SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

{0}------------------------------------------------ K०५५०५५ MAR 2 3 2010 . i ## Tayside Flow Technologies Ltd. Traditional 510(k) For the Spiral Laminar Flow™ Vascular Anteriovenous 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 +44 (0) 1382 598 532 Telephone Fax +44 (0) 1382 598 528 Establishment Registration Number: 3007676031 Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 Date Prepared: 18" March 2010 {1}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous 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: Spiral Laminar Flow™ Vascular Arteriovenous Graft ### Device Common Name: ePTFE Vascular Graft with SLF™ ### Intended Use: The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. 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 Tayside Flow Technologies (TFT) Spiral Laminar Flow™ Vascular Arteriovenous Graft is ട്രവിവിച്ചിരിക്കുന്നു. അവലംബം Limited SwitlGraft™ Graft (K051312/K060741), Bard IMPRA Venaflo® Vascular Access Graft (K052282), Bard IMPRA CenterFlex® Vascular Access Graft (K924360) and Vascutek PTFE Supported ePTFE Vascular Prostheses (K043552). ### Device Description: The TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for hemodialysis access. The graft has a specially designed section which is intended to induce spiral laminar flow. This section is designed to propagate spiral flow though the graft and into the distal circulation. TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft. The straight graft is combined with TFT's unique SLF™ external spiral flow inducer and inducer indicator, both made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane. The inducer indicator is a palpable ring over the proximal end of the spiral flow inducer. Its purpose is to indicate to the user where the spiral inducer segment begins since it is intended that cannulation in this segment should be avoided. {2}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft Technological Characteristics: A comparative review of the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft with the predicate devices found that the technological characteristics, performance and principle of operation were substantially equivalent. A comparison is presented in the table below: | Property | New Device:<br>TFT SLF™<br>Vascular<br>Arteriovenous<br>Graft | TFT SLF™<br>Vascular<br>Peripheral<br>Graft | Veryan Medical<br>SwirlGraft™<br>Vascular Access Graft | Bard Venaflo<br>Vascular<br>Access Graft | Bard IMPRA<br>CenterFlex<br>Vascular Access<br>Graft | Vascutek<br>Arteriovenous<br>Graft | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------| | Device<br>Manufacturer | Tayside Flow<br>Technologies<br>Ltd | Tayside Flow<br>Technologies<br>Ltd | Veryan Medical<br>Ltd. | Bard IMPRA | Bard IMPRA | Vascutek Ltd. | | Device Trade<br>Name | Spiral Laminar<br>Flow™<br>Vascular<br>Arteriovenous<br>Graft | Spiral Laminar<br>Flow™<br>Vascular<br>Peripheral Graft | SwirlGraft™<br>Vascular Access<br>Graft | Venaflo™ II<br>Vascular Graft | IMPRA CenterFlex<br>Grafts | Maxiflo With<br>PTFE Support<br>Seal PTFE with<br>PTFE Support | | 510(K) Number | N/A | K083169 | K051312/<br>K060741 | K052282 | K924360 | K043552 | | Device<br>Common<br>Name | ePTFE<br>Vascular Graft<br>with SLF™ | ePTFE<br>Vascular Graft<br>with SLF™ | ePTFE Vascular<br>Graft | ePTFE<br>Vascular Graft<br>Prosthesis | ePTFE Vascular<br>Graft Prosthesis | ePTFE Vascular<br>Graft Prosthesis | | Device<br>Classification<br>name | Prosthesis,<br>Vascular Graft,<br>Of 6mm and<br>Greater<br>Diameter<br>and<br>Prosthesis,<br>Vascular Graft,<br>Of Less Then<br>6mm Diameter | Prosthesis,<br>Vascular Graft,<br>Of 6mm and<br>Greater<br>Diameter<br>and<br>Prosthesis,<br>Vascular Graft,<br>Of Less Then<br>6mm Diameter | Prosthesis,<br>Vascular Graft,<br>Of 6mm and<br>Greater<br>Diameter | Prosthesis,<br>Vascular<br>Graft, Of 6mm<br>and Greater<br>Diameter | Prosthesis, Vascular<br>Graft, Of 6mm and<br>Greater Diameter | Prosthesis,<br>Vascular Graft, Of<br>6mm and Greater<br>Diameter | | Device<br>Classification | Class II | Class II | Class II | Class II | Class II | Class II | | Materials | ePTFE and PU | ePTFE, PTFE<br>and PU | ePTFE | ePTFE and<br>PTFE | ePTFE and PTFE | ePTFE and PTFE | | Tube | External spiral<br>inducer 6cm<br>long at the<br>distal end of<br>tube | External spiral<br>inducer 10cm<br>long at the<br>distal end of<br>tube | Small amplitude<br>helical geometry<br>along the tube<br>length | Straight tube<br>distal end<br>diameter<br>radially<br>expanded | Straight tube | Straight tube | | Beading | No | Yes | No | Partial<br>beading<br>optional | Partial beading<br>optional | Yes | | Distal End<br>Modification | Yes | Yes | No | Yes | No | No | | Diameter | 5, 6 and 7mm | 5, 6, 7 and 8mm | 6mm | 6, 7 and 8mm | 6, 7 and 8mm | 6, 7 8 and 10 mm | | Intended Use | Subcutaneous<br>arteriovenous | Bypass or<br>reconstruction | Subcutaneous | Subcutaneous | Subcutaneous | Creation of<br>subcutaneous | {3}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Anteriovenous Graft 510(k) Summary | Property | New Device:<br>TFT SLFTM<br>Vascular<br>Arteriovenous<br>Graft | TFT SLFTM<br>Vascular<br>Peripheral<br>Graft | Veryan Medical<br>SwirlGraftTM<br>Vascular<br>Access Graft | Bard Venaflo<br>Vascular<br>Access Graft | Bard IMPRA<br>CenterFlex<br>Vascular Access<br>Graft | Vascutek<br>Arteriovenous<br>Graft | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | | conduits for<br>hemodialysis<br>access | of occluded or<br>diseased<br>peripheral<br>arterial blood<br>vessels. | conduit for<br>vascular access. | conduits for<br>blood access<br>only | conduits for blood<br>access only | arteriovenous<br>conduits for blood<br>access, bypass or<br>reconstruction of<br>occluded or<br>diseased arterial<br>blood vessels | | Intended<br>Location of<br>Use | Forearm,<br>upper arm,<br>thigh | Either above or<br>below the knee | Forearm, upper<br>arm, thigh | Forearm,<br>upper arm.<br>thigh | Forearm, upper arm,<br>thigh | Forearm, upper<br>arm, thigh, below<br>knee | | Device<br>Description | An ePTFE<br>graft with a<br>pre-trimmed<br>cuff and unique<br>SLFTM external<br>spiral flow<br>inducer and<br>inducer<br>indicator made<br>from Medical<br>Grade<br>polyurethane<br>(PU) at the<br>distal end . | An ePTFE<br>supported graft<br>with a pre-<br>trimmed cuff<br>and and unique<br>SLFTM external<br>spiral made<br>from Medical<br>Grade<br>polyurethane<br>(PU) at the<br>distal end. | A 6mm<br>expanded<br>ePTFE vascular<br>graft that is<br>manufactured<br>with a small<br>amplitude helical<br>geometry along<br>its entire length.<br>The Swirl Graft<br>Vascular Access<br>Graft is a<br>standard wall<br>ePTFE<br>construction with<br>no external<br>support. | An expanded<br>ePTFE<br>vascular graft<br>with a radially<br>expanded pre-<br>formed venous<br>cuff at the<br>distal end.<br>The grafts are<br>available in<br>various<br>lengths and<br>diameters, in<br>straight,<br>stepped and<br>tapered<br>configurations,<br>with and<br>without<br>external<br>support and<br>with or without<br>a carbon lining | An expanded<br>ePTFE vascular<br>graft<br>The grafts are<br>available in various<br>lengths and<br>diameters, in<br>straight, tapered and<br>stepped<br>configurations, with<br>and without external<br>support and with or<br>without a carbon<br>lining | A supported or<br>unsupported<br>ePTFE vascular<br>graft | ### Performance Data: Bench testing and animal data demonstrated that the safety and effectiveness of the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is equivalent to the predicate devices. - . Biocompatibility Testing Tayside Flow Technologies (TFT) Spiral Laminar Flow™ Vascular Arteriovenous Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE). The unique SLF™ spiral flow inducer and inducer indicator are injection molded onto the outer surface of the straight graft. The inducer and indicator are made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane, further information is available in as section 11. To determine the biocompatibility testing required for the TFT graft materials the following was taken into account: {4}------------------------------------------------ ### For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary - The requirements of ISO 10993 Part1 and especially Annex A of this part which . provides guidance on the selection of tests - The fact that the materials used in the TFT graft are already well-characterised and . are approved for use as long-term vascular implants. Section 11 includes a list of vascular devices which make use of these materials and which are 510(k) cleared. Based on this analysis it was determined that the tests specified in the following parts of ISO 10993 were appropriate: parts 4, 5, 6, 10, 11 and 13. These tests performed in compliance with GLP, confirmed that the biocompatibility of the Spiral Laminar Flow™ Vascular Arteriovenous Graft is sufficient for their intended use. These test results are further supported by the fact that these materials have been in clinical use in implant applications for many years with good results. Further proof of the biocompatibility of the materials used in the TFT graft was provided by the fact that both the materials used have been cleared by FDA for vascular graft use as already mentioned. The details of the 510(k)s are given in section 11. #### Performance Testing . The determination of the optimum configuration for the TFT graft was based on 1) a literature review, 2) computational fluid dynamics (CFD) and 3) flow rig work. A number of design areas were evaluated: - 1. Clinical Literature Review (Appendix B) - 2. Helical angle (computational fluid dynamics and flow rig) - 3. Number of ridges (computational fluid dynamics and flow rig) - Height of ridge (computational fluid dynamics and flow rig) ধ - Ridge profile (computational fluid dynamics and flow rig) u - Graft profile in polyester (flow rig) 6. Good correlation of CFD data, flow rig data and in vivo data confirmed the suitability of the design. ### Haemodynamic Testing: Effect of Diameter As 6mm and 8mm grafts are commercially available for infrainguinal bypass, there is no 'industry standard' as far as diameter is concerned. However, 6mm through 8mm grafts are commonly used for arteriovenous access. To verify that 6mm and 8mm grafts have comparable blood flow characteristics, in-house flow rig and computational fluid dynamic work has been carried out. ### Physical Testing Characterisation and Physical testing has been carried out to ISO7198 Cardiovascular implants - tubular vascular prosthesis. This includes :- - . Water permeability - Circumferential tensile strength {5}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary - Longitudinal tensile strength . - Probe burst strength . - Usable length of formed material . - Relaxed internal diameter . - . Wall thickness - . Pressurised internal diameter - . Suture retention strength - . Kink diameter / radius - . Dynamic compliance The test results demonstrate that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft has sufficient strength and physical properties to perform as intended under the expected in vivo loading conditions. ### Animal Testing ### Development of SLF grafts TFT has completed the following animal studies during the development of the TFT Spiral Laminar Flow™ ePTFE Vascular Grafts. | STUDY | Length of<br>Recovery<br>Study | Species Used | Description | Number In<br>Each Group | Purpose | |----------------------------------------|--------------------------------|--------------|----------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------| | HSAW (100) | 6 Months | Mini-Pig | Bard Control vs.<br>Bard+TFT Spiral<br>POLYESTER 8 mm | 8 | | | HSAW (103) | 1 Week | Mini-Pig | Bard Control vs.<br>Bard+TFT Spiral<br>POLYESTER 8 mm | 1 | | | HSAW (104) | 1 Months | Mini-Pig | Bard Control vs.<br>Bard+TFT Spiral vs.<br>TFT (McMurry)<br>POLYESTER 8 mm | 2 | Blood flow<br>Model<br>Development | | NPIMR (pilot) | 1 Month | Sheep | TFT (McMurry)<br>POLYESTER 8 mm | 1 | | | NPIMR (SH-<br>02) | 3 Month | Sheep | Bard Control vs.<br>Bard+TFT Spiral<br>POLYESTER 8 mm<br>Model Development | 5 | | | CHUM (TFT-<br>CHUM pilot)<br>TFT-8-004 | 2 Weeks | Dog | Bard Control vs. TFT<br>(McMurry)<br>POLYESTER 8 mm | 2 | Blood flow<br>Model<br>Development<br>AND Safety | | CHUM (TFT-<br>8-005) | 6 Weeks | Dog | Bard Control vs. TFT<br>(McMurry)<br>POLYESTER 8 mm | 2 | Study<br>Development | | CHUM and<br>MHI<br>(TFT-8-006) | 20 Weeks | Dog | Bard Control vs. TFT<br>(McMurry)<br>POLYESTER<br>8 mm | 10 | Safety Study/<br>Proof of<br>principle and<br>Performance | | TFT-8-007 | 14 Weeks | Sheep | BARD ePTFE<br>8mm | 2 | Proof of<br>principle<br>study | {6}------------------------------------------------ For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary | STUDY | Length of<br>Recovery Study | Species Used | Description | Number In<br>Each Group | Purpose | |-----------------|-----------------------------|--------------|---------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------| | NPIMR<br>(SH03) | 2 Weeks | Sheep | 4 mm Polyester Spiral<br>Grafts | 4 | Proof of<br>principle study<br>(Performance<br>Study 4 mm<br>Vascular<br>Grafts) | | G0003-09 | 2 Weeks | Pig | 6mm ePTFE Spiral<br>Access Grafts v 6mm<br>ePTFE Control<br>Access Grafts | 2 | Proof of<br>principle study<br>(Performance<br>Study 6 mm<br>Vascular<br>Grafts) | ### Safety and Effectiveness: The TFT SLF™ Vascular Arteriovenous Graft utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the TFT SLFTM Vascular Arteriovenous Graft indicated no adverse indications or results. It is our determination that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device. {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Tayside Flow Technologies LTD c/o Mr. Rudy Mounia 1141 E. Hawken Way Chandler, AZ 85286 ## MAR 2 3 2010 Re: K094044 Trade Name: Spiral Laminar Flow™M Vascular Arteriovenous Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: II (two) Product Code: DSY Dated: December 28, 2009 Received: December 31, 2009 Dear Mr. Mounia: .. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {8}------------------------------------------------ Page 2 - Mr. Rudy Mounia 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Dma R. Vi. Amer Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Tayside Flow Technologies Ltd. Traditional 510(k) For the Spiral Laminar Flow™ Vascular Arteriovenous Graft ### Indications for Use 510(k) Number (if known): 《0 9 40 4-4 Device Name: Spiral Laminar Flow™ Vascular Arteriovenous Graft Indications for Use: The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. 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, Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ~~~~~~~~~ R ~~~~~~~~ (Division Sign-Off) Division of Cardiovascular Devices Page 1 of 1 510(k) Number_ko94044