FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

K021547 · Jotec GmbH · DSY · Jan 24, 2003 · Cardiovascular

Device Facts

• Record ID: K021547
• Device Name: FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
• Applicant: Jotec GmbH
• Product Code: DSY · Cardiovascular
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstruction - femorofemoral and axillofemoral. Standard wall FlowLine BiporeePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

Device Story

Jotec FlowLine Bipore ePTFE Vascular Graft is a tubular prosthesis composed of expanded polytetrafluoroethylene (ePTFE). Device may include external orientation marks and an optional external FEP double helix support. Used by surgeons for arterial vasoreconstruction in peripheral vascular regions, extraanatomical bypasses (femorofemoral, axillofemoral), and as arteriovenous shunts for hemodialysis. Device serves as a permanent implant to replace or bypass diseased vessels, facilitating blood flow and vascular access. Substantial equivalence established via mechanical and material testing against predicate ePTFE grafts.

Clinical Evidence

Bench testing only. Mechanical testing and material analysis performed per FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions to demonstrate material strength and chemical identity equivalence to predicate devices.

Technological Characteristics

Material: pure expanded polytetrafluoroethylene (ePTFE). Optional external FEP (fluorinated ethylene propylene) double helix support. Form factor: tubular graft. Sterilization: not specified. Connectivity: N/A (implantable device).

Indications for Use

Indicated for patients requiring arterial vasoreconstruction in the peripheral vascular region, extraanatomical reconstruction (femorofemoral and axillofemoral), or arteriovenous shunt prostheses for hemodialysis.

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 grafts
• Gore-Tex ePTFE vascular grafts

Submission Summary (Full Text)

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K621547

JAN 2 4 2003

### 510 (k) Summary

| Submitter: | Jotec GmbH<br>Lotzenacker 23 Hechingen, Germany 72379<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Ralf Kaufmann |
| Date Summary Prepared: | May 9th, 2002 |
| Trade or Proprietary Name: | Jotec® FlowLine™ Bipore ePTFE Vascular Graft |
| Common or Usual Name: | ePTFE Vascular Graft |
| Classification Name: | Prosthesis, vascular graft of 6 millimeters or greater<br>diameter |
| Predicates: | Impra and Gore-Tex® and ePTFE vascular grafts. |

### Device Description:

The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.

The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.

Non-clinical bench testing, as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions demonstrated through mechanical testing and material analysis that the Jotec FlowLine Bipore ePTFE Vascular Graft is substantially equivalent to the predicate devices.

#### Statement of Intended Use:

The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstruction - femorofemoral and axillofemoral. Standard wall FlowLine BiporeePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

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## Substantial Equivalence Conclusion:

Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FlowLine Bipore ePTFE Vascular Graft and predicate Gore-Tex® and Impra, Inc, ePTFE vascular grafts are substantially equivalent.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jotec GmbH c/o Mr. Bruce Ruefer Bridger Biomed 2430 N. 7th Avenue, Suite 4 Bozeman, MT 59715

Re: K021547

Jotec GmbH Flowline™ Bipore ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: November 5, 2002 Received: November 6, 2002

Dear Mr. Ruefer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bruce Ruefer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 10 Statement of Indication for Use

#### Indication for Use:

The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral.

Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

ason Devices

**510(k) Number:** K021547

Prescription Use_X (Per 21 CFR 801.109)