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.

Device Description

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.

AI/ML Overview

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.

Summary

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KY61134

JUN 19 1996

Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000

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510(k) SUMMARY FOR THE BARD® GRAFT SIZER

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

A. Submitter Information

Submitter's Name: Bard Vascular Systems, C.R. Bard Inc. Address: 25 Computer Drive, Haverhill, MA 01832 Phone #: (508) 373-1000 Fax #: (508) 374-6200 Contact Person: Sandra L. Perreand Date of Preparation: March 20, 1996

B. Device Name

Trade Name: Bard Vascular Graft Sizer Common/Usual Name: graft sizer Classification Name: vascular graft prosthesis, 6mm greater accessory

C. Predicate Device

Trade Name: Meadox Graft Sizer

D. Device Description

E. Intended Use

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.

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F. Technological Characteristics Summary

Both the Bard graft sizer and the Meadox graft sizer are intended to be used in assisting the physician in measuring a patient's blood vessel(s) in order that he/she may select a vascular graft of appropriate size. Both devices are hand held, manually operated devices which obtain measurements by aligning the edges of the device to the inner or outer edge of the vessel, however, the Bard Graft Sizer is of a different design and is manufactured using slightly different materials than the Meadox Graft Sizer. For a comparison of the two device designs and material characteristics see Table VI-I below.

Table VI-I Comparison of General Characteristics
CHARACTERISTICS		BARD GRAFT SIZER	MEADOX GRAFT SIZER
Indications For Use(from the device'sIFU)		The Bard Vascular GraftSizer is designed to assistthe physician in determiningthe relationship between theinner and outer diameter ofthe patient's blood vesseland the appropriate vasculargraft diameter. The rulermay also aid in determiningvessel/graft lengths.	The MEADOX Graft sizeris designed to aid thephysician in determining therelationship between the sizeof the patient's blood vesseland the appropriate graftdiameter.
Contraindications		None	None
Packaging		Peel Pull style pouch. Eachunit is placed in it's ownunit box.	Peel Pull style pouch. Eachunit is boxed with a vasculargraft.
Sterilization		Gamma Radiation	Gamma Radiation
Method of Operation		Manual	Manual
Range of Measure		From 6mm-38mm IDFrom 2mm-38mm OD	Obturators available in sizes5,6,7,8,9,10,11,12,14,16,1820,22, and 24 mm.
Component Materials	Pointer	Polyester	N/A
	Scale	Polystyrene	N/A
	Eyelet	brass	N/A
	Pointersilkscreen	Medical Grade PVC ink	N/A
	ScaleSilkscreen	Medical Grade PVC ink	N/A
	Meadoxobturators	N/A	polystyrene

VI-I Comperison of General Characteristics

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G. Performance Data

The Bard Vascular Graft Sizer was subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A. All testing was successfully completed.

Regulation Number and Section

§ 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.”