The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Device Description

AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AlboSure™ Polyester Vascular Patch, which is a cardiovascular patch. The document focuses on demonstrating substantial equivalence to a predicate device, rather than elaborating on a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy—which would be typical for AI/ML-driven medical devices.

Therefore, the following information is not applicable or extractable from the provided text for this medical device, as it is a physical patch and not a software/AI device:

Acceptance criteria and reported device performance (in the context of AI/ML metrics): The document lists "Summary of Product Testing" with tests like Tensile Strength, Burst Strength, Wall Thickness, Suture Retention Strength, and Water Permeability. However, it does not provide specific acceptance criteria (i.e., numerical thresholds) or reported performance values for these tests. The conclusion only states "LeMaitre Vascular has demonstrated that the AlboSure Polyester Vascular Patch is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology," implying these physical tests were satisfactory for equivalence.
Sample size used for the test set and the data provenance: Not applicable as there isn't a "test set" in the context of an AI/ML study. The product testing mentioned would involve material samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for a physical device would be its objective physical and biological properties.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory approval through substantial equivalence, which is a comparison to a legally marketed predicate device rather than an independent performance study against defined acceptance criteria (as would be typical for AI/ML submissions).

In summary, based on the provided text, the questions about acceptance criteria and study details (especially those pertaining to AI/ML device evaluation) cannot be answered because the device is a physical cardiovascular patch, and the submission is for substantial equivalence, not an AI/ML algorithm performance study.

Summary

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K101740

SECTION 5: 510(K) Summary

Submitter:	LeMaitre Vascular, Inc.63 Second AvenueBurlington, MA 01803SEP 20 2010
Contact Person:	Vic ZhangRegulatory Affairs SpecialistPhone: 781-221-2266 x162Fax: 781-425-5049Email: xzhang@lemaitre.com
Date Prepared:	June 18, 2010
Trade Name:	AlboSure™ Cardiovascular Patch
Common Name:	Cardiovascular Patch
Classification Name:	Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
Predicate Device:	Hemashield Finesse Knitted Cardiovascular Patch (K962342)
Device Description:	AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent.
Intended Use:	The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting.
Summary of Technological Characteristics:	AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent.
Summary of Product Testing:	Following tests have been performed:Tensile Strength, Burst Strength, Wall Thickness, Suture Retention Strength, Water Permeability.
Summary of Pre-clinical Study:	The biocompatibility of the device was tested per ISO10993-1.
Conclusion:	LeMaitre Vascular has demonstrated that the AlboSure Polyester Vascular Patch is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

LeMaitre Vascular, Inc. c/o Mr. Vic Zhang Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

SEP 2 0 2010

Re: K101740

Trade/Device Name: AlboSure™ Polyester Vascular Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II Product Code: DXZ Dated: June 18, 2010 Received: June 21, 2010

Dear Mr. Zhang:

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 I varial 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 If your device 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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Page 2 - Mr. Vic Zhang

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.

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,

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

Enclosure

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SECTION 4: INDICATION FOR USE STATEMENT

510(k) Number (if known): _

101740

Device Name: AlboSure™ Polyester Vascular Patch

SEP 2 0 2010

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Siam Off) Division of Cardiovasculo 510(k) Number

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).