(202 days)
Not Found
No
The description focuses on the material composition and manufacturing process of a vascular graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a vascular graft used for surgical repair and reconstruction of blood vessels, which directly addresses a medical condition or aims to restore a physiological function.
No
Explanation: The device is a surgical graft used for vascular repair, not for identifying or investigating a disease or condition. Its purpose is therapeutic, not diagnostic.
No
The device description clearly details a physical, implantable vascular graft made of polyester and gelatin, with an external polypropylene support. This is a hardware 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 for "extra anatomical vascular repair," specifically for surgical procedures like bypass and reconstruction. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "knitted polyester graft" with an external support and gelatin sealant. This is a physical device designed to be implanted in the body to replace or bypass blood vessels.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical implant used to repair or replace blood vessels within the body.
N/A
Intended Use / Indications for Use
Indicated for extra anatomical vascular repair, primarily for axillo-femoral bypass and femoro- popliteal reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
DSY
Device Description
Gelsoft Plus ERS grafts are an externally reinforced (ERS), gelatin-sealed, knitted polyester grafts.
Vascutek's polyester vascular prosthesis family is based on a polyester textile technology. The starting point for all products is polyester yarn. This is fabricated into tubular form by knitting. This is referred to as the base fabric and exists in a variety of designs to meet particular end uses. Further processing is designed to retain the tubular form of the graft e.g. crimping and addition of an external polypropylene support. In Gelsoft Plus ERS, this external polypropylene support is to provide kink resistance and a smooth flow surface for extra-anatomical applications. The polypropylene support may be peeled where it extends to the ends of the prosthesis, in order to facilitate the fashioning of the anastomosis. Additional branches are also attached in a variety of configurations. The last process is impregnation with a bovine derived gelatin sealant. This process fills the gaps between threads of the polyester base graft and eliminates the need for pre-clotting of the graft prior to implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extra anatomical vascular repair
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 bench, biocompatibility, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent 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.”
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April 6, 2021
Vascutek Ltd Chirag Merchant Senior Regulatory Affairs Associate Newmains Avenue, Inchinnan Renfrewshire PA4 9RR Scotland. UK
Re: K202703
Trade/Device Name: Gelsoft Plus ERS Vascular Grafts Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY Dated: February 12, 2021 Received: February 25, 2021
Dear Chirag Merchant:
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 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
1
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 (QS) 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.
Rohini Retarekar -S
for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202703
Device Name Vascutek Gelsoft Plus ERS Vascular Graft
Indications for Use (Describe)
Indicated for extra anatomical vascular repair, primarily for axillo-femoral bypass and femoro- popliteal reconstruction.
| 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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Image /page/3/Picture/1 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. The logo is simple and modern.
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) 141 812 555 |
| Contact: | Chirag Merchant
Senior Regulatory Affairs Associate
Tel: +44 (0) 141 812 555
Email: c.merchant@terumoaortic.com |
| Date of Preparation: | April 2, 2021 |
| Trade Name: | Vascutek Gelsoft Plus ERS Vascular Graft |
| Common or Usual Name: | Vascular Graft Prosthesis |
| Classification Name: | Prosthesis, vascular graft, of 6mm and
greater diameter |
| Product Code: | DSY |
| Regulation Number: | 21 CFR 870. 3450 |
| Device Class: | II |
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Image /page/4/Picture/0 description: The image contains the logo for Terumo Aortic. The word "TERUMO" is in large, green, sans-serif font with a red swoosh above the letters "TE". Below the word "TERUMO" is the word "Aortic" in a smaller, gray, sans-serif font. The logo is simple and modern.
Identification of the legally marketed device to which equivalence is being claimed:
Vascutek Ltd. are claiming equivalence to the following legally marketed devices:
- . Vascutek Gelsoft Plus ERS (K034010).
Device Description:
Gelsoft Plus ERS grafts are an externally reinforced (ERS), gelatin-sealed, knitted polyester grafts.
Vascutek's polyester vascular prosthesis family is based on a polyester textile technology. The starting point for all products is polyester yarn. This is fabricated into tubular form by knitting. This is referred to as the base fabric and exists in a variety of designs to meet particular end uses. Further processing is designed to retain the tubular form of the graft e.g. crimping and addition of an external polypropylene support. In Gelsoft Plus ERS, this external polypropylene support is to provide kink resistance and a smooth flow surface for extra-anatomical applications. The polypropylene support may be peeled where it extends to the ends of the prosthesis, in order to facilitate the fashioning of the anastomosis. Additional branches are also attached in a variety of configurations. The last process is impregnation with a bovine derived gelatin sealant. This process fills the gaps between threads of the polyester base graft and eliminates the need for pre-clotting of the graft prior to implant.
Intended Use:
The intended use of the Gelsoft Plus ERS vascular graft is for the extra-anatomical vascular repair.
Indications for Use:
Vascutek Gelsoft Plus ERS Graft is indicated for extra anatomical vascular repair, primarily for axillo-femoral/bi-femoral bypass and femoro- popliteal reconstruction.
Gelsoft Plus ERS AX -FEM Vascular Graft: Indicated for vascular repair i.e. primarily for axillo-femoral bypass procedures & femoral- popliteal reconstruction in aneurysmal & occlusive disease of the arteries.
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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 that, the word "Aortic" is in gray. The logo is simple and clean, and the colors are eye-catching.
Gelsoft Plus ERS FEM Vascular Graft: Indicated for vascular repair i.e. primarily for femoro-femoral bypass procedures in aneurysmal & occlusive disease of the arteries.
Gelsoft Plus ERS AX- BIFEM Vascular Graft: Indicated for vascular repair i.e. primarily for axillo-bi-femoral bypass procedures in aneurysmal & occlusive disease of the arteries.
Intended Patient Population:
Patients requiring extra anatomical vascular repair whenever knitted polyester grafts are normally indicated, primarily for axillo-femoral/bi-femoral bypass and femoro-popliteal reconstruction in aneurysmal & occlusive disease of the arteries.
They are contraindicated for use in patients with a sensitivity to polyester or materials of bovine origin. They are contraindicated for coronary vascular repair, blood access fistula (e.g. haemodialysis) and pulmonary shunting. They are contraindicated for thoracic use. They are contraindicated for use in the pulmonary positions, use in arteriovenous shunting or cardiovascular patching.
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 bench, biocompatibility, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent to the predicate device.
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