(82 days)
Not Found
No
The summary describes a physical vascular graft with a specific design to induce spiral laminar flow. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and hemodynamic properties, not algorithmic performance.
Yes
The device is a vascular prosthesis intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis, which is a therapeutic intervention.
No
The device is a vascular prosthesis intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical vascular graft made from ePTFE and polyurethane, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states this device is a "vascular prosthesis" intended for use as a "subcutaneous arteriovenous conduit for vascular access during hemodialysis." This is a surgically implanted device used to facilitate a medical procedure (hemodialysis), not to analyze a specimen outside the body.
- Intended Use: The intended use is for creating a vascular access point for hemodialysis, which is a treatment procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, reagents, or diagnostic assays.
This device is a medical device, specifically a vascular graft, but it falls under the category of implanted devices used for treatment, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DSY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forearm, upper arm, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Biocompatibility testing was determined based on ISO 10993 Part 1 (and Annex A), and the fact that the materials are well-characterized and approved for long-term vascular implants.
- Tests specified in ISO 10993 parts 4, 5, 6, 10, 11, and 13 were performed in compliance with GLP, confirming biocompatibility for intended use.
- Further supported by clinical use history of materials and prior FDA clearances for vascular graft use.
Performance Testing:
- Determination of optimum configuration based on:
- Clinical Literature Review (Appendix B)
- Computational Fluid Dynamics (CFD)
- Flow rig work
- Design areas evaluated: Helical angle, Number of ridges, Height of ridge, Ridge profile, Graft profile in polyester.
- Good correlation of CFD data, flow rig data, and in vivo data confirmed suitability of the design.
Haemodynamic Testing: Effect of Diameter:
- In-house flow rig and computational fluid dynamic work carried out to verify that 6mm and 8mm grafts have comparable blood flow characteristics, as both diameters are common for arteriovenous access.
Physical Testing:
- Characterisation and Physical testing carried out to ISO 7198 Cardiovascular implants - tubular vascular prosthesis.
- Tests included: Water permeability, Circumferential tensile strength, 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.
- Test results demonstrate sufficient strength and physical properties for intended performance under in vivo conditions.
Animal Testing (Development of SLF grafts):
- HSAW (100): 6 Months, Mini-Pig, Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm, 8 per group.
- HSAW (103): 1 Week, Mini-Pig, Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm, 1 per group.
- HSAW (104): 1 Month, Mini-Pig, Bard Control vs. Bard+TFT Spiral vs. TFT (McMurry) POLYESTER 8 mm, 2 per group, Purpose: Blood flow Model Development.
- NPIMR (pilot): 1 Month, Sheep, TFT (McMurry) POLYESTER 8 mm, 1 per group.
- NPIMR (SH-02): 3 Month, Sheep, Bard Control vs. Bard+TFT Spiral POLYESTER 8 mm Model Development, 5 per group.
- CHUM (TFT-CHUM pilot) TFT-8-004: 2 Weeks, Dog, Bard Control vs. TFT (McMurry) POLYESTER 8 mm, 2 per group, Purpose: Blood flow Model Development AND Safety.
- CHUM (TFT-8-005): 6 Weeks, Dog, Bard Control vs. TFT (McMurry) POLYESTER 8 mm, 2 per group, Purpose: Study Development.
- CHUM and MHI (TFT-8-006): 20 Weeks, Dog, Bard Control vs. TFT (McMurry) POLYESTER 8 mm, 10 per group, Purpose: Safety Study/Proof of principle and Performance.
- TFT-8-007: 14 Weeks, Sheep, BARD ePTFE 8mm, 2 per group, Purpose: Proof of principle study.
- NPIMR (SH03): 2 Weeks, Sheep, 4 mm Polyester Spiral Grafts, 4 per group, Purpose: Proof of principle study (Performance Study 4 mm Vascular Grafts).
- G0003-09: 2 Weeks, Pig, 6mm ePTFE Spiral Access Grafts v 6mm ePTFE Control Access Grafts, 2 per group, Purpose: Proof of principle study (Performance Study 6 mm Vascular Grafts).
Safety and Effectiveness:
The TFT SLF™ Vascular Arteriovenous Graft indicated no adverse indications or results based on testing and comparison with predicate devices. Determined to be safe, effective, and performs within design specifications, and is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051312, K060741, K052282, K924360, K043552
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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
Number | Device Name | Device
Class | Product
Code | Classification
Panel |
|----------------------|---------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 870.3450 | Prosthesis, Vascular Graft,
Of 6mm And Greater
Diameter | Class 2 | DSY | Cardiovascular |
| 870.3450 | Prosthesis, Vascular Graft,
Of Less Then 6mm
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:
TFT SLF™
Vascular
Arteriovenous
Graft | TFT SLF™
Vascular
Peripheral
Graft | Veryan Medical
SwirlGraft™
Vascular Access Graft | Bard Venaflo
Vascular
Access Graft | Bard IMPRA
CenterFlex
Vascular Access
Graft | Vascutek
Arteriovenous
Graft |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|
| Device
Manufacturer | Tayside Flow
Technologies
Ltd | Tayside Flow
Technologies
Ltd | Veryan Medical
Ltd. | Bard IMPRA | Bard IMPRA | Vascutek Ltd. |
| Device Trade
Name | Spiral Laminar
Flow™
Vascular
Arteriovenous
Graft | Spiral Laminar
Flow™
Vascular
Peripheral Graft | SwirlGraft™
Vascular Access
Graft | Venaflo™ II
Vascular Graft | IMPRA CenterFlex
Grafts | Maxiflo With
PTFE Support
Seal PTFE with
PTFE Support |
| 510(K) Number | N/A | K083169 | K051312/
K060741 | K052282 | K924360 | K043552 |
| Device
Common
Name | ePTFE
Vascular Graft
with SLF™ | ePTFE
Vascular Graft
with SLF™ | ePTFE Vascular
Graft | ePTFE
Vascular Graft
Prosthesis | ePTFE Vascular
Graft Prosthesis | ePTFE Vascular
Graft Prosthesis |
| Device
Classification
name | Prosthesis,
Vascular Graft,
Of 6mm and
Greater
Diameter
and
Prosthesis,
Vascular Graft,
Of Less Then
6mm Diameter | Prosthesis,
Vascular Graft,
Of 6mm and
Greater
Diameter
and
Prosthesis,
Vascular Graft,
Of Less Then
6mm Diameter | Prosthesis,
Vascular Graft,
Of 6mm and
Greater
Diameter | Prosthesis,
Vascular
Graft, Of 6mm
and Greater
Diameter | Prosthesis, Vascular
Graft, Of 6mm and
Greater Diameter | Prosthesis,
Vascular Graft, Of
6mm and Greater
Diameter |
| Device
Classification | Class II | Class II | Class II | Class II | Class II | Class II |
| Materials | ePTFE and PU | ePTFE, PTFE
and PU | ePTFE | ePTFE and
PTFE | ePTFE and PTFE | ePTFE and PTFE |
| Tube | External spiral
inducer 6cm
long at the
distal end of
tube | External spiral
inducer 10cm
long at the
distal end of
tube | Small amplitude
helical geometry
along the tube
length | Straight tube
distal end
diameter
radially
expanded | Straight tube | Straight tube |
| Beading | No | Yes | No | Partial
beading
optional | Partial beading
optional | Yes |
| Distal End
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
arteriovenous | Bypass or
reconstruction | Subcutaneous | Subcutaneous | Subcutaneous | Creation of
subcutaneous |
3
For the Spiral Laminar Flow™ Vascular Anteriovenous Graft 510(k) Summary
| Property | New Device:
TFT SLFTM
Vascular
Arteriovenous
Graft | TFT SLFTM
Vascular
Peripheral
Graft | Veryan Medical
SwirlGraftTM
Vascular
Access Graft | Bard Venaflo
Vascular
Access Graft | Bard IMPRA
CenterFlex
Vascular Access
Graft | Vascutek
Arteriovenous
Graft |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | conduits for
hemodialysis
access | of occluded or
diseased
peripheral
arterial blood
vessels. | conduit for
vascular access. | conduits for
blood access
only | conduits for blood
access only | arteriovenous
conduits for blood
access, bypass or
reconstruction of
occluded or
diseased arterial
blood vessels |
| Intended
Location of
Use | Forearm,
upper arm,
thigh | Either above or
below the knee | Forearm, upper
arm, thigh | Forearm,
upper arm.
thigh | Forearm, upper arm,
thigh | Forearm, upper
arm, thigh, below
knee |
| Device
Description | An ePTFE
graft with a
pre-trimmed
cuff and unique
SLFTM external
spiral flow
inducer and
inducer
indicator made
from Medical
Grade
polyurethane
(PU) at the
distal end . | An ePTFE
supported graft
with a pre-
trimmed cuff
and and unique
SLFTM external
spiral made
from Medical
Grade
polyurethane
(PU) at the
distal end. | A 6mm
expanded
ePTFE vascular
graft that is
manufactured
with a small
amplitude helical
geometry along
its entire length.
The Swirl Graft
Vascular Access
Graft is a
standard wall
ePTFE
construction with
no external
support. | An expanded
ePTFE
vascular graft
with a radially
expanded pre-
formed venous
cuff at the
distal end.
The grafts are
available in
various
lengths and
diameters, in
straight,
stepped and
tapered
configurations,
with and
without
external
support and
with or without
a carbon lining | An expanded
ePTFE vascular
graft
The grafts are
available in various
lengths and
diameters, in
straight, tapered and
stepped
configurations, with
and without external
support and with or
without a carbon
lining | A supported or
unsupported
ePTFE vascular
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:
-
- 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
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
Recovery
Study | Species Used | Description | Number In
Each Group | Purpose |
|----------------------------------------|--------------------------------|--------------|----------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------|
| HSAW (100) | 6 Months | Mini-Pig | Bard Control vs.
Bard+TFT Spiral
POLYESTER 8 mm | 8 | |
| HSAW (103) | 1 Week | Mini-Pig | Bard Control vs.
Bard+TFT Spiral
POLYESTER 8 mm | 1 | |
| HSAW (104) | 1 Months | Mini-Pig | Bard Control vs.
Bard+TFT Spiral vs.
TFT (McMurry)
POLYESTER 8 mm | 2 | Blood flow
Model
Development |
| NPIMR (pilot) | 1 Month | Sheep | TFT (McMurry)
POLYESTER 8 mm | 1 | |
| NPIMR (SH-
02) | 3 Month | Sheep | Bard Control vs.
Bard+TFT Spiral
POLYESTER 8 mm
Model Development | 5 | |
| CHUM (TFT-
CHUM pilot)
TFT-8-004 | 2 Weeks | Dog | Bard Control vs. TFT
(McMurry)
POLYESTER 8 mm | 2 | Blood flow
Model
Development
AND Safety |
| CHUM (TFT-
8-005) | 6 Weeks | Dog | Bard Control vs. TFT
(McMurry)
POLYESTER 8 mm | 2 | Study
Development |
| CHUM and
MHI
(TFT-8-006) | 20 Weeks | Dog | Bard Control vs. TFT
(McMurry)
POLYESTER
8 mm | 10 | Safety Study/
Proof of
principle and
Performance |
| TFT-8-007 | 14 Weeks | Sheep | BARD ePTFE
8mm | 2 | Proof of
principle
study |
6
For the Spiral Laminar Flow™ Vascular Arteriovenous Graft 510(k) Summary
| STUDY | Length of
Recovery Study | Species Used | Description | Number In
Each Group | Purpose |
|-----------------|-----------------------------|--------------|---------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------|
| NPIMR
(SH03) | 2 Weeks | Sheep | 4 mm Polyester Spiral
Grafts | 4 | Proof of
principle study
(Performance
Study 4 mm
Vascular
Grafts) |
| G0003-09 | 2 Weeks | Pig | 6mm ePTFE Spiral
Access Grafts v 6mm
ePTFE Control
Access Grafts | 2 | Proof of
principle study
(Performance
Study 6 mm
Vascular
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)
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_ko94044