(35 days)
The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped and tapered grafts have a small diameter end and a large diameter end. All models of the graft have a printed black orientation line consisting of "LeMaitre LifeSpan" printed repeatedly along the length of the graft. This 510k is to add an alternative ink for the printing the orientation line.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the LifeSpan ePTFE Vascular Graft. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of an alternative ink for an orientation line.
The key information presented is:
- Device Description: LifeSpan ePTFE Vascular Graft with an alternative ink for the orientation line.
- Predicate Devices: Baxter reinforced expanded PTFE vascular grafts.
- Study Mentioned: "Biocompatibility test was performed for the alternative new ink. The biocompatibility of the device was tested per ISO10993-1."
- Conclusion: The manufacturer "has demonstrated that the LifeSpan ePTFE Vascular Graft printed with the new ink is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology."
- FDA Decision: FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details as this information is not present in the given text. The document does not describe a clinical study with acceptance criteria, human readers, or ground truth-setting for measuring device performance in the way a diagnostic AI or imaging device might. It's focused on materials biocompatibility and substantial equivalence for a vascular graft.
§ 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.”