Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access. Thin Wall Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).

Device Description

EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE). EXXCEL™ Soft ePTFE Vascular Grafts feature a GUIDELINE® stripe to facilitate proper graft alignment.

AI/ML Overview

The provided text describes a 510(k) summary for the MAQUET GETINGE GROUP's EXXCEL™ Soft ePTFE Vascular Grafts. As such, the study described is a non-clinical study focused on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI/ML device. Therefore, many of the requested categories related to AI/ML device evaluation (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.

Here's the information extracted and formatted according to your request, with a clear indication of non-applicability for categories that don't fit this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device)	Reported Device Performance
Kink Diameter	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Longitudinal Tensile Strength	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Wall Thickness	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Oblique Suture Retention Strength	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Longitudinal Suture Retention Strength	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Relaxed Internal Diameter	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Usable Length	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Water Entry Pressure (WEP)	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Radial Burst Strength (Burst Pressure)	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Strength After Repeated Puncture	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Pressurized Internal Diameter	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Biocompatibility Testing: Cytotoxicity	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.
Biocompatibility Testing: Hemolysis	Met specified acceptance criteria	Results met specified acceptance criteria and were substantially equivalent to predicate device.

Note: The acceptance criteria for each test are implicitly defined as achieving results that allow a determination of "substantial equivalence" to the predicate device, as explicitly stated in the document: "The results of these non-clinical tests met the specified acceptance criteria and were substantially equivalent to the predicate device."

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

Sample Size for Test Set: Not specified in the provided text, as this is a bench testing and biocompatibility study, not a clinical study involving a "test set" of patient data.
Data Provenance: Not applicable. The data comes from "bench testing and biocompatibility testing," which are laboratory-based studies.

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

Number of Experts: Not applicable. Ground truth for bench and biocompatibility testing is established through standardized laboratory methods and measurements, not expert review of a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No adjudication method is described for this type of non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study Done: No. This is a non-clinical study for a physical medical device (vascular graft), not an AI/ML diagnostic or prognostic tool.
Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

Ground Truth Type: For the bench tests (e.g., Kink Diameter, Tensile Strength, WEP, Burst Strength), the ground truth is based on measurements against established engineering specifications and performance characteristics of the predicate device. For biocompatibility, the ground truth is established through standardized biological assays (cytotoxicity, hemolysis) with predefined pass/fail criteria.

8. The Sample Size for the Training Set

Sample Size for 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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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

JAN 1 7 2012

MAQUET GETINGE GROUP

510(k) Summary (as required by 21 CFR 807.92)

510(k) Number:	K113101
Date Prepared:	November 28, 2011
Device Owner:	MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470
Contact Personnel:	Susan Eichler-Huston
Title:	Director, Regulatory Affairs
Email:	susan.eichler-huston@maquet.com
Phone:	973-709-7487Fax: 973-709-6522
Trade Name:	EXXCEL™ Soft ePTFE Vascular Grafts
Device Generic Name:	Vascular Graft Prosthesis
Classification:	According to Section 513 of the Federal Food, Drug andCosmetic Act, the device classification is Class II, PerformanceStandards.
Predicate Device:	EXXCEL™ Soft ePTFE Vascular Grafts
Device Description:	EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vasculargrafts constructed of expanded polytetrafluoroethylene(ePTFE). EXXCEL™ Soft ePTFE Vascular Grafts feature aGUIDELINE® stripe to facilitate proper graft alignment.
Indications for Use:	Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts aredesigned to repair or replace peripheral arteries (iliac, femoral,popliteal, infrageniculate vessels, axillary, renal) and to providevascular access. Thin Wall Exxcel™ Soft ePTFE VascularGrafts are designed to repair or replace peripheral arteries(iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).
TechnologicalCharacteristics	The proposed Exxcel Soft ePTFE Vascular Graft and thepredicate Exxcel Soft ePTFE Vascular Graft are similarwith respect to the following:
	Equivalent finished device characteristicsEquivalent indication for useEquivalent packaging, sterilization and shelf life
	The proposed Exxcel Soft ePTFE Vascular Graft and thepredicate Exxcel Soft ePTFE Vascular Graft, are different

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

with respect to the following:

The proposed device utilized a PTFE resin . manufactured using a non-PFOA surfactant as a process aid.
This difference is not considered a technological difference and is substantially equivalent to the predicate Exxcel Soft ePTFE Vascular Graft.

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The device was qualified through the following tests:

Kink Diameter .
Longitudinal Tensile Strength .
Wall Thickness .
Oblique Suture Retention Strength ●
Longitudinal Suture Retention Strength .
Relaxed Internal Diameter .
Usable Length .
Water Entry Pressure (WEP) .
Radial Burst Strength (Burst Pressure) .
Strength After Repeated Puncture .
Pressurized Internal Diameter .
Biocompatibility Testing .
- o Cytotoxicity
- o Hemolysis

The results of these non-clinical tests met the specified acceptance criteria and were substantially equivalent to the predicate device.

No new safety or performance issues were raised during the testing regimen.

Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the EXXCEL™ Soft ePTFE Vascular Graft has been shown to be substantially equivalent to the predicate device.

Safety and Performance:

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 7 2012

MAQUET Cardiovascular LLC c/o Ms. Susan Eichler-Huston Director, Regulatory Affairs 45 Barbour Pond Drive Wayne. NJ 07470

Re: K113101

Trade/Device Name: EXXCEL Soft ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: October 14, 2011 Received: October 19, 2011

Dear Ms. Eichler-Huston:

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. 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.

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

Page 2 – Ms. Susan Eichler-Huston

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K113101 510(k) Number (if known):

Device Name: EXXCEL™ Soft ePTFE Vascular Graft

Indications for Use:

Thin Wall Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign/Off)

Division of Cardiovascular Devices 510(k) Number

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Confidential

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.”