PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452

K984182 · Possis Medical, Inc. · DSY · Feb 1, 1999 · Cardiovascular

Device Facts

• Record ID: K984182
• Device Name: PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
• Applicant: Possis Medical, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only. - Thinwall Perma-Pass Grafts are not indicated for blood access. - Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; - ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava

Device Story

Perma-Pass Vascular Graft is a straight, isodiametric PTFE vascular prosthesis; used for arterial bypass, reconstruction, or arteriovenous conduits for blood access. Manufactured via paste extrusion, expansion, and sintering of PTFE resin; includes black pigment orientation line. Implanted by surgeons in clinical settings. Device serves as a permanent vascular conduit; provides structural support for blood flow. Benefits include restoration of vascular patency or establishment of hemodialysis access. Performance verified through in vitro, functional, physical, and biocompatibility testing; results exceed physiological requirements.

Clinical Evidence

Bench testing only. No clinical data presented. In vitro, functional, physical, and biocompatibility testing performed per USP/AAMI guidelines. Results demonstrate performance comparable to predicate device and exceeding physiological requirements.

Technological Characteristics

Materials: PTFE resin, lubricant, black pigment. Fabrication: Paste extrusion, expansion, sintering. Configuration: Straight, isodiametric. Dimensions: 6mm internal diameter, thin and standard wall variants. Sterilization: Same as Perma-Flow Graft. No software or electronic components.

Indications for Use

Indicated for bypass or reconstruction of occluded or diseased arterial blood vessels or creation of subcutaneous arteriovenous conduits for blood access. Contraindicated for thinwall grafts in blood access applications and for use in pulmonary arteries, ascending aorta, coronary arteries, carotid arteries, cerebral arteries, brachiocephalic trunk, cardiac/pulmonary veins, or vena cava.

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 Straight (K791810)

Reference Devices

• Perma-Flow® Coronary Bypass Graft (H970005)

Submission Summary (Full Text)

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

KG84182

Image /page/0/Picture/1 description: The image is a logo for Possis Medical Inc. The logo features a stylized "M" inside a square on the left, followed by the word "Possis" in bold, sans-serif font. Below "Possis" is the text "MEDICAL INC" in a smaller, sans-serif font. The logo is black and white.

9055 Evergreen Blvd. N.W. Minneapolis, Minnesota 55433-8003 USA

[phone] Fax [phone]

4

FEB 1 1999

# PERMA-PASS™ VASCULAR GRAFT 510(K) SUMMARY

## NOVEMBER 1998

### SUBMITTER'S INFORMATION

CONTACT

Possis Medical, Inc. 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433

Tel: [phone] Fax: [phone]

Primary

Timothy J. Kappers Sr. Regulatory Affairs Associate

Alternate

James D. Gustafson Vice President of Quality Systems and Regulatory/Clinical Affairs

November 18, 1998

Perma-Pass™ Vascular Graft

Vascular Graft

Vascular Graft prosthesis of 6 mm and greater diameter (74DSY, 21 CFR 870.3460)

IMPRA ePTFE Vascular Graft Straight; 6 mm x 50 cm K791810 IMPRA, Inc. 1625 West Third Street Tempe, Arizona 85281

SUMMARY DATE

DEVICE TRADE NAME

COMMON NAME

DEVICE CLASS

LEGALLY MARKETED PREDICATE DEVICE

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

#### DEVICE DESCRIPTION

The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manıfacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 6mm, thin and standard wall, and lengths sufficient to satisfy most vascular graft applications.

The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.

#### INTENDED USE

The Perma-Pass Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

- . Thinwall Perma-Pass Grafts are not indicated for blood access.
- Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava

#### COMPARISON TO PREDICATE DEVICE:

Table 1 summarizes key technical characteristics and physical properties of the Perma-Pass Graft and the predicate device. This information is provided for two graft sizes denoted as follows: thin wall 6mm internal diameter (6T), and standard wall 6mm internal diameter (6S).

| | IMPRA Graft | Perma-Pass Graft |
|--------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|
| Materials | PTFE: No additives | PTFE: No additives |
| Markings | Longitudinal orientation | Longitudinal orientation |
| Clinical application | Vascular access and others | Vascular access and others |
| Fabrication | Paste extrusion, expansion,<br>sintering | Paste extrusion, expansion,<br>sintering |
| Structure | | |
| Configuration | Straight, isodiametric | Straight, isodiametric |
| Dimensions | | |
| | IMPRA Graft | Perma-Pass Graft |
| Length (all sizes) | 50cm | 70cm |
| Internal diameter | 6T: 5.89mm | 6T: 6.06mm |
| | 6S: 5.93mm | 6S: 6.08mm |
| Wall Thickness | 6T: 0.431mm | 6T: 0.422mm |
| | 6S: 0.665mm | 6S: 0.643mm |
| Physical properties | | |
| Pore volume | 6T: 71% | 6T: 68% |
| | 6S: 72% | 6S: 72% |
| Internodal distance | 6T<br>Inner: 17µm<br>Outer: 20µm | 6T<br>Inner: 18µm<br>Outer: 20µm |
| | 6S<br>Inner: 25µm<br>Outer: 22µm | 6S<br>Inner: 25µm<br>Outer: 26µm |
| Kink diameter | 6T: 18mm | 6T: 16mm |
| | 6S: 16mm | 6S: 13mm |
| Water entry pressure | 6T: 321mmHg | 6T: 326mmHg |
| | 6S: 274mmHg | 6S: 228mmHg |
| Pressurized burst strength | 6T: 303kPa | 6T: 394kPa |
| | 6S: 405kPa | 6S: 486kPa |
| Pressurized burst after<br>repeated puncture (after 18<br>months simulated puncture) | | 6S: 324kPa |
| | 6S: 237kPa | |
| Tensile Strength | | |
| Longitudinal | 6T: 119N | 6T: 135N |
| | 6S: 120N | 6S: 207N |
| Circumferential | 6T: 3.03N/mm | 6T: 4.47N/mm |
| | 6S: 3.73N/mm | 6S: 4.42N/mm |
| Suture retention strength | | |
| Longitudinal | 6T: 282g | 6T: 447g |
| | 6S: 451g | 6S: 734g |
| Oblique | 6T: 260g | 6T: 496g |
| | 6S: 434g | 6S: 498g |

#### TABLE 1 Comparison of Technical Characteristics

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

#### NON-CLINICAL TESTS

Extensive testing of in vitro, functional, physical, and biocompatibility tests have been performed on the Perma-Pass Graft. These tests have shown that the Graft performs comparably to the predicate device. All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases.

CONCLUSION

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

The Perma-Pass Vascular Graft is a 6mm straight vascular prosthesis, intended as a permanent implant for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The present 510(k) compares the Perma-Pass Graft to a legally marketed predicate device. The intended use, graft configuration, material, labeling, method of use, intended anatomical sites, and the target population of the Perma-Pass Graft are the same as those of the predicate device.

The Perma-Pass Graft is manufactured from PTFE, well known to the market with a long history of successful implantation in the human body. There are no known technological differences between the subject device and the predicate device. Extensive testing has shown the subject device is equivalent to the predicate device.

As summarized above, this 510(k) notification provides adequate information to support a determination of substantial equivalence between the Perma-Pass Graft and its predicate device.

7

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Mr. Timothy J. Kappers Sr. Requlatory Affairs Associate Possis Medical, Inc. 9055 Evergreen Boulevard, N.W. Minneapolis, MN 55433-8003

Re : K984182 Perma-Pass™ Vascular Graft, 6S Graft, Model 31453 and 6T Graft, Model 31452 Requlatory Class: II (Two) Product Code: 74 DSY November 20, 1998 Dated: Received: November 23, 1998

Dear Mr. Kappers:

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 legally marketed predicate 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 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.

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

### Page 2 - Mr. Timothy J. Kappers

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 `Misbranding by reference to premarket notification' (21 entitled, 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/dsma/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

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

{6}------------------------------------------------

K984182

Possis Medical Inc

# PERMA-PASS™ VASCULAR GRAFT INDICATION FOR USE STATEMENT

## NOVEMBER 1998

The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

- Thinwall Perma-Pass Grafts are not indicated for blood access. .
- Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava

Bert L. Campbell

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

510(k) Number K984182

prescription use