(113 days)
Not Found
No
The description focuses on the physical design and material properties of the graft to induce spiral flow, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "vascular prostheses" and is intended for use in the "bypass or reconstruction of occluded or diseased peripheral arterial blood vessels," which are therapeutic interventions.
No
The device is a vascular prosthesis intended for bypass or reconstruction of blood vessels. It does not perform any diagnostic function.
No
The device description clearly outlines a physical vascular graft made from ePTFE and PTFE, with injection-molded components. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a vascular prosthesis for bypass or reconstruction of peripheral arterial blood vessels. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical graft made from ePTFE and polyurethane, designed to be implanted in the body. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological specimen. The device's function is mechanical (providing a conduit for blood flow) and potentially hemodynamic (inducing spiral flow).
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spiral Flow Peripheral 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.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
Vascular Flow Technologies' (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee; it has a specially designed section to induce spiral laminar flow.
The unique design feature translates Spiral Laminar Flow (SLF™) technology to the graft lumen profile. SLF™ technology is designed to propagate spiral flow though the graft and into the distal circulation.
The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).
The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading over most of the grafts length. This is heat set onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.
The unique SLF™ spiral flow inducer is 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arterial blood vessels above or below the knee.
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)
The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivelance to the predicate device:
- . Biocompatibility Review
- . Product Testing - Characterisation Study
- Product Testing Flow Testing Study ●
- . Sterilisation Validation
Conclusion:
The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Vascular Flow Technologies Ltd. Edwin Lindsay VP of QA/RA Prospect Business Centre, Gemini Cresent Dundee DD2 1TY United Kingdom
Re: K142062
Trade/Device Name: Spiral Flow Peripheral Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY Dated: October 28, 2014 Received: October 29, 2014
Dear Edwin 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. 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.
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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
M.A. Hilleman
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142062
Device Name Spiral Flow™ Peripheral Vascular Graft
Indications for Use (Describe)
The Spiral Flow Peripheral 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.
ONL Y 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Vascular Flow Technologies Ltd. Special 510(k): Device Modification
For the Spiral Flow™ Peripheral Vascular Graft
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
Vascular Flow Technologies Limited
Submitter's Address:
Vascular Flow Technologies Limited Prospect Business Centre, Gemini Crescent, Dundee, DD2 1TY UK
Tel: +44 (0) 1382 598 532
Establishment Registration Number:
3007676031
Contact Person:
Edwin Lindsay VP of QA/RA Vascular Flow Technologies Limited
Telephone +44 (0) 7917134922
Date Prepared:
25" July 2014
4
Vascular Flow Technologies Ltd. Special 510(k): Device Modification
For the Spiral Flow™ Peripheral Vascular 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 |
Device Trade Name:
Spiral Flow™ Peripheral Vascular Graft
Device Common Name:
Spiral Flow™ Peripheral Vascular Graft
Intended Use:
The Spiral Flow Peripheral 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.
Predicate Device:
The modified device is substantially equivalent to the previously cleared Spiral Flow Peripheral Vascular Grafts, 510(k) number K083169
Device Description:
Vascular Flow Technologies' (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee; it has a specially designed section to induce spiral laminar flow.
The unique design feature translates Spiral Laminar Flow (SLF™) technology to the graft lumen profile. SLF™ technology is designed to propagate spiral flow though the graft and into the distal circulation.
The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).
The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading over most of the grafts length. This is heat set onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.
5
Vascular Flow Technologies Ltd. Special 510(k): Device Modification
For the Spiral Flow™ Peripheral Vascular Graft
510(k) Summary
The unique SLF™ spiral flow inducer is 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
Comparison to Predicate Device
In comparison to the predicate device, the subject device has a new base ePTFE graft material. This modification does not affect the intended use of the device or alter the fundamental scientific technology of the device.
Summary of non-clinical tests:
The following outlines the testing performed, as a result of the risk analysis, to demonstrate substantial equivelance to the predicate device:
- . Biocompatibility Review
- . Product Testing - Characterisation Study
- Product Testing Flow Testing Study ●
- . Sterilisation Validation
Conclusion:
The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device