IMPRA HIGH POROSITY GRAFT

K983064 · Impra, Inc. · DSY · Nov 19, 1998 · Cardiovascular

Device Facts

• Record ID: K983064
• Device Name: IMPRA HIGH POROSITY GRAFT
• Applicant: Impra, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IMPRA High Porosity Graft in Straight and IMPRA Flex configurations is indicated for use as a vascular prosthesis for bypass or reconstruction of arterial blood vessels. IMPRA Flex configurations have an external spiral bead support on the graft and can be used where resistance to compression or kinking is desired.

Device Story

IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular prosthesis. Available in straight and 'IMPRA Flex' configurations; the latter includes an external spiral bead support to provide resistance to compression and kinking. Used by surgeons for bypass or reconstruction of arterial blood vessels. Device functions as a permanent implant to restore or redirect blood flow. Benefits include structural support for arterial repair and mechanical stability in peripheral applications.

Clinical Evidence

Bench testing only. Testing performed per ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance for Vascular Graft Prostheses. Results confirmed the device is suitable for intended use and performs equivalently to predicate devices.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Construction: high porosity. Configurations: straight and flex (with external spiral bead support). Standards: ANSI/AAMI VP20-1994. Sterilization: not specified.

Indications for Use

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

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 ePTFE Vascular Graft
• Atrium Hybrid PTFE Vascular Graft

Submission Summary (Full Text)

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

K983064

NOV 1 9 1998

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

Image /page/0/Picture/3 description: The image shows the word "IMPRA" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. The word is presented in a slightly slanted or italicized style, adding a sense of dynamism to the design. The background is plain white, which makes the black letters stand out prominently.

CONFIDENTIAL

## 510(k) Premarket Notification IMPRA High Porosity Grafts

# 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: | August 27, 1998 |

#### Device Name B.

| Trade Name: | IMPRA High Porosity Grafts |
|-----------------------|------------------------------------------------------------------------|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of greater than or equal to 6 mm<br>diameter |

IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\HP510K6.kmk.WPD**21**

000027

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

#### C. Predicate Device Name

Trade Name(s):

IMPRA ePTFE Vascular Graft Atrium Hybrid PTFE Vascular Graft

#### D. Device Description

The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.

#### E. Intended Use

The IMPRA High Porosity Graft in Straight and IMPRA Flex configurations is indicated for use as a vascular prosthesis for bypass or reconstruction of arterial blood vessels. IMPRA Flex configurations have an external spiral bead support on the graft and can be used where resistance to compression or kinking is desired.

#### F. Technological Characteristics Summary

The IMPRA High Porosity Graft is an IMPRA ePTFE Vascular Graft with a high porosity construction.

#### G. Performance Data

Device testing was performed on the IMPRA High Porosity Graft and compared to the results of testing performed on the IMPRA ePTFE Vascular Graft. The testing was conducted using methods recommended in ANSI/AAMI 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 IMPRA High Porosity Graft is suitable for use as vascular prostheses for bypass or reconstruction of arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the IMPRA High Porosity Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.

IMPRA High Porosity Grafts are substantially equivalent to the currently marketed IMPRA ePTFE Vascular Graft and the Atrium Hybrid PTFE Vascular Graft.

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

Image /page/2/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 an eagle with its wings spread.

NOV 1 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street Tempe, AZ 85281

Re : K983064 IMPRA High Porosity Graft Regulatory Class: II (Two) Product Code: 74 DSY Dated: August 27, 1998 September 2, 1998 Received:

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 registration, 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 regulations 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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.

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

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

NOV 1 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street Tempe, AZ 85281

Re: K983064 IMPRA High Porosity Graft Requlatory Class: II (Two) Product Code: 74 DSY Dated: August 27, 1998 Received: September 2, 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 registration, 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 regulations 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 regulation (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 regulation 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 regulation (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 general 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): K983064

Device Name:_IMPRA High Porosity Grafts

Indications For Use: IMPRA High Porosity Grafts are indicated for use as vascular prosthesis 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)

Rette & Reumerele

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)