CRYOVALVE SG PULMONARY VALVE AND CONDUIT

K083106 · Cryolife, Inc. · OHA · Feb 6, 2009 · CV

Device Facts

• Record ID: K083106
• Device Name: CRYOVALVE SG PULMONARY VALVE AND CONDUIT
• Applicant: Cryolife, Inc.
• Product Code: OHA · CV
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

CryoValve SG is a human pulmonary heart valve allograft; processed to remove cells and cellular debris; treated with antimicrobial solution; cryopreserved in tissue culture medium. Stored in liquid nitrogen at -135°C to -196°C. Intended for surgical implantation by cardiac surgeons to replace native or prosthetic pulmonary valves or during Ross procedures. Implantation aims to reduce risk of HLA class I and II reactive antibodies compared to standard-processed allografts. Clinical benefit relates to valve replacement for congenital or acquired valvular lesions.

Clinical Evidence

Clinical data analysis provided to support the claim regarding reduced induction of HLA class I and II reactive antibodies measured at up to one year post-implantation compared to standard-processed pulmonary allografts.

Technological Characteristics

Human heart valve allograft; cryopreserved in tissue culture medium; stored at -135°C to -196°C. Processed to remove cells and cellular debris; treated with antimicrobial solution.

Indications for Use

Indicated for patients requiring replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, or 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 Valve (K033484)

Submission Summary (Full Text)

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# 510(K) SUMMARY (K083106)

This 510(k) Summary is 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: CryoValve® SG Pulmonary Valve<br>CryoValve® SG Pulmonary Valve and Conduit<br>Common/Usual Name: Human Heart Valve<br>Proposed Classification Name: Allograft Heart Valve (Product Code: OHA) |

### Intended Use:

.

CryoValve SC Pulmonary Human Heart Valves are indicated for the replacement of diseased, damsuged, malformed, or malfunctioning native or prostherie pulmonary valves. They may also be used in the reparences we infiatively of martinenting marve of procedure is performed. Pulmonary heart valve allografts are used to 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 Valve | CryoLife. Inc.<br>1655 Roberts Blvd., NW<br>Kennesaw, GA 30014 | K033484 - February 07, 2008 | OHA |
| CryoValve® SG<br>Pulmonary Valve and<br>Conduit | | | |

#### Device Description:

The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve SG) is a human hent valvai The Cryolitie, fice C. you ve 35 Friman I. The valve is dissected, treated with an antimierobial solution, and asepted to remove the cells and cellular debris that has not already been removed during the posimorlem treated to renove the centual deenses. The valve is cryopreserved in a tissue vulture medium. period. hervesting, and the antitional process. The thee pouch packaging system. The packaging containing a cryqptolection, within the meether allows for aseptic introduction of the valve into the system not only while the lemperatures, our in begin prior to crystallization to feel have arm operating tolin. Supercenting of informations are transferred to a liquid nitrogen freezer for long-lerm storage at -- 135°C to -196°C.

Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA chass Implantion of the CTS varve SCF Camend Reactive Amibody measured at up to one year. Compared to the I and citiss II and mobile is misser on theat valve. Data have not been provided to evaluate the effect of standard-processed punnolary in the United United Online Form durability, or long-term resistance to rejection by the patient, of the CryoValve SG.

### Analysis Supporting Substantial Equivalence:

A Clinical Data Analysis provides the needed assessment to support the product claim. The Analysis reviews A Cinnell Dall Analysis provides the necesses scientific rationale needed to make this change to the labeling.

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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 stylized eagle with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

### Public Health Service

FEB = 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083106

CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit Regulatory Class: unclassified

Product Code: OHA Dated: January 5, 2009 Received: January 6, 2009

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Mr. John Ferros

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours,

y

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): K083106

# 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 prosihetic 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.

V 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)

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(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K683106 |
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