). They are available in various configurations, with the following features: EXXCEL™ grafts have a unique cross-helical PTFE yarn wrap to enhance mechanical strength, minimize kinking and increase suture retention strength. EXXCEL™ Soft grafts are ePTFE grafts without a yarn wrap, that possess enhanced handling characteristics. Straight grafts (available in EXXCEL™ & EXXCEL™ Soft) have a uniform diameter throughout their length. Short Taper and Step grafts (available in EXXCEL™ & EXXCEL™ Soft) are designed to have the arterial anastomosis of vascular access procedures created with the smaller diameter end to reduce the risk of steal syndrome. Externally Supported grafts (available only in . EXXCEL™ Soft) have a removable, continuous spiral support coil to increase compression resistance and to minimize kinking. Centrally Supported grafts (available in EXXCEL™ & . EXXCEL™ Soft) have a non-removable, continuous spiral support coil located in the center of the graft's length, to provide additional kink and compression resistance for grafts implanted in a looped configuration for vascular access. All EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts feature a GUIDELINE™ Stripe to facilitate proper graft alignment.
MICROVEL™ KNITTED DOUBLE VELOUR: This seamless knitted double velour polyester graft incorporates a lower inner pile for minimal luminal compromise and a higher outer pile to promote perigraft tissue adherence. This graft is soft, pliable, and complies with ease to the host vessel. This graft features CONCENTRICRIMP™ Pleats, which assist in proper length adjustment of the prosthesis and maintenance of an open lumen at the anastomosis, and throughout the entire graft. There is a GUIDELINE™ Stripe to facilitate proper graft alignment. The knitted velour construction of this graft is preferred by surgeons in abdominal and peripheral procedures. Not recommended for thoracic procedures.
WOVEN DOUBLE VELOUR : This seamless woven polyester graft incorporates a velour inner pile to promote attachment of the pseudointima and a velour outer pile to promote perigraft tissue adherence. The unique woven double velour construction provides soft and supple handling characteristics, while maintaining a low porosity. CONCENTRICRIMP™ Pleats help in proper length adjustment of the prosthesis and maintenance of an open lumen at the anastomosis, and throughout the entire graft, while the two GUIDELINE™ Stripes help provide greater assurance of proper graft alignment. The Woven Double Velour graft is suitable for use in thoracic, abdominal and peripheral procedures.
COOLEY™ VERI-SOFT™: The COOLEY™ VERI-SOFT™ graft is tightly woven polyester to maintain a low, controlled porosity level for minimal blood loss and high burst strength. This unique design offers significant advantages to heparinized patients or to those with rare blood types or coagulopathies. The soft texture provides a supple graft with enhanced healing characteristics. CONCENTRICRIMP™ Pleats resist kinking, reduce stress on the suture line and assist in proper length adjustment. The intrawoven GUIDELINE™ Stripe aids in graft alignment. The COOLEY™ VERI-SOFT™ woven graft is suitable for use in thoracic and abdominal procedures.
The provided text is a 510(k) summary for vascular grafts. It does not contain any information about acceptance criteria or a study proving device performance using AI or human readers.
This document describes a submission for device clearance. The key points are:
- No new studies were conducted to establish acceptance criteria or device performance in the context of AI or human reader evaluation.
- The 510(k) submission clarifies the indications for use statement for existing, already cleared vascular grafts by listing specific arteries for which the devices have a safe history of use.
- The conclusion states that the devices are safe and effective because "the only change made to these already cleared devices is the addition of a listing of arteries in which the devices have a safe history of use."
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on clarifying existing indications for use for already-marketed devices, rather than on new performance studies with specific acceptance criteria or AI/human reader evaluations.
§ 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.”