Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

Device Description

AI/ML Overview

The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric, including the Gelseal™ patch, Gelsoft™ patch, and Thin Wall Carotid patch, underwent comprehensive in vitro and in vivo testing to demonstrate its substantial equivalence to the predicate device, Sulzer Vascutek Cardiovascular Fabric (K963611).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement that the testing "provides evidence that Sulzer Vascutek Fluoropassiv™ Fabric is substantially equivalent to the predicate fabric." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device's performance across several key metrics was deemed acceptable compared to the predicate.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Burst Strength	Substantially equivalent to predicate fabric (K963611)	Acceptable in vitro performance
Suture Retention	Substantially equivalent to predicate fabric (K963611)	Acceptable in vitro performance
Tensile Strength	Substantially equivalent to predicate fabric (K963611)	Acceptable in vitro performance
Water Porosity	Substantially equivalent to predicate fabric (K963611)	Base fabric porosity of 1433 ml/cm²/min and 3495 ml/cm²/min
In Vivo Performance	Acceptable in vivo performance based on animal testing	Acceptable in vivo performance demonstrated in animal testing
Biocompatibility	Suitable for intended use	Thoroughly tested and characterized
Shelf-Life	Established shelf-life	4 years

Study Details:

Sample sizes used for the test set and the data provenance:
- The document does not specify the precise sample sizes used for each in vitro test (burst strength, suture retention, tensile strength, water porosity) or for the animal testing.
- Data Provenance: The nature of the studies (in vitro performance testing and animal testing) suggests these were prospective studies conducted specifically for this 510(k) submission. No information is provided regarding the country of origin for the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study primarily relies on objective physical property measurements and animal model observations rather than expert consensus on subjective assessments.
Adjudication method for the test set:
- This information is not provided. Given the nature of the tests (physical properties and animal studies), and the lack of human interpretation, a formal adjudication method as typically used for image-based or clinical diagnostic studies is unlikely to have been applied in this context.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is not relevant for evaluating the performance of a cardiovascular fabric, which is an implantable medical device assessed through physical and biological property testing rather than human interpretation of data.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The in vitro performance testing and animal testing are standalone assessments of the device's physical and biological properties, independent of human clinical application interpretation. There is no algorithm involved.
The type of ground truth used:
- In vitro testing: The ground truth for performance metrics like burst strength, suture retention, tensile strength, and water porosity is based on direct physical measurements and established engineering standards, compared against the properties of the predicate device.
- Animal testing: The ground truth for in vivo performance and biocompatibility is established through direct observation and analysis of biological responses in animal models.
- Biocompatibility: The ground truth for biocompatibility is established through well-characterized materials and testing according to relevant standards to ensure suitability for intended use.
- Gelatin sealant: The safety and effectiveness of the gelatin sealant were previously established and approved through PMA# P890045 for the Sulzer Vascular Gelseal™ Vascular Graft.
The sample size for the training set:
- This concept is not applicable here as this is not a machine learning or AI-based device. The device's performance is established through direct physical and biological testing, not through training on a dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of medical device evaluation.

Summary

{0}------------------------------------------------

SULZER MEDICA

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 FLUOROPASSIV™ CARDIOVASCULAR FABRIC

The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each product line is fluoropolymer coated and gelatinsealed, knitted polyester, with a base fabric porosity of 1433 ml/cm²/min, and 3495 ml/cm²/min, respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses 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 United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a family of cardiovascular patches that do not require precloting even when patients have been anticoagulated or when bleeding is a prime concern. The gelatin has been shown to be safe and effective through the approval of the Sulzer Vascular Gelseal™ Vascular Graft, PMA# P890045 on January 11, 1993.

Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric is indicated for vascular patch grafting and for intracardiac The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after patching. endarterectorny, particularly of the carotid arteries. Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric is manufactured from materials that have an extensive history of use in cardiovascular and other medical This polyester material, fluoropolymer, and gelatin sealant have been thoroughly tested and applications. characterized with regard to biocompatibility and suitability for their intended use. Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric is supplied sterilization used is Ethylene Oxide. A shelf-life of 4 years has been established.

Comprehensive in vitro performance testing has been performed on Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric. In vitro performance testing performed for the Sulzer Vascutek Fluoropassiv™ Fabric and Sulzer Vascutek Cardiovascular Fabric, which included burst strength, suture retention, tensile strength and water porosity, provides evidence that Sulzer Vascutek Fluoropassiv™ Fabric is substantially equivalent to the predicate fabric. In addition, animal testing demonstrates acceptable in vivo performance for the Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric.

Sulzer Carbomedics considers Vascutek Fluoropassiv™ Cardiovascular Fabric safe, effective and substantially equivalent in intended use and function to the Sulzer Vascutek Cardiovascular Fabric which received marketing clearance on November 21, 1996, under 510(k) K963611.

Common name of the Device:	Cardiovascular Patch
Trade name of Proprietary Name:	Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric:
	Sulzer Vascutek Fluoropassiv™ Gelseal™ Patch
	Sulzer Vascutek Fluoropassiv™ Gelsoft™ Patch
	Sulzer Vascutek Fluoropassiv™ Thin Wall Carotid Patch
Submitter and Contact Person:	Edward E. Newton, Sr. Regulatory Affairs Specialist1300 E. Anderson Lane, Austin, TX 78752
	Phone: (512) 435-3407 Fax: (512) 435-3350
Submission Submitted on:	June 10, 1997

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted with a staff entwined by two snakes and topped with wings.

APR 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Edward E. Newton Sr. Regulatory Affairs Specialist Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793

K972201 Re: Sulzer Vascutek Fluoropassiv™ Cardovascular Fabric Regulatory Class: II (Two) Product Code: 74 DXZ Dated: April 1, 1998 Received: April 2, 1998

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 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 Register. 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.

{2}------------------------------------------------

Page 2 - Mr. Edward E. Newton

This letter will allow you to begin marketing your device as described in your 510(k) premarket 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" (21 CFR 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/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K972201

Device Name:_ Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric

Indications For Use: Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tere R. Linyera

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use X (Per 21 CFR 801.109)

. OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).