CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)

K092021 · Cryolife, Inc. · OHA · May 25, 2010 · CV

Device Facts

• Record ID: K092021
• Device Name: CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
• Applicant: Cryolife, Inc.
• Product Code: OHA · CV
• Decision Date: May 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

CryoValve® SG Pulmonary Human Heart Valve (and Conduit) are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

Device Story

CryoValve SG is human heart valve allograft recovered from qualified donors; processed via antimicrobial treatment and decellularization to remove cells/debris; cryopreserved in tissue culture medium with cryoprotectant. Packaged in three-pouch system for aseptic OR introduction; stored in liquid nitrogen (-135°C to -196°C). Implantation reduces HLA class I and II alloantibody induction compared to standard-processed valves. Used by surgeons in cardiac procedures to replace pulmonary valves or repair valvular lesions. Clinical benefit includes reduced immune response; long-term durability/rejection resistance effects not evaluated.

Clinical Evidence

Bench testing only. Evidence includes biomechanical properties testing, pulsatile flow characterization, and accelerated wear testing to support shelf-life extension. Histological evidence provided for tissue stability at cryogenic temperatures.

Technological Characteristics

Human heart valve allograft; decellularized; cryopreserved in tissue culture medium with cryoprotectant. Three-pouch packaging system for aseptic handling. Storage: liquid nitrogen (-135°C to -196°C).

Indications for Use

Indicated for patients requiring replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, including those undergoing the Ross Procedure. Used to repair congenital and acquired valvular lesions.

Regulatory Classification

Identification

For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.

Predicate Devices

• CryoValve® SG Pulmonary Human Heart Valve (and Conduit) (K033484)
• CryoValve® SG Pulmonary Human Heart Valve (and Conduit) (K083106)

Submission Summary (Full Text)

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# 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] | MAY 2 5 2010 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | John D. Ferros<br>Director, Regulatory Affairs | |
| Device Names: | Device Trade Name:<br>Common/Usual Name:<br>Classification Name: | CryoValve® SG Pulmonary Human Heart Valve (and Conduit)<br>Human Heart Valve<br>Unclassified |
| Intended Use: | CryoValve® SG Pulmonary Human Heart Valve (and Conduit) are indicated for the<br>replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic<br>pulmonary valves. They may also be used in the replacement of native pulmonary valves<br>when the Ross Procedure is performed. Pulmonary heart valve allografts are used to<br>repair both congenital and acquired valvular lesions. | |

#### Predicate Devices:

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

### Device Description:

The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial solution, and treated to remove the cells and cellular debris that has not already been removed during the postmonten, and harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium, cretaining a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system nonly withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room, Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.

Implantation of the CryoValve SG Pulmonary Human Heart Valve 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 the standard-processed pulmonary human heart valve. 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 CryoValve 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 andysis provided hepertical and empirical (histological) evidence of tissue stability at cryogenic temperatures.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

MAY 2 5 2010

Re: K092021

CryoValve® SG Pulmonary Valve and CryoValve ® SG Pulmonary Valve and Conduit Regulatory Class: Unclassified Product Code: OHA Dated: March 26, 2010 Received: March 29, 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, 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.

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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 yours,

una R. lahner

Bram 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): K092021

Device Name: CryoValve® SG Pulmonary Valve and CryoValve ® SG Pulmonary Valve and Conduit

Indications For Use: CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------------------------------------------------|----------------|
| | Page 1 of 1 |
| <p> <u>Duma R. Valume</u> </p> <p>(Division Sign-Off)</p> <p>Division of Cardiovascular Devices</p> | |
| 510(k) Number | <u>k092021</u> |