K Number
K200955
Device Name
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Manufacturer
Date Cleared
2020-07-08

(90 days)

Product Code
Regulation Number
870.3470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated. Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.
Device Description
The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation. Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses. The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.
More Information

Not Found

No
The summary describes a passive, physical medical device (vascular patch fabric) and contains no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes.
The device is indicated for vascular repair, which is a therapeutic intervention.

No

The device description clearly states its purpose is for "vascular repair" using "knitted, polyester patch fabrics." It is an implantable medical device used in surgery, not a diagnostic tool.

No

The device description clearly states it is a range of gelatin sealed, knitted, polyester patch fabrics, which are physical, implantable medical devices. There is no mention of software as the primary component or function.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "vascular repair whenever knitted polyester fabrics are normally indicated." This describes a surgical implant used in vivo (within the body) to repair blood vessels.
  • Device Description: The description details a "range of gelatin sealed, knitted, polyester patch fabrics" designed for surgical implantation.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an implantable surgical device.

N/A

Intended Use / Indications for Use

Vascutek Cardiovascular Fabric is indicated for vascular or cardiovascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for patch closure after endarterectomy, particularly of the carotid arteries.

Product codes (comma separated list FDA assigned to the subject device)

DXZ

Device Description

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.

Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.

The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vascular or cardiovascular vessels, in particular thoracic, peripheral, carotid arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 nonclinical testing performed, including physical, biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

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.

K963611

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

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 8, 2020

Vascutek Ltd Heidi Forsyth Regulatory Affairs Associate Newmains Avenue Inchinnan, Renfrewshire PA4 9RR United Kingdom

Re: K200955

Trade/Device Name: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: April 6, 2020 Received: April 9, 2020

Dear Heidi Forsyth:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200955

Device Name

Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

Indications for Use (Describe)

Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.

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

"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."

3

Image /page/3/Picture/0 description: The image shows the Terumo Aortic logo. The word "TERUMO" is in green, and the word "Aortic" is in gray. There is a red shape above the word "TERUMO". The logo is simple and clean.

K200955

Vascutek Ltd Newmains Avenue, Inchinnan Renfrewshire PA4 9RR Scotland, UK

Tel. +44 (0) 141 812 5555 terumoaortic.com

510 (k) Summary

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

| Submitter: | Vascutek Ltd
Newmains Avenue
Inchinnan
Renfrewshire
PA4 9RR
Scotland, UK
Tel: +44 (0) 141 812 5555 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Heidi Forsyth
Regulatory Affairs Associate
Tel: +44 (0) 141 812 5555
Email: h.forsyth@terumoaortic.com |
| Date of Preparation: | 03 April 2020 |
| Trade Name: | Vascutek Gelseal™ Cardiovascular Fabric
Patches
Vascutek Gelsoft™ Cardiovascular Fabric
Patches
Vascutek Thin Wall Carotid Patch |
| Common or Usual Name: | Cardiovascular Patch |
| Product Code: | DXZ |
| Regulation Number: | 21 CFR 870: 3470 |
| Device Class: | II |

Image /page/3/Picture/7 description: The image is a logo for The Queen's Awards for Enterprise: Innovation 2016. The logo features a stylized letter "e" with a wing-like design extending from the left side. Above the "e" is a crown, symbolizing the Queen's authority and endorsement of the awards.

4

Image /page/4/Picture/0 description: The image shows the Terumo Aortic logo. The word "TERUMO" is in green with a red swoosh above it. Below that, the word "Aortic" is in gray.

Identification of the legally marketed device to which equivalence is being

claimed: Vascutek Ltd. are claiming equivalence to the following legally marketed devices:

Vascutek Cardiovascular Fabric:

  • Vascutek Gelseal™ Patch (K963611) ●
  • Vascutek Gelsoft™ Patch (K963611) .
  • Vascutek Thin Wall Carotid Patch (K963611) ●

Device Description

The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.

Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.

The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.

Intended Use

The intended use of the Vascutek Cardiovascular Fabric is for vascular patch grafting and for intracardiac patching.

Image /page/4/Picture/13 description: The image is a logo for The Queen's Awards for Enterprise: Innovation 2016. The logo features a stylized letter "e" with a wing-like design on the left side. Above the "e" is a crown, symbolizing the Queen's authority and endorsement. The text "THE QUEEN'S AWARDS FOR ENTERPRISE: INNOVATION 2016" is placed below the "e".

5

Image /page/5/Picture/0 description: The image shows the Terumo Aortic logo. The word "TERUMO" is in green, with a red swoosh above it. Below the word "TERUMO" is the word "Aortic" in gray. The logo is simple and clean, and the colors are eye-catching.

The Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

Indications for Use

Vascutek Cardiovascular Fabric is indicated for vascular or cardiovascular repair whenever knitted polyester fabrics are normally indicated.

Due to its particularly high strength Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for patch closure after endarterectomy, particularly of the carotid arteries.

Intended Patient Population

Gelseal and Gelsoft Patches: Patients requiring repair of vascular or cardiovascular vessels, in particular thoracic repair for Gelseal Patches and peripheral repair in the case of Gelsoft. They are contraindicated for use in patients with a sensitivity to polyester or materials of bovine origin.

Thin Wall Carotid Patches: Patients requiring repair of vascular or cardiovascular vessels, in particular patch closure after endarterectomy of the carotid arteries. They are contraindicated for use in patients with a sensitivity to polyester or materials of bovine origin.

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, biocompatibility testing, chemical characterisation and an animal performance study, have demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

Image /page/5/Picture/12 description: The image shows the logo for The Queen's Awards for Enterprise: Innovation 2016. The logo features a stylized letter "e" with a wing-like design extending from the left side. Above the "e" is a crown, symbolizing the British monarchy. The text "THE QUEEN'S AWARDS FOR ENTERPRISE: INNOVATION 2016" is placed below the "e".