Gelsoft™ Plus Vascular Prostheses

K241070 · Vascutek, Ltd. · DSY · Nov 15, 2024 · Cardiovascular

Device Facts

• Record ID: K241070
• Device Name: Gelsoft™ Plus Vascular Prostheses
• Applicant: Vascutek, Ltd.
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Device Story

Gelsoft™ Plus Vascular Prostheses are gelatin-sealed knitted polyester grafts used for vascular repair. The device functions as a mechanical conduit for blood flow in the abdomen, replacing or bypassing diseased or aneurysmal arteries. It is intended for use by vascular surgeons in a clinical or surgical setting. The device is implanted to restore arterial patency and structural integrity. The current submission reflects changes in the gelatin supplier, yarn supplier, and sterilization suite compared to the predicate device.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was demonstrated through non-clinical testing, including bench testing, shelf-life validation, packaging validation, biocompatibility testing, chemical characterization, and an animal performance study.

Technological Characteristics

Knitted polyester (PET) textile graft sealed with bovine gelatin. The device maintains the same material composition and principle of operation as the predicate. Technical changes involve the supply chain for raw materials (gelatin and yarn) and the sterilization process.

Indications for Use

Indicated for vascular repair, replacement, or bypass of damaged and diseased abdominal arteries in patients with aneurysmal or occlusive disease.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Vascutek Gelsoft™ Plus Vascular Grafts (K162803)

Submission Summary (Full Text)

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November 15, 2024

Vascutek Ltd. Ryan King Regulatory Affairs Associate II Newmains Avenue Inchinnan Renfrewshire, PA49RR United Kingdom

Re: K241070

Trade/Device Name: Gelsoft™ Plus Vascular Prostheses Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: April 19, 2024 Received: April 19, 2024

Dear Ryan King:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

# Rohini Retarekar -S

Carmen Gacchina Johnson, Ph.D. 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

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# Indications for Use

510(k) Number (if known) K241070

Device Name Gelsoft™ Plus Vascular Prostheses

Indications for Use (Describe)

Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

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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### 510(k) Summary - K241070

#### November 08, 2024

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

## CONTACT DETAILS

| Applicant Name: | Vascutek Ltd. |
|------------------------------|--------------------------------------------------------------|
| Applicant Address: | Newmains Avenue Inchinnan Renfrewshire PA49RR United Kingdom |
| Applicant Contact Telephone: | [phone] |
| Applicant Contact: | Mr. Ryan King |
| Applicant Contact Email: | [e-mail] |
| Date of Submission: | April 19, 2024 |

### DEVICE NAME

| Device Trade Name: | Gelsoft™ Plus Vascular Prostheses |
|----------------------|---------------------------------------------------------|
| Common Name: | Vascular graft prosthesis |
| Classification Name: | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Regulation Number: | 870.3450 |
| Product Code(s): | DSY |

#### LEGALLY MARKETED PREDICATE DEVICES

Predicate #: K162803 Predicate Trade Name: Vascutek Gelsoft™ Plus Vascular Grafts Product Code: DSY

#### DEVICE DESCRIPTION SUMMARY

Gelsoft™ Plus vascular prostheses are gelatin sealed knitted polyester prosther repair. The Gelsoft™ Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

### INTENDED USE/INDICATIONS FOR USE

Gelsoft" Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

### INDICATIONS FOR USE COMPARISON

The intended use and indications for use of the device are identical to the predicate.

### TECHNOLOGICAL COMPARISON

The subject and predicate device have similar design and identical intences in technological characteristics include change in supplier of the gelatin used to seal the graft, change in yarn supplier and implementation of a new sterlization suite. Both this and the predicate device are based on knitted polyester textile technology. They use the same materials (PET yarn and bovine gelatin) and have the same principles of operation.

The nonolinical testing performed, including benilization, packaging, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have demonstrated that the predicate device.

#### NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS

Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency.

No clinical testing was necessary to demonstrate substantial equivalence.