(82 days)
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.
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.
The description below is based on the provided text, which details a 510(k) submission for a medical device seeking substantial equivalence, rather than a study designed to meet specific performance acceptance criteria for an AI/ML device. Therefore, many standard fields for AI/ML study descriptions (e.g., sample size for test sets, number of experts, adjudication methods) are not applicable or cannot be extracted from this type of document.
The document describes the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft and its path to 510(k) clearance by demonstrating substantial equivalence to predicate devices, rather than meeting specific performance acceptance criteria in the format typically seen for AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a vascular graft, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to already cleared predicate devices through a comparison of technological characteristics, performance data (bench and animal testing), and materials. There aren't explicit numerical "acceptance criteria" presented in the document in the way one might see for an AI/ML diagnostic device with performance metrics (e.g., sensitivity, specificity).
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates across various physical, mechanical, and biological properties.
| Criterion Category | Implicit Acceptance Criterion (Substantial Equivalence) | Reported Device Performance / Evidence |
|---|---|---|
| Technological Characteristics | The new device's technological characteristics, performance, and principle of operation are substantially equivalent to predicate devices. | A comparative review found substantial equivalence. The detailed comparison table (Pages 2-3) shows similar materials (ePTFE and PU, compared to ePTFE and PTFE in predicates), device classification, common name, and intended use. The key difference is the "External spiral inducer 6cm long at the distal end of tube" for the new device, compared to "helical geometry" or "straight tube" in predicates, but this design is intended to induce spiral laminar flow. |
| Biocompatibility | The materials used and the device itself are biocompatible for long-term vascular implantation. | - Testing: Based on ISO 10993 parts 4, 5, 6, 10, 11, and 13, performed in compliance with GLP. Confirmed sufficient biocompatibility. - Prior Use: Materials (ePTFE and ChronoFlex® C-80A polyurethane) are well-characterized and approved for long-term vascular implants, with a list of 510(k) cleared devices using these materials provided in section 11 (not explicitly in provided text). - Both materials cleared by FDA for vascular graft use. |
| Performance Testing (Fluid Dynamics) | The design (helical angle, number/height/profile of ridges) promotes intended flow characteristics (spiral laminar flow). | - Methodologies: Literature review, computational fluid dynamics (CFD), and flow rig work were used to determine optimum configuration. - Correlation: "Good correlation of CFD data, flow rig data and in vivo data confirmed the suitability of the design." - Haemodynamic Testing (Diameter): In-house flow rig and CFD work confirmed 6mm and 8mm grafts have comparable blood flow characteristics. |
| Physical Testing | The device possesses sufficient physical and mechanical strength and properties to perform as intended under in vivo conditions. | - Testing to ISO7198: Water permeability, circumferential tensile strength, longitudinal tensile strength, probe burst strength, usable length, relaxed internal diameter, wall thickness, pressurized internal diameter, suture retention strength, kink diameter/radius, dynamic compliance. - Result: "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 (Safety & Performance) | The device is safe, effective, and performs comparably to controls/predicates in an in vivo setting. | - A series of animal studies (HSAW, NPIMR, CHUM, TFT-8-007, NPIMR (SH03), G0003-09) were conducted using mini-pigs, sheep, and dogs. - These studies covered various durations (1 week to 20 weeks) and purposes, including blood flow model development, safety studies, and proof of principle/performance. - Overall Conclusion: "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." |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" for this submission would be considered the various experimental conditions across the bench and animal studies.
- Bench Testing (Physical & Fluid Dynamics): Details on the specific sample sizes for each physical test (e.g., how many grafts were tested for tensile strength) are not provided in the summary. For CFD and flow rig work, these are experimental setups, not human patient data.
- Animal Testing: The "Number in Each Group" is provided for each animal study (see table on Pages 5-6). For example:
- HSAW (100): 8 mini-pigs
- CHUM and MHI (TFT-8-006): 10 dogs (for Safety Study/Proof of principle and Performance)
- G0003-09: 2 pigs (for Proof of principle study of 6mm ePTFE grafts)
- Data Provenance: The animal studies were conducted by various institutions (e.g., HSAW, NPIMR, CHUM, MHI, TFT). While the text doesn't explicitly state the country, the submitting company is based in Scotland, and CHUM is a common acronym for Centre hospitalier de l'Université de Montréal in Canada, suggesting international provenance for animal data. These are prospective animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This is a medical device (vascular graft) submission, not an AI/ML diagnostic or measurement device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists interpreting images) is not applicable in the same way. The "ground truth" for the performance of the graft is established through objective physical measurements, detailed flow analysis, and histological/physiological assessments from animal studies, interpreted by qualified scientists and veterinarians involved in those studies. No specific number or qualifications of "experts" are cited for establishing a "ground truth" in the context of interpretation, but rather the studies themselves are the evidence.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1 consensus) is not typically applicable to the evaluation of physical device performance or animal study outcomes in this context. The animal study outcomes would be evaluated based on predefined endpoints, measurements, and potentially histopathological analysis by veterinary pathologists.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is entirely not applicable as the submission is for a physical vascular graft, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is entirely not applicable as the submission is for a physical vascular graft.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Bench Testing: Objective physical measurements against established standards (e.g., ISO7198 for tensile strength, permeability, etc.).
- Computational Fluid Dynamics (CFD) and Flow Rig Work: Mathematical models and physical simulations of fluid flow.
- Animal Studies: In vivo observation of safety (e.g., absence of adverse reactions, patency) and performance (e.g., blood flow characteristics, histological analysis of tissue response) in comparison to control devices, using established scientific and veterinary methods.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device submission. The "development" and "optimization" of the graft design were based on literature review, CFD, flow rig work, and various animal studies, as well as the inherent properties of the ePTFE and polyurethane materials.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" in this context. The "ground truth" for guiding the device's development (analogous to how a training set might guide an AI) was established through existing scientific literature, engineering principles of fluid dynamics, material science data for ePTFE and polyurethane, and early-stage animal studies designed for model development and proof of concept.
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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
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For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary
Device Classification Information:
| RegulationNumber | Device Name | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 870.3450 | Prosthesis, Vascular Graft,Of 6mm And GreaterDiameter | Class 2 | DSY | Cardiovascular |
| 870.3450 | Prosthesis, Vascular Graft,Of Less Then 6mmDiameter | 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.
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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:TFT SLF™VascularArteriovenousGraft | TFT SLF™VascularPeripheralGraft | Veryan MedicalSwirlGraft™Vascular Access Graft | Bard VenafloVascularAccess Graft | Bard IMPRACenterFlexVascular AccessGraft | VascutekArteriovenousGraft |
|---|---|---|---|---|---|---|
| DeviceManufacturer | Tayside FlowTechnologiesLtd | Tayside FlowTechnologiesLtd | Veryan MedicalLtd. | Bard IMPRA | Bard IMPRA | Vascutek Ltd. |
| Device TradeName | Spiral LaminarFlow™VascularArteriovenousGraft | Spiral LaminarFlow™VascularPeripheral Graft | SwirlGraft™Vascular AccessGraft | Venaflo™ IIVascular Graft | IMPRA CenterFlexGrafts | Maxiflo WithPTFE SupportSeal PTFE withPTFE Support |
| 510(K) Number | N/A | K083169 | K051312/K060741 | K052282 | K924360 | K043552 |
| DeviceCommonName | ePTFEVascular Graftwith SLF™ | ePTFEVascular Graftwith SLF™ | ePTFE VascularGraft | ePTFEVascular GraftProsthesis | ePTFE VascularGraft Prosthesis | ePTFE VascularGraft Prosthesis |
| DeviceClassificationname | Prosthesis,Vascular Graft,Of 6mm andGreaterDiameterandProsthesis,Vascular Graft,Of Less Then6mm Diameter | Prosthesis,Vascular Graft,Of 6mm andGreaterDiameterandProsthesis,Vascular Graft,Of Less Then6mm Diameter | Prosthesis,Vascular Graft,Of 6mm andGreaterDiameter | Prosthesis,VascularGraft, Of 6mmand GreaterDiameter | Prosthesis, VascularGraft, Of 6mm andGreater Diameter | Prosthesis,Vascular Graft, Of6mm and GreaterDiameter |
| DeviceClassification | Class II | Class II | Class II | Class II | Class II | Class II |
| Materials | ePTFE and PU | ePTFE, PTFEand PU | ePTFE | ePTFE andPTFE | ePTFE and PTFE | ePTFE and PTFE |
| Tube | External spiralinducer 6cmlong at thedistal end oftube | External spiralinducer 10cmlong at thedistal end oftube | Small amplitudehelical geometryalong the tubelength | Straight tubedistal enddiameterradiallyexpanded | Straight tube | Straight tube |
| Beading | No | Yes | No | Partialbeadingoptional | Partial beadingoptional | Yes |
| Distal EndModification | 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 | Subcutaneousarteriovenous | Bypass orreconstruction | Subcutaneous | Subcutaneous | Subcutaneous | Creation ofsubcutaneous |
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For the Spiral Laminar Flow™ Vascular Anteriovenous Graft 510(k) Summary
| Property | New Device:TFT SLFTMVascularArteriovenousGraft | TFT SLFTMVascularPeripheralGraft | Veryan MedicalSwirlGraftTMVascularAccess Graft | Bard VenafloVascularAccess Graft | Bard IMPRACenterFlexVascular AccessGraft | VascutekArteriovenousGraft |
|---|---|---|---|---|---|---|
| conduits forhemodialysisaccess | of occluded ordiseasedperipheralarterial bloodvessels. | conduit forvascular access. | conduits forblood accessonly | conduits for bloodaccess only | arteriovenousconduits for bloodaccess, bypass orreconstruction ofoccluded ordiseased arterialblood vessels | |
| IntendedLocation ofUse | Forearm,upper arm,thigh | Either above orbelow the knee | Forearm, upperarm, thigh | Forearm,upper arm.thigh | Forearm, upper arm,thigh | Forearm, upperarm, thigh, belowknee |
| DeviceDescription | An ePTFEgraft with apre-trimmedcuff and uniqueSLFTM externalspiral flowinducer andinducerindicator madefrom MedicalGradepolyurethane(PU) at thedistal end . | An ePTFEsupported graftwith a pre-trimmed cuffand and uniqueSLFTM externalspiral madefrom MedicalGradepolyurethane(PU) at thedistal end. | A 6mmexpandedePTFE vasculargraft that ismanufacturedwith a smallamplitude helicalgeometry alongits entire length.The Swirl GraftVascular AccessGraft is astandard wallePTFEconstruction withno externalsupport. | An expandedePTFEvascular graftwith a radiallyexpanded pre-formed venouscuff at thedistal end.The grafts areavailable invariouslengths anddiameters, instraight,stepped andtaperedconfigurations,with andwithoutexternalsupport andwith or withouta carbon lining | An expandedePTFE vasculargraftThe grafts areavailable in variouslengths anddiameters, instraight, tapered andsteppedconfigurations, withand without externalsupport and with orwithout a carbonlining | A supported orunsupportedePTFE vasculargraft |
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:
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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:
-
- Clinical Literature Review (Appendix B)
-
- Helical angle (computational fluid dynamics and flow rig)
-
- 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
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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 ofRecoveryStudy | Species Used | Description | Number InEach Group | Purpose |
|---|---|---|---|---|---|
| HSAW (100) | 6 Months | Mini-Pig | Bard Control vs.Bard+TFT SpiralPOLYESTER 8 mm | 8 | |
| HSAW (103) | 1 Week | Mini-Pig | Bard Control vs.Bard+TFT SpiralPOLYESTER 8 mm | 1 | |
| HSAW (104) | 1 Months | Mini-Pig | Bard Control vs.Bard+TFT Spiral vs.TFT (McMurry)POLYESTER 8 mm | 2 | Blood flowModelDevelopment |
| NPIMR (pilot) | 1 Month | Sheep | TFT (McMurry)POLYESTER 8 mm | 1 | |
| NPIMR (SH-02) | 3 Month | Sheep | Bard Control vs.Bard+TFT SpiralPOLYESTER 8 mmModel Development | 5 | |
| CHUM (TFT-CHUM pilot)TFT-8-004 | 2 Weeks | Dog | Bard Control vs. TFT(McMurry)POLYESTER 8 mm | 2 | Blood flowModelDevelopmentAND Safety |
| CHUM (TFT-8-005) | 6 Weeks | Dog | Bard Control vs. TFT(McMurry)POLYESTER 8 mm | 2 | StudyDevelopment |
| CHUM andMHI(TFT-8-006) | 20 Weeks | Dog | Bard Control vs. TFT(McMurry)POLYESTER8 mm | 10 | Safety Study/Proof ofprinciple andPerformance |
| TFT-8-007 | 14 Weeks | Sheep | BARD ePTFE8mm | 2 | Proof ofprinciplestudy |
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For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary
| STUDY | Length ofRecovery Study | Species Used | Description | Number InEach Group | Purpose |
|---|---|---|---|---|---|
| NPIMR(SH03) | 2 Weeks | Sheep | 4 mm Polyester SpiralGrafts | 4 | Proof ofprinciple study(PerformanceStudy 4 mmVascularGrafts) |
| G0003-09 | 2 Weeks | Pig | 6mm ePTFE SpiralAccess Grafts v 6mmePTFE ControlAccess Grafts | 2 | Proof ofprinciple study(PerformanceStudy 6 mmVascularGrafts) |
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.
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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.
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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
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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)
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_ko94044
§ 870.3450 Vascular graft prosthesis.
(a)
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.(b)
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.”