BARD GRAFT SIZER

K961134 · C.R. Bard, Inc. · DSY · Jun 19, 1996 · Cardiovascular

Device Facts

• Record ID: K961134
• Device Name: BARD GRAFT SIZER
• Applicant: C.R. Bard, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Jun 19, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2

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.

Device Story

Caliper-type manual measurement tool; used by physicians during vascular procedures. Device consists of rotating pointer and scale joined by eyelet; includes integrated 9cm ruler. Measures blood vessel inner diameter (6-38mm) and outer diameter (2-38mm). Physician aligns device edges with vessel boundaries to determine graft sizing. Facilitates accurate graft selection; aids in determining vessel/graft lengths.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with FDA General Program memorandum #G95-1 Attachment A; all testing successfully completed.

Technological Characteristics

Manual caliper-type design. Materials: Polyester pointer, Polystyrene scale, brass eyelet, medical-grade PVC ink for silkscreen. Measurement range: 6-38mm ID, 2-38mm OD. Integrated 9cm ruler (1mm scale). Sterilization: Gamma radiation.

Indications for Use

Indicated for use by physicians to measure patient blood vessel inner and outer diameters to assist in selecting appropriate vascular graft sizes and lengths. No specific patient population or contraindications identified.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Meadox Graft Sizer

Submission Summary (Full Text)

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JUN 19 1996
K961134

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

**BARD**

# 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 #: [phone]
Fax #: [phone]
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

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.

## 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.

Bard® Graft Sizer 510(k) Submission
26

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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's IFU) | | 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. | The MEADOX Graft sizer is designed to aid the physician in determining the relationship between the size of the patient's blood vessel and the appropriate graft diameter. |
| Contraindications | | None | None |
| Packaging | | Peel Pull style pouch. Each unit is placed in it's own unit box. | Peel Pull style pouch. Each unit is boxed with a vascular graft. |
| Sterilization | | Gamma Radiation | Gamma Radiation |
| Method of Operation | | Manual | Manual |
| Range of Measure | | From 6mm-38mm ID
From 2mm-38mm OD | Obturators available in sizes 5,6,7,8,9,10,11,12,14,16,18 20,22,and 24 mm. |
| Component Materials | Pointer | Polyester | N/A |
| | Scale | Polystyrene | N/A |
| | Eyelet | brass | N/A |
| | Pointer silkscreen | Medical Grade PVC ink | N/A |
| | Scale Silkscreen | Medical Grade PVC ink | N/A |
| | Meadox obturators | N/A | polystyrene |

Bard® Graft Sizer 510(k) Submission

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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.

Bard® Graft Sizer 510(k) Submission