ALBOSURE POLYESTER VASCULAR PATCH

K101740 · LeMaitre Vascular, Inc. · DXZ · Sep 20, 2010 · Cardiovascular

Device Facts

• Record ID: K101740
• Device Name: ALBOSURE POLYESTER VASCULAR PATCH
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Sep 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

AlboSure Polyester Vascular Patch is a knitted polyester fabric; impregnated with bovine collagen; contains glycerol as softening agent. Used for cardiac and vascular patch grafting; indicated for patients requiring systemic heparinization. Device provides structural support during surgical repair. Clinical benefit derived from biocompatible material facilitating tissue repair in cardiovascular procedures.

Clinical Evidence

Bench testing only. Testing included tensile strength, burst strength, wall thickness, suture retention strength, and water permeability. Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Knitted polyester fabric; impregnated with bovine collagen; contains glycerol as softening agent. Biocompatibility tested per ISO 10993-1. Class II device (21 CFR 870.3470).

Indications for Use

Indicated for cardiac and vascular patch grafting in patients requiring systemic heparinization prior to or during surgery.

Regulatory Classification

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.

Predicate Devices

• Hemashield Finesse Knitted Cardiovascular Patch (K962342)

Submission Summary (Full Text)

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# K101740

### SECTION 5: 510(K) Summary

| Submitter: | LeMaitre Vascular, Inc.<br>63 Second Avenue<br>Burlington, MA 01803<br>SEP 20 2010 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vic Zhang<br>Regulatory Affairs Specialist<br>Phone: [phone] x162<br>Fax: [phone]<br>Email: [e-mail] |
| 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:<br>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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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 [phone] or [phone] 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:

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.

Prescription Use______________________________________________________________________________________________________________________________________________________________

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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