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

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

Device 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

AI/ML Overview

This document is a 510(k) Summary for a medical device modification, specifically for the Spiral Flow™ Peripheral Vascular Graft. It primarily describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information like sample sizes, expert qualifications, or details about ground truth.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states:
"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"
This indicates that there were specifications (acceptance criteria) that the device had to meet, and that it did meet or exceed them, but the specific criteria and the actual performance values are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document mentions "Product Testing - Characterisation Study" and "Product Testing Flow Testing Study" but does not detail the sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/provided. This document describes the modification of a physical medical device (vascular graft), not an AI-powered diagnostic device that would require human expert-established ground truth for performance evaluation in the typical sense. The testing mentioned is "non-clinical tests" like biocompatibility, characterization, and flow testing, which are laboratory/engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided for the same reasons as point 3.

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 information is not applicable/provided. This is a physical device, not an AI system for diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable/provided as it is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

This information is not applicable/provided in the context of diagnostic AI. For non-clinical device testing, "ground truth" would typically refer to established scientific/engineering standards, reference measurements, or predefined physical properties that the device's performance is compared against. However, the document does not specify these details.

8. The sample size for the training set:

This information is not applicable/provided as this is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established:

This information is not applicable/provided as this is not an AI/machine learning device.

In summary:

The provided document is a 510(k) summary for a medical device (vascular graft) modification. It confirms that non-clinical testing was performed to demonstrate substantial equivalence to a predicate device. While it states that the modified device "met or exceeded the same specifications as that of the predicate device," it does not provide the specific acceptance criteria or detailed study data that would be required to complete the requested table and answer many of the specific questions about clinical study design, expert involvement, or AI performance metrics. This document focuses on regulatory approval through substantial equivalence based on engineering and material performance rather than clinical efficacy or AI performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2015

Vascular Flow Technologies Ltd. Edwin Lindsay VP of Quality and Regulatory Prospect Business Centre Gemini Crescent, Dundee. DD2 1TY United Kingdom

Re: K150389

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: April 3, 2015 Received: April 10, 2015

Dear Mr. Lindsay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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

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Page 2 - Edwin Lindsay

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 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,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150389

Device Name Spiral Flow™ Peripheral Vascular Graft

Indications for Use (Describe)

The Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 Reqistration Number:

3007676031

Contact Person:

Edwin Lindsay VP of QA/RA Vascular Flow Technologies Limited

Telephone +44 (0) 7917134922

Date Prepared:

12th February 2015

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Vascular Flow Technologies Ltd. Special 510(k): Device Modification

For the Spiral Flow™ Peripheral Vascular 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

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.

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) numbers K083169 and K142062.

Device Description:

The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).

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Vascular Flow Technologies Ltd. Special 510(k): Device Modification

For the Spiral Flow™ Peripheral Vascular Graft

510(k) Summary

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

Regulation Number and Section

§ 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.”