Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

Device Description

The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. The PTFE material has been impregnated with an absorbable mammalian gelatin that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Sulzer Vascutek SEALPTFE™ Vascular Prosthesis) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance against those criteria, or a detailed study design that would fit the requested format for AI/ML device studies. Instead, it describes in vitro and animal testing to show equivalence to existing devices.

Therefore, most of the requested information cannot be directly extracted or inferred from the provided text. I will address the points that can be, and explicitly state when the information is not available.

Description of the acceptance criteria and the study that proves the device meets the acceptance criteria:

The provided document describes the Sulzer Vascutek SEALPTFE™ Vascular Prosthesis and asserts its substantial equivalence to commercially distributed Impra grafts. The "acceptance criteria" in this context are not quantitative performance metrics as expected for AI/ML device studies, but rather demonstration of similar properties and safety to legally marketed predicate devices.

The study proving the device meets these "acceptance criteria" (i.e., substantial equivalence) involved:

In vitro testing: Comparing the Sulzer Vascutek SEALPTFE™ graft line to Impra commercial grafts.
Animal studies: Demonstrating the equivalence of Sulzer Vascutek standard wall grafts to Impra standard wall grafts.
Biomaterial testing: Confirming that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.

The document concludes that "all testing demonstrates that the Sulzer Vascutek SEALPTFE™ graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access."

1. A table of acceptance criteria and the reported device performance

As mentioned, quantitative acceptance criteria and performance metrics for an AI/ML device are not present in this document. The "performance" is substantial equivalence based on the types of tests listed above.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Implied)
Substantial equivalence to Impra commercial grafts	Demonstrated in vitro testing results.
Equivalence to Impra standard wall grafts	Demonstrated in animal studies for standard wall grafts.
Biocompatibility and non-toxicity	Demonstrated through biomaterial testing.
Mechanical properties (strength, suture retention, handling)	Substantially equivalent to products currently in commercial distribution (Impra).
Reduction of intraoperative suture hole bleeding	Intended function of the gelatin impregnation, which hydrolyzes within approx. 14 days.

The following information is not available in the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the in vitro or animal studies.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not present, as the "ground truth" here refers to physical and biological properties of the graft materials, evaluated through laboratory and animal testing, not expert interpretation of diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable; this method is typically used for expert consensus in diagnostic imaging or clinical trials, not for material property testing.

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

Not applicable. This is a medical device (vascular prosthesis), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context would be objective measurements of material properties (e.g., tensile strength, porosity, suture retention), results from standardized biocompatibility tests, and observations from animal implantation studies. Specific details are not provided beyond the general categories of "in vitro testing", "animal studies", and "biomaterial testing."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Sulzer Medica, a medical technology company. The text "SULZER MEDICA" is displayed in a bold, sans-serif font. Above the logo, there is a handwritten code "K993667".

JAN 2 8 2000

510(k) SUMMARY

SULZER VASCUTEK SEALPTFE™ VASCULAR PROSTHESIS

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)

The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is substantially equivalent to devices in commercial distribution by Impra, a division of C. R. Bard. All devices referenced under this application are 6mm in diameter or greater and are used to treat diseased or occluded systemic arteries and for A/V access. In addition, the application covers externally supported graft designs.

The device is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. Similar devices have been used clinically since the 1970's with few reported complications or material failures. PTFE typically is used as a synthetic conduit to replace natural vessels or as a shunt for AV/dialysis access. The mechanical properties of Sulzer Vascutek PTFE material such as strength, suture retention, and handling are substantially equivalent to products currently in commercial distribution.

The PTFE material has been impregnated with an absorbable mammalian gelain that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.

Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral bypass and femoralpopliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

In vitro testing conducted on the Sulzer Vascutek SEALPTHE™ graft line shows it to be substantially equivalent to Impra commercial grafts. Results from animal studies demonstrate that the Sulzer Vascutek standard wall grafts to be equivalent to Impra standard wall grafts. Results from biomaterial that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.

In summary, all testing demonstrates that the Sulzer Vascutek SEALPTFE™ graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access.

Common name of the Device:	Vascular Graft
Trade name of Proprietary Name:	Sulzer Vascutek SEALPTFE™ Vascular Prosthesis
Submitter and Contact Person:Edward E. NewtonRegulatory Affairs Manager1300 E. Anderson Lane, Austin, TX 78752Phone: (512) 435-3407 Fax: (512) 435-3350
Submission Submitted on:	October 29, 1999

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

JAN 2 8 2000

Mr. Edward E. Newton Regulatory Affairs Manager Sulzer Medica 1300 East Anderson Lane Austin, TX 78752

Re: K993667

Sulzer Vascutek SEALPTFE™ Vascular Prosthesis Requlatory Class: II Product Code: DSY Dated: October 29, 1999 Received: November 1, 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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Edward E. Newton

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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ta data de Emissão

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

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INDICATIONS FOR USE STATEMENT

510(K) Number (if known):	Unknown
Device Name:	Sulzer Vascutek SEALPTFE™ Vascular Prosthesis
Indications for Use:	Sulzer Vascutek SEALPTFE™ grafts are intended for thecreation of subcutaneous arteriovenous conduits for bloodaccess, bypass, or reconstruction of occluded or diseasedarterial blood vessels. Typical applications for standardwall grafts include systemic vascular repair, primarily foraxillo-femoral/bifemoral bypass and femoral-poplitealreconstruction. Typical applications for thin wall graftsinclude systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

510(K) Number (if known):

Unknown

Device Name:

Sulzer Vascutek SEALPTFE™ Vascular Prosthesis

Indications for Use:

Sulzer Vascutek SEALPTFE™ grafts are intended for thecreation of subcutaneous arteriovenous conduits for bloodaccess, bypass, or reconstruction of occluded or diseasedarterial blood vessels. Typical applications for standardwall grafts include systemic vascular repair, primarily foraxillo-femoral/bifemoral bypass and femoral-poplitealreconstruction. Typical applications for thin wall graftsinclude systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bess R. Lamphere
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ K 993667

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.”