Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.
Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.
Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.

Device Description

Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.
The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.

AI/ML Overview

The provided document is a 510(k) Summary for the Vascutek Gelweave™ Vascular Grafts. It discusses substantial equivalence to previously marketed devices and the non-clinical testing performed. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies of a medical device AI/ML algorithm.

The document pertains to a physical medical device (Gelweave Vascular Grafts) and its material change (new gelatin supplier), not an AI/ML system. Therefore, details like AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

In summary, none of the requested information to describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device is available in the provided text.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

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

June 30, 2017

Vascutek Ltd. Neil McLachlan Head of Regulatory Affairs Newmains Avenue. Inchinnan Renfrewshire, PA4 9RR United Kingdom

Re: K162794

Trade/Device Name: Gelweave Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY Dated: May 31, 2017 Received: June 5, 2017

Dear Mr. McLachlan:

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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.

Nicole G. Ibrahim -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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510(k) Number (if known) K162794

Device Name Gelweave Vascular Grafts

Indications for Use (Describe)

Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

|× | 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

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510(k) Number (if known) K162794

Device Name

Gelweave Vascular Grafts (Bifurcated Configuration)

Indications for Use (Describe)

Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

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.

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

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510(k) Number (if known) K162794

Device Name Gelweave Valsalva Vascular Grafts

Indications for Use (Describe)

Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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.

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

{5}------------------------------------------------

510(k) Number (if known) K162794

Device Name

Gelweave Branched Vascular Prostheses with or without Radiopaque Markers

Indications for Use (Describe)

Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.

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.

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

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510(k) Number (if known) K162794

Device Name

Gelweave Collared Ante-Flo and Plexus Vascular Prostheses (with and without Radiopaque Markers)

Indications for Use (Describe)

Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.

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.

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

{7}------------------------------------------------

510(k) Number (if known) K162794

Device Name

Gelweave Branched Vascular Prostheses, including Siena™ Vascular Prostheses

Indications for Use (Describe)

Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures.

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.

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

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Image /page/8/Picture/0 description: The image shows the logo for "VASCUTEK TERUMO". The word "VASCUTEK" is in gray, with each letter outlined with a double line. To the left of the word is a circle that is split in half, with the left half being blue and the right half being red. The word "TERUMO" is in gray and is located below the word "VASCUTEK".

VASCUTEK Ltd Newmains Avenue, Inchinnan Renfrewshire PA4 9RR, Scotland, UK Tel: +44 (0) 141 812 5555 www.vascutek.com

510(k) Summary

This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.

Submitter:	Vascutek LtdNewmains AvenueInchinnanRenfrewshirePA4 9RRScotland, UK+44 (0) 141 812 555
Contact:	Neil McLachlanHead of Regulatory AffairsTel: +44 141 812 5555Email: N.McLachlan@vascutek.com
Date of Preparation:	29 June 2017
Trade Name:	Vascutek Gelweave™ Vascular Grafts
Common or Usual Name:	Vascular Prosthesis
Classification Name:	Vascular Graft Prosthesis
Review Panel:	Cardiovascular
Product Code:	DSY
Regulation Number:	21 CFR 870.3450
Device Class:	II

ldentification of the legally marketed device to which equivalence is being claimed Vascutek are claiming equivalence to the following legally marketed devices:

Gelweave™ Vascular Grafts (Bifurcated Configuration); K964665 ●

Gelweave Valsalva™ Vascular Grafts; K013022 .
Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque ● Markers; K060142
Gelweave™ Branched Vascular Grafts with Radiopaque Markers; K093817 ●

Device Description

Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.

The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.

K162794

{9}------------------------------------------------

The indications for use of the Gelweave vascular grafts are detailed below.

These are identical to the indications for use of the predicate devices.

Gelweave vascular grafts: "Indicated for thoracic reconstruction procedures for replacement of diseased segments of the thoracic aorta in cases of aneurysm, dissection, or coarctation."

Gelweave vascular grafts (Bifurcated Configuration); "Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease."

Gelweave Valsalva vascular grafts: "Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation."

Gelweave Branched Vascular Prostheses with or without radiopaque markers: "Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation."

Gelweave Collared Ante-Flo and Plexus Vascular Prostheses (with and without radiopaque markers): "Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation."

Gelweave Branched Vascular Prostheses, including Siena™ Vascular Prostheses: "Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures." Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.

Technological Characteristics

Equivalency is based on identical design, technology, construction and intended use.

The only change is that the gelatin used to seal the grafts will be purchased from a new supplier.

The nonclinical testing performed, including physical and biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent to the predicate devices.

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Image /page/10/Picture/0 description: The image shows the logo for "VASCUTEK TERUMO". The word "VASCUTEK" is in gray, with each letter outlined with a double line. To the left of the word is a circle that is split in half, with the left half being blue and the right half being red. The word "TERUMO" is in gray and is located below the word "VASCUTEK".

VASCUTEK Ltd Newmains Avenue, Inchinnan Renfrewshire PA4 9RR, Scotland, UK Tel: +44 (0) 141 812 5555 www.vascutek.com

510(k) Summary

This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.

Submitter:	Vascutek LtdNewmains AvenueInchinnanRenfrewshirePA4 9RRScotland, UK+44 (0) 141 812 555
Contact:	Neil McLachlanHead of Regulatory AffairsTel: +44 141 812 5555Email: N.McLachlan@vascutek.com
Date of Preparation:	29 June 2017
Trade Name:	Vascutek Gelweave™ Vascular Grafts
Common or Usual Name:	Vascular Prosthesis
Classification Name:	Vascular Graft Prosthesis
Review Panel:	Cardiovascular
Product Code:	DSY
Regulation Number:	21 CFR 870.3450
Device Class:	II

ldentification of the legally marketed device to which equivalence is being claimed Vascutek are claiming equivalence to the following legally marketed devices:

Gelweave™ Vascular Grafts (Bifurcated Configuration); K964665 ●

Gelweave Valsalva™ Vascular Grafts; K013022 .
Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque ● Markers; K060142
Gelweave™ Branched Vascular Grafts with Radiopaque Markers; K093817 ●

Device Description

Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.

The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.

K162794

{11}------------------------------------------------

The indications for use of the Gelweave vascular grafts are detailed below.

These are identical to the indications for use of the predicate devices.

Gelweave vascular grafts: "Indicated for thoracic reconstruction procedures for replacement of diseased segments of the thoracic aorta in cases of aneurysm, dissection, or coarctation."

Gelweave vascular grafts (Bifurcated Configuration); "Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease."

Gelweave Valsalva vascular grafts: "Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation."

Technological Characteristics

Equivalency is based on identical design, technology, construction and intended use.

The only change is that the gelatin used to seal the grafts will be purchased from a new supplier.

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.”