DISTAFLO BYPASS GRAFT

K983769 · Impra, Inc. · DYF · Dec 15, 1998 · Cardiovascular

Device Facts

• Record ID: K983769
• Device Name: DISTAFLO BYPASS GRAFT
• Applicant: Impra, Inc.
• Product Code: DYF · Cardiovascular
• Decision Date: Dec 15, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

Device Story

Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft featuring a cuffed distal end. Device is manufactured with or without Flex beading and with or without a carbon lining. Distal cuff geometry is modeled after Miller Vein Cuff. Device is intended for surgical bypass or reconstruction of peripheral arterial blood vessels. It is a permanent implant used by vascular surgeons in clinical settings.

Clinical Evidence

Bench testing only. Testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon. Testing followed ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance for Vascular Graft Prostheses. Results demonstrated the device is suitable for its intended use and performs substantially equivalent to predicate devices.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) vascular graft. Features cuffed distal end modeled after Miller Vein Cuff. Options include Flex beading and carbon lining. Testing conducted per ANSI/AAMI VP20-1994.

Indications for Use

Indicated for patients requiring bypass or reconstruction of peripheral arterial blood vessels.

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

• IMPRA Carboflo® Vascular Graft
• Venaflo® Vascular Graft (Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date December 16, 1998. The month is represented by the abbreviation DEC. The day is the 16th, and the year is 1998. The text is in a bold, sans-serif font.

### IMPRA

A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: [phone] FAX: [phone]

1. 1. 5.

K983769

Image /page/0/Picture/4 description: The image shows the word "IMPRA" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. The image is in black and white, and the letters are solid black. The font is thick and blocky, giving the word a strong and impactful appearance.

CONFIDENTIAL

## 510(k) Premarket Notification DISTAFLOTM Bypass Graft

### 510(k) SUMMARY

#### Submitter Information A.

| Submitter's Name: | IMPRA, Inc.<br>A Subsidiary of C. R. Bard, Inc. |
|----------------------|--------------------------------------------------|
| Address: | 1625 West Third Street<br>Tempe, Arizona 85281 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Kristi M. Kistner<br>Manager, Regulatory Affairs |
| Date of Preparation: | October 22, 1998 |

#### B. Device Name

| Trade Name: | Dista <i>flo</i> ™ Bypass Graft |
|-----------------------|------------------------------------------------------|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of less than 6 mm diameter |

IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\DistafloLT6.wpd**25**

Image /page/0/Picture/12 description: The image shows the word "BRAND" in a stylized font. The letters are outlined and appear to be slightly faded or distressed. The word is centered and takes up most of the frame.

000000

{1}------------------------------------------------

### C. Predicate Device Name

Trade Name(s):

IMPRA Carboflo® Vascular Graft Venaflo® Vascular Graft (Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon)

#### D. Device Description

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

#### E. Intended Use

The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.

### ﺘﺸ Technological Characteristics Summary

The Distaflo Bypass Graft is manufactured using the same materials and processes as the predicate devices. The shape of the distal cuff is modeled after the Miller Vein Cuff.

#### (;. Performance Data

Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon. The testing was conducted using methods recommended in ANSVAAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. The results of all testing indicated that the Distaflo Bypass Graft is suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the Distaflo Bypass Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.

{2}------------------------------------------------

Distaflo Bypass Grafts are substantially equivalent to the currently marketed IMPRA Carboflo Vascular Graft and the Venaflo Vascular Graft.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is depicted as a staff with two snakes coiled around it, and a pair of wings at the top.

# DEC 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristi M. Kistner Manager, Requlatory Affairs IMPRA, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85281-1740

Re : K983769 IMPRA Distaflo™ Bypass Graft Regulatory Class: III (Three) Product Code: 74 DYF Dated: October 22, 1998 Received: October 26, 1998

Dear Ms. Kistner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Ms. Kristi M. Kistner

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K983769 and K983861

Device Name:_Impra Distaflo™ Bypass Graft

Indications For Use: Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983769/K983861

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use*_*_

(Optional Format 1-2-96)