(90 days)
The Bard Vascular Graft Sizer is designed to assist the physician in determining the relationship between the inner and outer diameter of the patient's blood vessel and the appropriate vascular graft diameter. The ruler may also aid in determining vessel/graft lengths.
This vascular graft sizer is a caliper-type design consisting of two parts: a graft sizer scale and a graft sizer pointer. These are joined together with an eyelet to allow the pointer to rotate. This device may measure inner diameter (I.D.) Of a blood vessel from 6mm to 38mm and the outer diameter (O.D.) From 2mm to 38mm. In addition, on the opposite side, there is a 9cm ruler, graded to a 1mm scale.
The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria, as it focuses on the 510(k) summary for the Bard® Graft Sizer. The document details the device's description, intended use, technological characteristics, and a comparison to a predicate device. It briefly mentions "biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A. All testing was successfully completed," but it does not elaborate on the specific acceptance criteria for this testing, the study design, or the results that would meet the requirements of your request.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input.
§ 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.”