Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.

Device Description

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft with a base graft porosity of 2118 ml/cm³/min. The knitted polyester material has been impregnated with an absorbable mammalian gelatin that seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.

AI/ML Overview

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft. It is indicated for abdominal and peripheral vascular repair, specifically for replacement or bypass in aneurysmal and occlusive disease of arteries.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Metric	Acceptance Criteria	Reported Device Performance	Comments
In Vitro Performance	Burst Strength	Not explicitly stated, implied to be comparable to predicates	Acceptable structural characteristics, comparable to predicate devices (Meadox Hemashield Vantage, Meadox Hemashield Microvel Double Velour Knitted, Impra ePTFE)	Side-by-side in vitro testing performed.
	Suture Retention	Not explicitly stated, implied to be comparable to predicates	Acceptable structural characteristics, comparable to predicate devices	Side-by-side in vitro testing performed.
	Tensile Strength	Not explicitly stated, implied to be comparable to predicates	Acceptable structural characteristics, comparable to predicate devices	Side-by-side in vitro testing performed.
	Nominal Wall Thickness	Not explicitly stated, implied to be comparable to predicates	Acceptable structural characteristics, comparable to predicate devices	Side-by-side in vitro testing performed.
Clinical Performance	Graft Patency	Non-inferiority to predicate (Impra ePTFE)	No difference in graft patency between Gelsoft™ and Impra ePTFE grafts	Clinical trial performed.
Biocompatibility	General Biocompatibility	Established for intended use	Thoroughly tested and characterized; materials have extensive history of use in medical applications.	Gelatin sealant previously approved (PMA P890045, P890045/SI).
Sterilization	Sterilization Method	Ethylene Oxide compatibility	Device supplied with Ethylene Oxide sterilization.	Standard method.
Shelf-Life	Device Shelf-Life	5 years	A shelf-life of 5 years has been established.	Clear numerical criterion and performance.
Preclotting Requirement	Need for Preclotting	Not required	Does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.	Key design feature and performance claim.

2. Sample Size Used for the Test Set and the Data Provenance:

In Vitro Testing: The text does not specify the sample size for the in vitro tests (burst strength, suture retention, tensile strength, nominal wall thickness).
Clinical Trial: The text mentions a "prospective randomized clinical trial" but does not specify the sample size (number of patients or grafts) used for this trial.
Data Provenance:
- In Vitro Testing: Performed using the Sulzer Vascutek Gelsoft™ graft and predicate devices. No specific geographic origin of the data is mentioned, but typically such testing would occur at the manufacturer's facility or an accredited lab.
- Clinical Trial: Described as a "prospective randomized clinical trial." The country of origin for the clinical trial is not explicitly stated. Given the submission to the FDA, it's plausible it involved US sites or was a multi-center international trial where data was compiled for US submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

For the Clinical Trial: The text states, "The investigators concluded that there was no difference in graft patency between the two grafts." "Investigators" typically refers to medical professionals (e.g., surgeons, vascular specialists) involved in the trial. However, the exact number of experts, their specific qualifications (e.g., years of experience, subspecialty), and how they established the "ground truth" (e.g., patency assessment method) are not specified in this document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

The document does not specify any adjudication method for either the in vitro testing or the clinical trial. For clinical trials, blinding, independent core labs, or expert committees are often used for outcome adjudication, but this information is not present.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human interpretation of images or data is involved. This document describes a vascular prosthesis, which is a physical medical device, not a diagnostic AI tool.

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

No, a standalone algorithm performance study was not done. As mentioned above, this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For In Vitro Testing: The "ground truth" for these engineering properties (burst strength, suture retention, tensile strength, nominal wall thickness) would be the objective measurements obtained through standardized laboratory testing methods, likely guided by international or national standards for medical devices or vascular grafts.
For the Clinical Trial: The "ground truth" for graft patency (the primary outcome) would be based on outcomes data from the patients in the trial, likely assessed through objective diagnostic methods such as ultrasound, angiography, or clinical examination over time. The "investigators" would have collectively determined this outcome.

8. The Sample Size for the Training Set:

This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The term "training set" is not applicable here. The device's design and manufacturing are based on established engineering principles and prior material knowledge, not a data-driven training process.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set," this question is not applicable.

Summary

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DEC - 9 1999

SULZER MEDICA

K990503

Sulzer Carbomedics Inc.

1300 East Anderson Lane Austin, Texas 78752-1793

Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada)

510(k) SUMMARY SULZER VASCUTEK GELSOFT™ VASCULAR PROSTHESIS

Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. The polyester material and gelatin sealant have been thoroughly tested and characterized with regard to biocompaibility for their intended use. The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is supplied sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established.

Side-by-side in vitro testing which evaluated burst strength, suture retention, tensile strength, and nominal wall thickness was performed using the Sulzer Vascutek Gelsoft™ graft and predicate devices that include the Meadox Hemashield Vantage Graft, Meadox Hemashield Microvel Double Velour Knitted Graft, and Impra ePTFE Graft, This testing demonstrated the acceptable structural and performance characteristics of the Gelsoft™ graft for peripheral vascular repair.

A prospective randomized clinical trial was performed to compare graft patency between the Gelsoft™ and Impra ePTFE grafts for femoropopliteal bypass. The investigators concluded that there was no difference in graft patency between the two grafts.

Sulzer Carbomedics considers the Sulzer Vascutek Gelsoft™ Vascular Prosthesis to be substantially equivalent to the currently marketed predicate devices for peripheral vascular repair.

Common name of the Device:	Vascular Graft
Trade name of Proprietary Name:	Sulzer Vascutek Gelsoft™ Vascular Prosthesis
Submitter and Contact Person:	Edward E. NewtonSr. Regulatory Affairs Specialist1300 E. Anderson Lane, Austin, TX 78752Phone: (512) 435-3407Fax: (512) 435-3350
Submission Submitted on:	February 16, 1999

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Mr. Edward E. Newton Regulatory Affairs Manager Sulzer Carbomedics Inc. 1300 East Anderson Lane Austin, Texas 78752

K990503 /S2 Re: Sulzer Vasutek Gelsoft Vascular Prosthesis Regulatory Class: II Product Code: DSY Dated: November 4, 1999 Received: November 5, 1999

Dear Mr. Newton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edward E. Newton

This letter will allow you to begin marketing your device as rnio recei will as a more to notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M Acting Director Division of Cardiovascular Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Device and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(K) Number (if known):	Unknown
Device Name:	Sulzer Vascutek Gelsoft™ Vascular Prosthesis
Indications for Use:	Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicatedfor abdominal and peripheral vascular repair, i.e.replacement or bypass in aneurysmal and occlusivedisease of arteries.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

lege Kemper a

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K990563

Prescription Use

Over-the-Counter Use

(Optional Format 1-2-96)

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.”