CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

K101866 · Cryolife, Inc. · DXZ · Jul 23, 2010 · Cardiovascular

Device Facts

• Record ID: K101866
• Device Name: CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
• Applicant: Cryolife, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

Device Story

CryoPatch SG is a human allograft patch derived from pulmonary valve and artery tissue; processed to remove cells and cellular debris; treated with antimicrobial solution; cryopreserved in tissue culture medium with cryoprotectants. Distributed in pulmonary hemi-artery, trunk, and branch configurations. Used in cardiac surgery for right ventricular outflow tract repair/reconstruction. Implantation reduces risk of HLA class I and II alloantibody induction compared to standard-processed tissues. Device stored at or below -135° C; supercooled via liquid nitrogen boost to minimize ice crystal damage. Surgeon implants patch during cardiac procedure; clinical benefit includes reduced immune response/alloantibody formation.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing including biomechanical properties, pulsatile flow characterization, accelerated wear testing, and histological analysis to support extended shelf life and tissue stability at cryogenic temperatures.

Technological Characteristics

Human pulmonary valve/artery allograft tissue; decellularized; antimicrobial treated; cryopreserved in tissue culture medium. Configurations: pulmonary hemi-artery, trunk, branch. Storage: -135° C. No electronic or software components.

Indications for Use

Indicated for repair or reconstruction of the right ventricular outflow tract in patients requiring cardiac surgical intervention.

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

• CryoPatch® SG Pulmonary Human Cardiac Patch (K091626)
• CryoValve® SG Pulmonary Human Heart Valve (and Conduit) (K033484, K083106, K092021)

Submission Summary (Full Text)

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K101866

**JUL 23 2010**

# CryoPatch SG Pulmonary Human Cardiac Patch Special 510(k) Submission

CryoLife, Inc.

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.

| Submitter: | CryoLife, Inc.<br>1655 Roberts Blvd., NW<br>Kennesaw, GA 30144<br>[phone] | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Ferros<br>Director, Regulatory Affairs | |
| Device Names: | Device Trade Name:<br>Common/Usual Name:<br>Classification Name: | CryoPatch® SG Pulmonary Human Cardiac Patch<br>Allograft Patch<br>Intracardiac patch or pledget |
| Intended Use: | CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction<br>of the right ventricular outflow tract. | |

#### Predicate Devices:

| Device | Company | 510 (k) Number(s),<br>Clearance Date | Product<br>Code |
|----------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------|-----------------|
| CryoPatch® SG<br>Pulmonary Human<br>Cardiac Patch | CryoLife, Inc.<br>Kennesaw, GA | K091626 - 08/07/2009 | DXZ |
| CryoValve® SG<br>Pulmonary Human Heart<br>Valve (and Conduit). | CryoLife, Inc.<br>Kennesaw, GA | K033484 - 02/07/2008<br>K083106 - 02/06/2009<br>K092021 - 05/25/2010 | OHA |

#### Device Description:

The Cryor atch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period, harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing cryoprotectants, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.

CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.

Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

### Scientific Evidence and Bench Testing Supporting Substantial Equivalence:

A scientific analysis and testing of long-term storage of tissue (product stability) as well as long-term package integrity testing were conducted to change the device shelf life. These tests included, biomechanical properties testing, pulsatile flow characterization and accelerated wear testing. The scientific analysis provided theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures,

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font. The seal is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 2 3 2010

CryoLife. Inc. c/o Mr. John D. Ferros Director, Regulatory Affairs 1655 Roberts Boulevard NW Kennesaw, GA 30144

Re: K101866

Trade/Device Name: CryoPatch® SG Pulmonary Human Cardiac Patch Regulation Number: 21 CFR 870.3470 Regulation name: Intracardiac Patch or Pledget Regulatory Class: Class II Product code: DXZ Dated: July 1, 2010 Received: July 2, 2010

Dear Mr. Ferros:

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, Jrug, 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, FTDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. John D. Ferros

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 vours.

Diana R. Vahner

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

Enclosure

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## Indications for Use

### 510(k) Number (if known): K101866

# Device Name: _CryoPatch® SG Pulmonary Human Cardiac Patch

Indications For Use: CryoPatch SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract

Prescription Use (Part 21 CFR 801 Subpart D) .

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunn R. Laine

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________