EPTFE SLFTM SPIRAL VASCULAR GRAFT

K083169 · Tayside Flow Technologies Limited · DSY · Mar 30, 2009 · Cardiovascular

Device Facts

• Record ID: K083169
• Device Name: EPTFE SLFTM SPIRAL VASCULAR GRAFT
• Applicant: Tayside Flow Technologies Limited
• Product Code: DSY · Cardiovascular
• Decision Date: Mar 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ePTFE SLF™ Spiral Vascular Grafts are indicated for use as vascular prostheses. The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Device Story

Vascular graft prosthesis designed to induce spiral laminar flow; constructed from straight tubular expanded polytetrafluoroethylene (ePTFE) with helical PTFE beading injection-molded onto the external surface for reinforcement. Used by vascular surgeons in hospital operating theaters for peripheral arterial bypass or reconstruction. The spiral flow design aims to improve hemodynamic performance compared to standard grafts. Device is implanted surgically; provides a conduit for blood flow in diseased peripheral vessels.

Clinical Evidence

Bench testing and animal data provided. No human clinical trial data reported. Testing demonstrated safety and effectiveness equivalent to predicate devices.

Technological Characteristics

Vascular graft composed of expanded polytetrafluoroethylene (ePTFE) tube with external helical polytetrafluoroethylene (PTFE) beading. Beading is injection-molded to provide structural reinforcement. Designed to induce spiral laminar flow.

Indications for Use

Indicated for patients requiring bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. For use by trained physicians/surgeons in hospital operating environments.

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

• Veryan Medical Limited SwirlGraft Graft (K051312)
• Bard IMPRA DistaFlo® Bypass Graft (K983861)
• DynaFlo™ Bypass Graft (K050049)
• Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552)

Submission Summary (Full Text)

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K083169

MAR 3 0 2009

# Tayside Flow Technologies Ltd.

For the ePTFE SLF

™

Spiral Vascular Graft

# 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

#### Submitter's Name:

Tayside Flow Technologies Limited

#### Submitter's Address:

Tayside Flow Technologies Ltd: Unit 22, Prospect Business Centre Technology Park, Dundee Scotland, DD2 1TY

[phone] Telephone [phone] Fax

#### Establishment Registration Number:

Still to be obtained

#### Contact Person:

Edwin Lindsay

[phone] Telephone

#### Date Prepared:

20th October 2008

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# Tayside Flow Technologies Ltd. Traditional 510(k)

For the ePTFE SLF™ Spiral Vascular Graft

### 510(k) Summary

### Device Classification Information:

| Regulation<br>Number | Device Name | Device<br>Class | Product<br>Code | Classification<br>Panel |
|----------------------|---------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 870.3450 | Prosthesis, Vascular Graft,<br>Of 6mm And Greater<br>Diameter | Class 2 | DSY | Cardiovascular |
| 870.3450 | Prosthesis, Vascular Graft,<br>Of Less Then 6mm<br>Diameter | Class 2 | DYF | Cardiovascular |

#### Device Trade Name:

ePTFE SLF™ Spiral Vascular Graft

#### Device Common Name:

Vascular Graft with SLF™

#### Intended Use:

The ePTFE SLF™ Spiral Vascular Grafts are indicated for use as vascular prostheses.

The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.

ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

#### Summary of Substantial Equivalence:

The ePTFE SLF™ Spiral Vascular Grafts are substantially equivalent to Veryan Medical Limited SwirlGraft Graft (K051312), Bard IMPRA DistaFlo® Bypass Graft (K983861), DynaFlo™ Bypass Graft (K050049) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552)

#### Device Description:

The device is a vascular graft which has a specially designed section intended to induce spiral laminar flow. The grafts are manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft, supplied by Vascutek Ltd.

The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading, injection moulded onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.

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# Tayside Flow Technologies Ltd. Traditional 510(k)

For the ePTFE SLF™ Spiral Vascular Graft

## 510(k) Summary

## Technological Characteristics:

A comparative review of the ePTFE SLF™ Spiral Vascular Grafts with the predicate device found that the technological characteristics, performance and principle of operation were substantially equivalent.

# Performance Data:

Bench testing and animal data demonstrated that the safety and effectiveness of the
ePTFE SLF™ Spiral Vascular Grafts is equivalent to the predicate devices.

#### Safety and Effectiveness:

The ePTFE SLF™ Spiral Vascular Grafts utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate device, the ePTFE SLF™ Spiral Vascular Grafts indicated no adverse indications or results. It is our determination that the ePTFE SLF™ Spiral Vascular Grafts is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

MAR 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tayside Flow Technologies LTD c/o Tayside Flow Technologies LTD 1141 E. Hawken Way Chandler, Arizona 85286 Attention: Mr. Edwin Lindsay

Re: K083169

Trade Name: ePTFE SLF™ Spiral Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: II (two) Product Code: DSY Dated: February 6, 2009 Received: February 11, 2009

Dear Mr. Lindsay:

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, 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 (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.

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.

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Page 2 - Mr. Edwin Lindsay

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

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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# Indications for Use

510(k) Number (if known):_K083169

Device Name: ePTFE SLFTM Spiral Vascular Graft

Indications For Use:

The ePTFE SLF™ Spiral Vascular Graft is indicated for ruse as a vascular prosthesis. It is intended for use in the bypass of reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duver & Vochmer
(Division Sign-Off)

Page 1 of 1

Division of Cardiovascular Devices

510(K) Nell, ber_